louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01055548: PPrime: Parents Views on Diagnosis and Information-giving in Neonatal Care (Pilot Study)
Official title: Parents Views on Diagnosis and Information-giving in Neonatal Care (Pilot Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parents of Preterm Infants Born Before 33 Weeks Gestation
Keywords: Preterm
Perinatal
Ultrasound
Cerebral palsy
Anxiety
Parents
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2010-01-25
Enrollment: 20
Sex: ALL
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of babies born before 33 week's gestation

Brief summary: The aim of the pilot study is to explore and identify the issues of concern to parents whose babies have been cared for in a neonatal unit and exposed to imaging, its influence on diagnosis and information-giving process

Detailed description: The aim is to explore the recent experience and views of parents in a qualitative way to assist the development of a questionnaire which can be used with a much larger group of parents. The interview guide with the topics to be covered will include: expectations, concerns and issues relating to the equipment used with their baby, any investigations, including cranial ultrasound and MR imaging and the information provided.

The data collected will then inform the development of a standard instrument or questionnaire which will be used with parents participating in a trial using a randomised design to compare the influence of MR and ultrasound-based information on parental perceptions, stress and coping in association with healthcare usage and costs.

Eligibility criteria: Inclusion Criteria:

* Parents of babies born before 33 weeks gestation Parents who are 16 years of age or older Parents who are able to give informed consent Parents who are able to take part in interviews which are conducted in English

Exclusion Criteria:

* Parents who are under 16 years of age Parents who are unable to give informed consent Parents who are unable to take part in interviews which are conducted in English Parents where there are possible or know child protection issues

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: Imperial College London
name: Professor D Edwards
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Dr D Azzopardi
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Dr M Redshaw
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05041348: Metabonomic of Patients With Hepatitis B Cirrhosis Complicated With Sarcopenia.
Official title: Affiliated Hospital of Qingdao University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Keywords: Hepatitis B virus-related liver cirrhosis
muscle mass loss
metabolites
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HBV-related liver cirrhosis were recruited between August 2021 and June 2022 at the Affiliated hospital of Qingdao University. All of the patients are in the decompensation stage of hepatitis B cirrhosis and divided them into two groups. One group is named cirrhosis with muscle mass loss, the other group is named liver cirrhosis with normal muscle mass. People in healthy control group were excluded metabolic diseases. Each group of patients is about 20.

Brief summary: Sarcopenia is a common complication in liver cirrhosis patients and has been confirmed that associated with poor prognosis. China has the world's largest burden of hepatitis B virus-related liver cirrhosis (HBV-related liver cirrhosis). However, the relationship between HBV-related liver cirrhosis patients with muscle mass loss and normal muscle mass is remain largely unknown. Our study aimed to reveal the metabolic profile and identify potential biomarkers of muscle mass loss in HBV-related liver cirrhosis.


Eligibility criteria: Inclusion Criteria:

1. the diagnostic criteria for decompensation of liver cirrhosis of chronic viral hepatitis B formulated according to the Guidelines for Diagnosis and Treatment of Liver Cirrhosis issued by the Chinese Society of Hepatology in 2019
2. The diagnosis of muscle mass loss conforms to SMI less than 46.96 cm²/m² for males and less than 32.46 cm²/m² for females
3. Patients aged between 18 and 60 years old
4. Patients with no history of drinking or abstinence for more than 1 year
5. Voluntary participants with informed consent

Exclusion Criteria:

1) the etiology of cirrhosis without hepatitis B virus (HBV), such as cirrhosis, alcoholic cirrhosis, autoimmune cirrhosis, and so on; 2) the age of patients over 60 years old; 3) patients with acute, chronic and acute liver failure; 4) other diseases which can lead to the secondary muscle depletion, such as chronic disease in heart, lung, kidney, brain, and malignant tumor; 5) neurodegenerative diseases or muscle degenerative diseases; 6) perioperative patients; 7) patients without CT scan within 3 months; 8) patients who have exercise habits with the Physical Activity Rating Scale-3 (PARS-3) \> 19 points

Primary outcomes:
measure: amino acids metabolism
timeFrame: 2021.09.01-2022.08.01
measure: central carbon metabolism
timeFrame: 2021.09.01-2022.08.01
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
Study officials:
References:
Clinical trial NCT05366348: The Effects of Horse-back Riding on Core Muscles in Adolescents
Official title: Investigation of the Effects of Horse-back Riding on Core Muscles in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health, Subjective
Activity, Motor
Muscle Strength
Keywords: Balance
Core stability
Adolescent
muscle strength
horseback riding
Lead sponsor: Sanko University
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to examine the effects of riding on the core muscles, balance and muscle strength of the extremities in healthy adolescents.

Core strength, core endurance, balance, upper extremity and lower extremity strength assessments were performed on the study group before and after the riding training.

Detailed description: Twenty participants, aged between 10-19 years, research (n=10) and control (n=10) groups, were included in the study. The study group (n=10) received riding training for eight weeks. The study group was evaluated twice before and after riding.The control group only participated in the assessments at the start of the study. Demographic information of all volunteer participants were recorded.

Core strength was evaluated with a stabilizer pressure biofeedback device, and core endurance was evaluated with isometric endurance tests. Balance was evaluated with Star Excursion Balance Test, upper extremity strength was evaluated with hand dynamometer and lower extremity strength was evaluated with back-leg dynamometer.

Eligibility criteria: Inclusion Criteria:

* Individuals between the ages of 10-19 years
* No previous horse-back riding experience
* Individuals with no health problems

Exclusion Criteria

* Any history of surgery intervention
* Individuals who do not regularly participate in horse-back riding

Primary outcomes:
measure: Core stability
timeFrame: 8 weeks
Secondary outcomes:
measure: Balance
timeFrame: 8 weeks
measure: Extremity strength
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: SANKO University
Study officials:
affiliation: Sanko University
name: Pınar Kuyulu, MsC(c)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01211548: Coronary CT Angiography in Aneurysms Repaired With Open or Endovascular Approach
Official title: Coronary CT Angiography in Aneurysms Repaired With Open or Endovascular Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complex Aortic Surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2010-09-29
Enrollment: 40
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: All patients being considered for a complex aortic surgery and undergoing medically indicated contrast enhanced CT aortic angiography of the chest abdomen and pelvis will be includedRaw data from CT coronary angiography will be available from all patients.

Brief summary: This proposal is for the pilot study that will inform the conduct of a larger prospective randomized controlled trial to guide perioperative work up and the cost/utility of CTCA (high definition CT coronary angiography.)

Detailed description: This proposal is for a pilot study that will inform the conduct of a prospective, blinded randomized controlled trial designed to determine the cost effectiveness of an algorithm for pre operative cardiac risk stratification that uses coronary CT angiography. In addition perioperative and long-term cardiac event rate will be recorded to determine if there is any difference in these rates between the 2 groups.

Eligibility criteria: Inclusion Criteria:

* patients being considered for a complex aortic surgery and undergoing medically indicated contrast enhanced CT aortic angiography of the chest abdomen and pelvis

Exclusion Criteria:

* Patients with contraindications to undergoing CT coronary angiography
* coronary revascularization within the last six months
* renal dysfunction in whom the treating physician has decided a contrast enhanced CT scan is not warranted as part of the routine clinical work up

Primary outcomes:
measure: The primary outcome for the pilot study will be to assess feasibility of processes as set out in the specific aims.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04254848: Oral Stereognosis in Completely Edentulous Patient With Maxillary Tori
Official title: Evaluation of Oral Stereognosis in Completely Edentulous Patient With Maxillary Tori
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Torus Palatinus and Torus Mandibularis
Keywords: oral stereognosis
completely edentulous
Lead sponsor: Segi University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aimed to evaluate the oral stereognosis in completely edentulous patients with palatal tori. Oral stereognosis is tested using different test specimens in completely edentulous patients with maxillary tori and completely edentulous patients without maxillary tori.

Detailed description: Oral Stereognosis has been defined as appreciation of the form of objects that is explored intra-orally. In this study the oral stereognosis is determined by placing objects of various shapes in the patient's mouth and having the patient identify the correct form. Several studies has proved that oral stereognosis ability (OSA) can be used as a predictor for determining the ability of the patients with missing teeth to adapt to a new prosthesis placed in the patient's mouth.

Maxillary tori is a non-cancerous bony swelling found in palate and have high prevalence among Malaysian population. Whether OSA is higher or lower in patients with maxillary tori is not known.

Eligibility criteria: Inclusion Criteria:

* Complete edentulous patient with maxillary tori and without maxillary tori
* Complete edentulous patient who were willing give consent and eager to participate

Exclusion Criteria:

* Patients with swallow and mastication dysfunction
* Patients with cognitive disturbances
* Uncooperative patients.
* Patients with oral lesions, pathologies and Tempromandibular Joint disorders.
* Patients with systemic diseases
* Patients allergic to acrylic resin

Primary outcomes:
measure: changes in the oral stereognosis
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Faculty of Dentistry, SEGi University
state: Selangor
Study officials:
affiliation: Senior Lecturer, Faculty of Dentistry, SEGi University, Malaysia
name: Indumathi Sivakumar, MDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ikebe K, Amemiya M, Morii K, Matsuda K, Furuya-Yoshinaka M, Nokubi T. Comparison of oral stereognosis in relation to age and the use of complete dentures. J Oral Rehabil. 2007 May;34(5):345-50. doi: 10.1111/j.1365-2842.2007.01687.x.
citation: Park JH. Changes in oral stereognosis of healthy adults by age. J Oral Sci. 2017;59(1):71-76. doi: 10.2334/josnusd.16-0366.
citation: Mantecchini G, Bassi F, Pera P, Preti G. Oral stereognosis in edentulous subjects rehabilitated with complete removable dentures. J Oral Rehabil. 1998 Mar;25(3):185-9. doi: 10.1046/j.1365-2842.1998.00221.x.
Clinical trial NCT06473948: To Assess the Effects of Single Dose of JMKX001899 on QTc Interval in Healthy Subjects
Official title: A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Effect of JMKX001899 on the QTc Interval in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Solid Tumor, Adult
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
First posted: 2024-06-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Study to assess the effect of JMKX001899 on QTc interval in healthy volunteers

Detailed description: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of JMKX001899 Administered as a Tablet Formulation Under Fed Conditions in Healthy Subjects

Eligibility criteria: Inclusion Criteria:

1. Healthy, adult, male or female 18-45 years of age, inclusive.
2. Body mass index (BMI) between 19 and 28 kg/m2 (inclusive) and weight at least 50 kg.
3. Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

Exclusion Criteria:

1. Patients with a history of clinically significant diseases including, but not limited to, gastrointestinal, renal, liver, neurological, hematological, endocrine, neoplastic, pulmonary, immune, psychiatric, or cardiovascular and cerebrovascular diseases, epilepsy, bipolar disorder/mania, intraocular hypertension, or acute angle-closure glaucoma.
2. Female subjects with a positive pregnancy test or lactating.
3. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or Treponema pallidum（TP-Ab）

Primary outcomes:
measure: To evaluate the effect of a single dose of JMKX001899 on the change in time-matched QTc intervals compared with placebo
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01782248: Self-consciousness in Dementia
Official title: Self-consciousness in Dementia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Fronto-temporal Lobar Dementia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2013-02-01
Enrollment: 65
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to characterize the deficit in critical components of personal identity (self-consciousness and social cognition) in patients with Alzheimer's disease (AD) and fronto-temporal lobar dementia (FTLD), compared to healthy elderly, combining a neuropsychology and multi-podal neuroimaging study.

We posit that the alteration of some aspects of self-consciousness (autobiographical memory, nosognosia, metacognition) and social cognition (theory of mind and facial) results in personality changes in the patients, primarily due to the alteration of self-consciousness in AD and to social cognition in FTLD.


Eligibility criteria: Inclusion Criteria:

* AD (McKhann et al, 1984 and Dubois et al, 2007) or FTLD (Neary et al, 1998 or Rascovsky et al, 2011)
* MMSE \> or = 18
* Relative avaible

Exclusion Criteria:

* Contraindication to MRI
* Major depression
* Other central neurological condition

Primary outcomes:
measure: Characterize the deficit in critical components of personal identity in patients with Alzheimer's disease (AD) and fronto-temporal lobar dementia (FTLD), compared to healthy elderly, combining a neuropsychology and multi-podal neuroimaging study.
timeFrame: each month for 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT01246648: Chronic Presence of Epstein Barr Virus in Sulcular and Junctional Epithelial Tissue From Gingiva is Associated With Severe Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parodontitis Aggressive
Parodontitis Chronic
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2010-11-23
Enrollment: 6
Sex: MALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The etiopathogenesis of periodontal disease results from complex interaction between infectious agents, mainly including bacteria, and host cellular and humoral immune responses. However it is thought that bacteria-induced pathogenesis is not sufficient alone to explain all biological and clinical features of the destructive periodontal disease. The main hypothesis is that herpesviruses, such as Epstein-Barr Virus, may participate as well by altering epithelial gingival cell biology and consequently may promote the initiation and progression of periodontitis.


Eligibility criteria: Inclusion Criteria:

* Men exclusively
* 12 years minimum
* 2 patients affected by chronic periodontitis
* 2 patients affected by aggressive periodontitis
* 2 healthy patients (orthodontics extraction)
* Subject who have read and understood the information note relative under investigation and who have signed the informed consent
* Subject whose legal representative signed the parental consent (if minor patient)

Exclusion Criteria:

* Patient with contre-indication to dental extraction
* Patient witn serious blood disease
* Patient who exhibits systemic condition incompatible with the realization of the study
* Patient treated with oral retinoids, bisphosphonates, oral anticoagulants and anticonvulsivants
* Patient who presents za buccal carcinoma treated with radiotherapy
* Patient who have received during the past 6 months: anti-inflammatory drugs, anti-cancerous or immunosuppressive chemiotherapy
* Patient who presents a linguistic or psychic incapacity to understand information
* Female patient

Primary outcomes:
measure: Presence/absence of EBV in the epithelial cells of periodontal pockets (by Immunofluorescence and in situ Hybridization
timeFrame: at time = 0 (baseline)
Secondary outcomes:
measure: Presence/ absence of latency and/or lytic proteins (by immunofluorescence and in situ hybridization
timeFrame: at time = 0 (baseline)
measure: - Epithelial tissue infected (by Immunofluorescence and In situ Hybridization) : detection of oral gingival epithelium, sulcular epithelium, junctional epithelium.
timeFrame: at time = 0 (baseline)
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice, Hôpital Saint Roch
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: VINCENT Severine, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01285648: Study of CPAP as Intervention After Lung Resection
Official title: APPLICATION OF CONTINUOUS POSITIVE AIRWAY PRESSURE IN POSTOPERATIVE OF LUNG RESECTION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Pulmonary Complications
Keywords: chest tubes,
Continuous Positive Airway Pressure,
lung resection, thoracic surgery,
noninvasive ventilation,
postoperative
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2011-01-28
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the oxygenation index (OI), dyspnea, and pain scale and evaluate the duration of thoracic drainage and pleural air leaks after lung resection in two groups of patients: chest physiotherapy (CP) patients and combined CP and Continuous Positive Airway Pressure (CPAP) patients.

Detailed description: In pulmonary resection surgery complications that lead to significant functional losses of the lung parenchyma and alterations in the ventilatory function may trigger retention of secretions, atelectasis, pneumonia and respiratory failure, which prolong the duration of mechanical ventilation and hospitalisation and contribute to the increase in risk of mortality.

In this study the oxygenation index (OI), Borg Scale, pain scale and the presence and duration of thoracic drainage was determined in the immediate postoperative (POi) period and in the first and second postoperative (PO1, PO2) days in 40 patients who underwent elective lung resection.

Similar to Chest Physiotherapy, the preventive application of CPAP in the postoperative period after lung resection in our study also appeared to be a safe technique, which allowed improved oxygenation without increasing air leaks through the thoracic drains.

Eligibility criteria: Inclusion Criteria:

* medical diagnosis of lung cancer and an indication for lung resection (lobectomy, bilobectomy and pneumonectomy) with posterolateral thoracotomy;
* aged between 40 and 75 years.

Exclusion Criteria:

* Patients who refused to participate in the survey;
* lung resection with incisions other than posterolateral;
* patients who had contraindications to the use of noninvasive ventilation.

Primary outcomes:
measure: Bubbling drains
timeFrame: From immediate postoperative until fifth, along the study, in a total of one year
Secondary outcomes:
measure: Pain score
timeFrame: Reported pain score after lung resection, along the study, during one year
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Campinas State University
state: São Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Lígia S. Roceto
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roceto Ldos S, Galhardo FD, Saad IA, Toro IF. Continuous positive airway pressure (CPAP) after lung resection: a randomized clinical trial. Sao Paulo Med J. 2014;132(1):41-7. doi: 10.1590/1516-3180.2014.1321525.