louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04686734: Long-term Effects of COVID-19 in Adolescents
Official title: Long-term Effects of COVID-19 in Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 516
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents living in the counties of Oslo and Viken, Norway

Brief summary: The overarching objective for this prospective cohort study of COVID-19 in adolescents is to study the long-term effects, with particular emphasis on post-infectious chronic fatigue. A total of 500 individuals with a SARS-CoV-2 positive test will be enrolled in the acute phase of COVID-19 and followed for 6 months. A total of 100 individuals with SARS-CoV-2 negative test will be included during the same time period as a control group. Investigations include autonomic, pulmonary and cognitive assessement; a questionnaire charting symptoms, emotionality, personality, loneliness, life events and demographics; and extensive biobanking including genetic markers, viable PBMC, urine, feces and hair. A subgroup of 40 SARS-CoV-2 positive and 20 SARS-CoV-2 negative individuals will also undergo detailed cardiological examination by echocardiography. Primary endpoints are fatigue at 6 months as assessed by the Chalder Fatigue Scale and post-COVID-19 syndrome cases at 6 months according to the WHO definition


Eligibility criteria: Inclusion Criteria:

* Positive SARS-CoV-2 test/negative SARS-CoV-2 test
* Age 12 - 25 years
* Living in the counties of Oslo or Viken, Norway
* \< 28 days since onset of first symptom

Exclusion Criteria:

* Hospitalised due to COVID-19
* Pregnancy
* Lack of consent

Primary outcomes:
measure: Fatigue
timeFrame: 6 months follow-up
measure: Post-COVID-19 syndrome caseness
timeFrame: 6 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Vegard Bratholm Wyller
Study officials:
affiliation: University Hospital, Akershus
name: Vegard B Wyller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lund Berven L, Selvakumar J, Havdal L, Stiansen-Sonerud T, Einvik G, Leegaard TM, Tjade T, Michelsen AE, Mollnes TE, Wyller VBB. Inflammatory Markers, Pulmonary Function, and Clinical Symptoms in Acute COVID-19 Among Non-Hospitalized Adolescents and Young Adults. Front Immunol. 2022 Feb 9;13:837288. doi: 10.3389/fimmu.2022.837288. eCollection 2022.
Clinical trial NCT05725434: A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Active Rheumatoid Arthritis
Official title: A Single-arm, Open-label, Multiple-dose, Phase 3 Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Moderate to Severe Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2023-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 3 study to evaluate the usability of the CT-P47 auto-injector in patients with moderate to severe active rheumatoid arthritis.

Detailed description: CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to RoActemra/Actemra. The purpose of this study is to evaluate the usability of the CT-P47 auto-injector in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.

Eligibility criteria: Inclusion Criteria:

* Patient is male or female aged 18 to 70 years old, both inclusive.
* Patient must be able and willing to self-administer SC injections.
* Patient has had a diagnosis of RA according to the 2010 ACR/EULAR classification criteria (Aletaha et al., 2010) for at least 24 weeks prior to the first administration of the study drug (Day 1).

Exclusion Criteria:

* Patient who has previously received investigational or licensed product; targeted synthetic DMARD(s) (e.g., tofacitinib, baricitinib) for the treatment of RA and/or an interleukin-6 (IL-6) inhibitor for any purposes.
* Patient who has previously received more than 1 biologic agents approved for the treatment of RA.
* Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.

Primary outcomes:
measure: The usability of AI as assessed by patients rating using POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 2.
timeFrame: Week 2
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: INTER CLINIC Piotr Adrian Klimiuk
name: Klimiuk Piotr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01287234: Atrio-Ventricular (AV) Delay Optimization Using Echocardiography Versus the SonR Signal
Official title: Atrio-Ventricular Delay Optimization in Patients Implanted With a Cardiac Resynchronization Device Using Echocardiography Versus the SonR Signal: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Piedmont Healthcare
Sponsor class: OTHER
Collaborators: name: LivaNova
First posted: 2011-02-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate an external device (SonR sensor) that is capable of detecting sounds created by the heart (SonR signal). Based on the sounds created by the heart and recorded by the SonR sensor, optimal timing settings for the cardiac resynchronization therapy defibrillator (CRT-D) device may be determined. The investigators will then compare the timing settings suggested by SonR to the settings suggested from the echocardiogram. The objective of this study is to determine if differences exist between these different methods of timing the contractions of the top and bottom chambers of the heart and if the SonR signal is able to produce results similar to those of an echocardiogram.


Eligibility criteria: Inclusion Criteria:

* Implanted with any current Food and Drug Administration (FDA) approved CRT- D device and leads for 30 days or patients indicated for AV optimization
* ≥18 years of age
* Ability and willingness to provide written informed consent and HIPAA authorization

Exclusion Criteria:

* Chronic Atrial Fibrillation
* Heart Failure decompensation event within two weeks of enrollment
* Hypertrophic Obstructive Cardiomyopathy
* Patient currently enrolled in another ongoing clinical trial
* Pregnancy
* Less than 18 years of age
* Inability or unwillingness to provide written informed consent and HIPAA authorization

Primary outcomes:
measure: Optimal blood flow method
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
Study officials:
affiliation: Piedmont Heart Institute
name: Dan Dan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06315634: Intrathecal Dexmedetomidine vs Midazolame
Official title: Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries

Detailed description: Comparison of intrathecal dexmedetomidine plus Bupivacaine vs intrathecal midazolam plus Bupivacaine on duration of sensory and motor blockade and hemodynamic parameters of patients

Eligibility criteria: Inclusion Criteria:

* Patients undergoing lower limb orthopedic cancer surgery.
* ASA I, II, III.
* Age 20 to 70 year
* Healthy volunteers

Exclusion Criteria:

* Age less than 20 and older than 70.
* ASA IV, V.
* patients' refusal.
* patients with coagulopathy.
* patients with severe valvular stenosis
* patients with infection at site of injection

Primary outcomes:
measure: Duration of sensory block
timeFrame: 12 hours
Secondary outcomes:
measure: Incidence of vomiting occurrence
timeFrame: 12 hours
measure: Sedation
timeFrame: 12 hours
measure: Change in mean arterial blood pressure
timeFrame: 12 hours
measure: Duration of motor block
timeFrame: 12 hours
measure: Change in heart rate
timeFrame: 12 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National cancer institute
Study officials:
affiliation: NCI Egypt
name: Mohamed Elwasef, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04173234: Aerobic Exercise in Duchenne Muscular Dystrophy
Official title: The Effect on Muscle Architecture Properties and Motor Functions of Aerobic Training in Children With Duchenne Muscle Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Keywords: Duchenne Muscular Dystrophy
Aerobic Training
Ultrasonography
Motor Function
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 19
Sex: MALE
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

Brief summary: Duchenne Muscular Dystrophy (DMD) is the most common neuromuscular disease in childhood with an estimate incidence of 1 in 3500 to 5000 male births. The effect of aerobic training on muscle architectural properties and motor functions such as muscle activation is not clear in DMD. The aim of this study is to investigate the effects of aerobic training on these parameters in children with DMD. Twenty children with DMD included in the study will be divided into two groups as home program and home program+aerobic training with block randomization method. Home program including stretching, respiratory, range of motion and mild resistance exercise with body weight will be asked to apply 3-5 days a week for 12 weeks, aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 50 minutes total duration consisting of 10 min warm up and 10 min cool down period. Muscle architectural properties, muscle strength, muscle activation and motor function will be assessed with ultrasonographic, hand-held myometry, surface EMG and Motor Function Measure, consecutively. Assessments will be applied at pre-training and after 12 weeks of training.


Eligibility criteria: Inclusion criteria:

* Children had diagnosis of DMD confirmed by genetic analysis,
* Children had functional level of Grade 1 and 2 according to Vignos Scale.

Exclusion criteria:

* Children had undergone any surgery or suffered injury of the lower limbs,
* Children had comorbid disease
* Children were applied regular aerobic training in last 6 months.

Primary outcomes:
measure: Evaluation of Muscle Thickness, Fascicle Length, Pennation Angle with Ultrasonography
timeFrame: 10 minutes
Secondary outcomes:
measure: Assessment of Motor Function by Motor Function Measure (MFM)
timeFrame: 30 minutes
measure: Evaluation Motor Performance with Timed Functional Test and Six minute walk test
timeFrame: 20 minutes
measure: Shortening assessment of trunk and lower extremity muscles with goniometric measurement and tape
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation
state: Altındağ
Study officials:
References:
Clinical trial NCT02264834: Deambulatory Epidural During the Labour
Official title: Comparison of Two Different Peridural During the Labor and Effect of Deambulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: First Pregnancy
Keywords: epidural
primiparous patient
deambulation
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2014-10-15
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess the impact of instrumentation and caesarean related to dyskinesia by reducing the concentration of local anesthetic and therefore the motor block.

Detailed description: Prospective, randomized and double-blind study performed on primiparous parturient divided into two distinct groups.

Eligibility criteria: Inclusion Criteria:

* Free written consent.
* ASA I or II,
* Primipara, unique and pregnancy over 36 weeks fetus in cephalic, cervical dilation between 3-6 cm
* VAS\> 30 mm
* No contraindications to peridural

Exclusion Criteria:

* Twin pregnancy, less than 36 weeks and 42 weeks
* Fetus in breech position
* Analgesia and sedation within 6h
* Contraindications to peridural

Primary outcomes:
measure: Time between peridural application and childbirth
timeFrame: at delivery
measure: Caesarian
timeFrame: at delivery
measure: Instrumentalisation
timeFrame: at delivery
measure: Apgar score of the baby
timeFrame: at delivery
Secondary outcomes:
measure: Bromage score
timeFrame: 1h after the start of the peridural
measure: Romberg test
timeFrame: 1h after the start of the peridural
measure: Arterial tension
timeFrame: 1h after the start of the peridural
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: CHUB
Study officials:
affiliation: CHUB
name: Philippe Vanderlinden
role: STUDY_DIRECTOR
References:
Clinical trial NCT01504217: Control of Center of Mass to Predict Balance Ability and Fall Risks in Elderly
Official title: Analysis of Muscle Strength and Control of Center of Mass Acceleration Mechanism to Predict Balance Ability and Fall Risks in Elderly
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: Healthy older people over 65 years old
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: community sample

Brief summary: Falling among older adults is a major public health concern. In fact, falls are the leading cause of accidental death in older adults both in Taiwan and in the United States. In order to provide effective preventative strategies, the investigators must understand the mechanisms that cause older adults to fall. Thus, the investigators research aim for three objectives: (1) using biomechanical model to identify the deficits in neuromuscular control for older adults (2) to apply research findings to the development of new clinical methods for assessing and recovering balance control in older adults, and (3) to predict fall risks in 1-2 year for older adults from the research findings.


Eligibility criteria: Inclusion Criteria:

1. can stand for 5 minutes without support
2. with normal or corrected to normal vision
3. age between 20-35 years old for young adults group, and 65-80 years old for older adults group
4. had fall history in the past 3 years for the older adults group.

Exclusion Criteria:

1. pregnant women
2. with cancer diagnosis
3. with sensory-motor deficits
4. with osteoporosis for older adults group (T-score below -2.5)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School & Graduate Institute of Physical Therapy College of Medicine, National Taiwan University
Study officials:
affiliation: National Taiwan University Hospital
name: Wei-Li Hsu, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02523417: HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）for Breast Cancer
Official title: HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA for Breast Cancer: Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: Breast Cancer
HepaSphere
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）for breast cancer.

Detailed description: By enrolling patients with breast cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）for breast cancer.

Eligibility criteria: Inclusion Criteria:

1. Age:18-80
2. Karnofsky performance status \>60
3. Diagnosis of breast cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive interventional therapy
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except breast cancer
2. History of coagulation disorders or anemia

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of lesions interventional therapy that show no sign of recurrence 12 months after
timeFrame: 1 year
measure: Progress free disease (PFS)
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 3 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Central laboratory in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PhD
role: STUDY_CHAIR
References:
citation: Niu L, Chen J, Yao F, Zhou L, Zhang C, Wen W, Bi X, Hu Y, Piao X, Jiang F, Zeng J, Liu W, Li J, He L, Mu F, Zuo J, Xu K. Percutaneous cryoablation for stage IV lung cancer: a retrospective analysis. Cryobiology. 2013 Oct;67(2):151-5. doi: 10.1016/j.cryobiol.2013.06.005. Epub 2013 Jun 24.
Clinical trial NCT05070234: Genetic Diagnosis and Human Growth Hormone Treatment in Small for Gestational Age Children With Short Stature
Official title: Genetic Diagnosis and the Response to Recombinant Human Growth Hormone Treatment in Small for Gestational Age Children With Short Stature
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Small for Gestational Age Infant
Silver-Russell Syndrome
Genetic Diseases, Inborn
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Children's Hospital
name: Second Affiliated Hospital of Guangzhou Medical University
name: Shenzhen Children's Hospital
name: Tongji Hospital
name: The Children's Hospital of Zhejiang University School of Medicine
name: Chengdu Women's and Children's Central Hospital
name: West China Second University Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: Changchun GeneScience Pharmaceutical Co., Ltd.
First posted: 2021-10-07
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children's hospical

Brief summary: This study is a multi-center, retrospective and non-interventional research. In this study, a total of 150 short children who were small for gestational age and had been treated with recombinant human growth hormone (rhGH) are selected for genetic testing. The aims of this study are to analyze the genetic etiology of SGA children with short stature, and to compare the efficacy and safety of rhGH treatment in subjects with different etiologies.


Eligibility criteria: Inclusion Criteria:

1. Single birth, clinical diagnosis of SGA;
2. rhGH treatment beginned before puberty (Tanner stage I), regardless of gender;
3. Before starting rhGH treatment, height was lower than -2 SDS compared with normal children of the same age and sex;
4. All the subjects and their guardians signed the informed consent and the informed consent for genetic testing.

Exclusion Criteria:

1. No efficacy and safety data were recorded after treatment with rhGH;
2. A history of blood transfusion within 3 months before the collection of the genetic blood samples, or a history of bone marrow transplantation between rhGH treatment and the enrollment in this study;
3. Other conditions that the investigator considered unsuitable for inclusion in this study.

Primary outcomes:
measure: Genetic testing
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Children's Hospital
name: Chunxiu Gong, doctor
role: PRINCIPAL_INVESTIGATOR
References: