louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00745342: Optimizing Adherence and Glycemia in Youth With New Insulin-dependent Diabetes Mellitus (IDDM)
Official title: Optimizing Adherence and Glycemia in Youth With New IDDM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: type 1 diabetes
glycemic control
family conflict
quality of life
parental involvement
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-09-03
Enrollment: 105
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2-year randomized, controlled trial examined the impact of a clinic-based, family teamwork intervention on glycemic control in youth with recently diagnosed type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* 8 to 17 years old
* Duration of type 1 diabetes between 2 months and 6 years
* Residence in New England or New York
* At least 1 outpatient visit in the past year

Exclusion Criteria:

* Major co-morbid psychiatric or medical illness in youth
* Diagnosis of an active major psychiatric disorder in either parent
* Diagnosis of a life-threatening medical illness in either parent

Primary outcomes:
measure: Glycemic control, assessed by hemoglobin A1c
timeFrame: 2 years
Secondary outcomes:
measure: Youth quality of life, measured using the youth PedsQL survey and the parent-proxy PedsQL survey
timeFrame: 2 years
measure: Diabetes-specific family conflict, measured using the Diabetes Family Conflict survey (youth and parent versions)
timeFrame: 2 years
measure: Parent involvement in diabetes management tasks, measured using the Diabetes Family Responsibility Questionnaire (youth and parent versions)
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Lori MB Laffel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson BJ, Vangsness L, Connell A, Butler D, Goebel-Fabbri A, Laffel LM. Family conflict, adherence, and glycaemic control in youth with short duration Type 1 diabetes. Diabet Med. 2002 Aug;19(8):635-42. doi: 10.1046/j.1464-5491.2002.00752.x.
citation: Laffel LM, Vangsness L, Connell A, Goebel-Fabbri A, Butler D, Anderson BJ. Impact of ambulatory, family-focused teamwork intervention on glycemic control in youth with type 1 diabetes. J Pediatr. 2003 Apr;142(4):409-16. doi: 10.1067/mpd.2003.138.
citation: Laffel LM, Connell A, Vangsness L, Goebel-Fabbri A, Mansfield A, Anderson BJ. General quality of life in youth with type 1 diabetes: relationship to patient management and diabetes-specific family conflict. Diabetes Care. 2003 Nov;26(11):3067-73. doi: 10.2337/diacare.26.11.3067.
Clinical trial NCT02623842: Radiofrequency Non-ablation in the Treatment of Women With Urinary Stress Incontinence: Study Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Urinary Incontinence
Keywords: urinary incontinence
woman
radiofrequency
Lead sponsor: Centro de Atenção ao Assoalho Pélvico
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pilot study, case series conducted in women with a clinical diagnosis of urinary incontinence and were treated with radiofrequency technique for capacitive transfer non ablative in external urethral meatus. All participants did an hour Pad Test. The participants made five sessions of Radio Frequency (RF) with an interval of seven days between them. The application of RF was performed by physical therapist trained in the technique of radio frequency through the Tonederm® brand device with capacitive transfer method using non-ablative handle with electrode in the region of the external urethral meatro and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration of 20 minutes. The temperature was measured by an infrared thermometer when it reached 41graus radiofrequency was maintained for 2 minutes.


Eligibility criteria: Inclusion Criteria:

* The target audience was made up of women aged between 18 and 65 years with a diagnosis of stress urinary incontinence, referred for physical therapy and who had Pad Test positive criteria by International Continence Society

Exclusion Criteria:

* Were excluded from the study participants with limited understanding, with neurological degenerative chronic diseases, sensory deficit in the genital region, users of pacemaker and intrauterine device of copper and pregnant women

Primary outcomes:
measure: Pad test 1 hour (urinary loss)
timeFrame: one week, one month, two month , three month and six month measure the urinary loss
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centro de Atenção ao Assoalho Pélvico - BAHIANA
name: Patricia V Lordelo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06943742: Non-Helium Magnetoencephalography in Pediatric Brain Tumors
Official title: Non-Helium Magnetoencephalography for Clinical Management of Pediatric Brain Tumors : An Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Brain Tumor
Keywords: Magnetoencephalography
Pediatric Brain Tumor
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
Collaborators: name: Beijing X-Magtech Technology Limited
First posted: 2025-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients of Guangzhou Women and Children's Medical Center

Brief summary: This observational study aims to evaluate the effectiveness of magnetoencephalography (MEG) in the preoperative assessment of pediatric brain tumors, particularly in determining the extent of resection, and compare it with computed tomography (CT) and magnetic resonance imaging (MRI).

The main questions this study aims to answer are:

What is the consistency between MEG and CT/MRI in localizing pediatric brain tumors? What is the clinical efficacy of MEG in determining the extent of resection of pediatric brain tumors preoperatively?

Participants will:

Undergo both MEG and CT/MRI examinations for preoperative assessment, and the extent of tumor resection will be determined by the comprehensive results of the above examinations.

Be followed up with MEG and CT/MRI at 1, 3, and 6 months after surgery, along with neurological and quality-of-life assessments.


Eligibility criteria: Inclusion Criteria:

* Age range: 3-18 years old;
* Clinically diagnosed with brain tumor;
* Capable of cooperating with magnetoencephalography evaluation and recording.

Exclusion Criteria:

* Patients with serious comorbidities or neurological or psychiatric disorders that affect magnetoencephalography examination.
* Patients using drugs that affect central nervous system function;
* Patients who are not suitable for surgical procedures;
* Patients with progressive neurological disorders.

Primary outcomes:
measure: Consistency in Tumor Localization Between Magnetoencephalography (MEG) and Computed Tomography/Magnetic Resonance Imaging (CT/MRI) (Kappa Coefficient)
timeFrame: From enrollment to 12 months after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's medical center
state: Guangdong
Study officials:
References:
Clinical trial NCT03232242: Application of NGS Technique in Precise Diagnosis of Infectious Diseases
Official title: Application of Next Generation Sequencing Technique in Precise Diagnosis of Infectious Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Next Generation Sequencing
Infectious Disease
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Children's Hospital of Fudan University
First posted: 2017-07-27
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that are highly suspected of infectious diseases, and they will be selected mainly from infectious diseases departments .

Brief summary: Infectious disease leads to deaths that accounted for more than 25% of all causes of human mortality. But the traditional microbiological diagnostic methods such as specimen culture are sometimes time-consuming, and have limited sensitivity. And some bacteria, anaerobes and viruses may be difficult to cultivate and isolation. Therefore, the accurate identification and rapid classification of pathogenic microorganisms is very important for the patient's precise diagnosis and timely treatment.

Small-scale studies on the diagnostic efficacy and prognosis of infection in the next generation have been shown to provide early diagnosis and targeted medication guidance for bloodstream infections and respiratory infections, but the larger-scale validation of next-generation sequencing Technology in the diagnosis and treatment of infectious diseases in the human body is relatively rare.

The purpose of this study is to provide rapid etiological diagnosis of patients by means of next-generation sequencing, to change the way of treatment of patients under the existing traditional pathogen detection by means of accurate description of pathogens and monitoring their dynamic changes, and to provide patients with more accurate treatment.


Eligibility criteria: Inclusion Criteria:

* Patients are highly suspected of fever of unknown origin
* Patients are highly suspected of bloodstream infection
* Patients are highly suspected of respiratory infections
* Patients are highly suspected of central nervous system infection

Exclusion Criteria:

* Patients diagnosed as non-infectious diseases such as cancer and autoimmune diseases;

Primary outcomes:
measure: Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of next-generation sequencing in the pathogen detection of infectious diseases
timeFrame: 3 years
Secondary outcomes:
measure: Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of traditional methods in the pathogen detection of infectious diseases
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT02188342: Assessing The Effectiveness of a Preoperative High Intensity Interval Training Programme In Older Colorectal Cancer Patients
Official title: Effectiveness of Short Term, High Intensity, Interval Exercise Training in Older Colorectal Cancer Patients in Improving Preoperative Fitness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative Care
Colorectal Neoplasms
Aged
Exercise
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: University Hospitals of Derby and Burton NHS Foundation Trust
First posted: 2014-07-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary aim of this study is to determine whether an improvement in aerobic fitness, as judged by an increase in VO2peak, can be achieved within 31 days via HIT programme in a group of older, colorectal cancer patients.

Detailed description: 12 high intensity interval training exercise sessions on a static cycle ergometer, over a period of 31 days. Each session lasts 18 minutes.

At the beginning and end of the study the following measures will be used to assess change in fitness, body composition and muscle metabolism. DXA scan, USS of thigh, VO2 peak cycling test, short performance battery tests, quality of life questionnaires and muscle biopsy.

Eligibility criteria: Inclusion Criteria:

* Confirmed colorectal cancer
* Offered curative treatment by the Royal Derby Hospital NHS Foundation Trust Colorectal Cancer Multidisciplinary Team
* Male and female
* 18-88 years of age

Exclusion Criteria:

* Uncontrolled hypertension (BP \> 160/100),
* Angina,
* Heart failure (class III/IV),
* Cardiac arrthymias,
* Right to left cardiac shunt,
* Recent cardiac event,
* Previous stroke/TIA,
* Aneurysm (large vessel or intracranial),
* Severe respiratory disease including pulmonary hypertension,
* COPD/asthma with an FEV1 less than 1.5 l,
* Coagulation disorders,
* Scarring disorders.
* Current neoadjuvant chemo/radiotherapy
* Inability to complete the consent process Involvement in invasive research study in previous 3 months.

Primary outcomes:
measure: VO2 peak
timeFrame: After 31 days of HIT
Secondary outcomes:
measure: Anaerobic threshold
timeFrame: After 31 days of HIT
measure: Muscle protein synthesis
timeFrame: After 31 days of HIT
measure: Body composition
timeFrame: After 31 days of HIT
measure: Feasibility
timeFrame: After 31 days of HIT
measure: Quality of life
timeFrame: After 31 days of HIT
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: University of Nottingham
state: Derbyshire
Study officials:
affiliation: University of Nottingham
name: John Williams, BSc MBChB FRCA PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00734942: Development and Implementation of Evidence-Based Family-Oriented Support for Young Carers and Their Families in Germany
Official title: Improved Health-Related Quality of Life for Young Carers and Their Families in Germany on the Basis of Evidence-Based Family-Oriented Support
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Illness
Keywords: young carers
family support
children (up to the age of 18) of chronically ill parents
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2008-08-14
Enrollment: 150
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to develop and implement evidence-based and family-oriented support for young carers and their families in Germany. Hypothesis is that families' own support mechanisms, combined with externally provided support that is determined by the families' specific needs, will help to overcome their burden and enable families to live in the way they wish to despite chronic illness. This will lead to a measurable increase in HRQOL of children concerned.


Eligibility criteria: Inclusion Criteria:

* children of mentally ill parents (chronic illness)
* children of somatically ill parents (chronic illness)

Exclusion Criteria:

* children of drug addicted parents

Primary outcomes:
measure: health-related Quality of Life in children
timeFrame: study start and after 5 month of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Witten
country: Germany
facility: Institute of Nursing Science
state: NRW
Study officials:
affiliation: Institute of Nursing Science; Witten/Herdecke University
name: Sabine Metzing-Blau, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Nursing Science; Witten/Herdecke University
name: Wilfried Schnepp, Prof.Dr.
role: STUDY_DIRECTOR
References:
citation: Metzing S, Schnepp W. [The impact of caring on young carer's lives. An international literature review (1990-2006)]. Pflege. 2007 Dec;20(6):331-6. doi: 10.1024/1012-5302.20.6.331. German.
citation: Sabine M, Schnepp W. [Children and adolescents as caregivers: who they are and what they do. An international literature review (1990-2006)]. Pflege. 2007 Dec;20(6):323-30. doi: 10.1024/1012-5302.20.6.323. German.
citation: Schlarmann JG, Metzing-Blau S, Schnepp W. The use of health-related quality of life (HRQOL) in children and adolescents as an outcome criterion to evaluate family oriented support for young carers in Germany: an integrative review of the literature. BMC Public Health. 2008 Dec 17;8:414. doi: 10.1186/1471-2458-8-414.
citation: Schlarmann JG, Metzing S, Schoppmann S, Schnepp W. Germany's First Young Carers Project's Impact on the Children: Relieving the Entire Family. A Qualitative Evaluation. Open Nurs J. 2011;5:86-94. doi: 10.2174/1874434601105010086. Epub 2011 Oct 26.
Clinical trial NCT00924742: A Single-Dose Pharmacokinetics Study of Tapimycin Injection
Official title: A Single-Dose Pharmacokinetics Study of Tapimycin Injection(Piperacillin 4 g + Tazobactam 0.5 g Powder for Injection) Administered Under Fasting Conditions to Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: The PK of Tapimycin
volunteer
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2009-06-19
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to examine the pharmacokinetic properties of Tapimycin injection (piperacillin 4 g + tazobactam 0.5 g powder for injection) in healthy volunteers under fasting conditions.


Eligibility criteria: Inclusion Criteria:

1. Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
2. Healthy adult male, aged between 20 and 40 years old.
3. Body Mass Index (BMI) between 18.5 and 25.
4. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
5. No significant deviation from normal biochemistry.
6. No significant deviation from normal hematology.
7. No significant deviation from normal urinalysis.

Exclusion Criteria:

1. History of drug or alcohol abuse within the past year.
2. Medical history of severe drug allergy or sensitivity to analogous drug.
3. Acute or chronic diseases or having undergone surgery from 4 weeks prior to PeriodI dosing.
4. Any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
5. Ongoing peptic ulcer and constipation.
6. Planned vaccination during the time course of the study.
7. Taking any clinical study drug from 3 months prior to Period I dosing.
8. Use of any medication, including herb medicine or vitamins from 4 weeks before the study.
9. Blood donation of more than 500 mL within the past 3 months.
10. A positive Hepatitis B surface antigen or positive Hepatitis C antibody.
11. A positive test for HIV antibody.

Primary outcomes:
measure: To examine the pharmacokinetic properties
timeFrame: 8.5 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tri-Service General Hospital
name: Feng-Yee Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00364442: Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics
Official title: A Repeat Dose, Randomised, Double Blind, 2-way Crossover Study to Assess the Safety and Systemic Exposure of an Investigational Formulation Compared to Concurrent Administration of Individual Fluticasone Propionate 50 and Salmeterol 50 DISKUS Inhalers in Subjects Aged 18 - 55 Years With Mild Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone propionate and salmeterol was compared with concurrent administration of fluticasone propionate and salmeterol. Administration occurred over 14 days and tolerability, PK (pharmacokinetic) and PD (pharmacodynamic) measurements were performed.


Eligibility criteria: Inclusion criteria:

* Documented history of mild or intermittent asthma
* Have PEF and FEV1\>80% predicted
* Not a smoker
* BMI of 19 - 29

Exclusion criteria:

* Have had a life threatening episode of asthma
* Have had a respiratory tract infection in the last four weeks
* Have other respiratory disease
* Have taken certain medications within restricted time periods

Primary outcomes:
measure: The primary objective was to look at the safety and tolerability of a low dose of fluticasone propionate/salmeterol compared to concurrent administration of fluticasone propionate and salmeterol
timeFrame: Administration occurred over 14 days and tolerability
Secondary outcomes:
measure: Comparing changes in PD parameters & PK parameters between a low dose of fluticasone propionate/salmeterol compared to concurrent administration of fluticasone propionate and salmeterol
timeFrame: Administration occurred over 14 days and tolerability
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: This study has not been published in the scientific literature.