louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01399229: Comparison of SureCALL® Labor Monitor® and Tocodynamometer Measurement in Preterm and Term Pregnant Women
Official title: Comparison of SureCALL® Labor Monitor® and Tocodynamometer Measurement in Preterm and Term Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: Reproductive Research Technologies, LP
Sponsor class: INDUSTRY
First posted: 2011-07-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with uncomplicated singleton pregnancies

Brief summary: This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in preterm and term pregnant patients.

Detailed description: The SureCALL® Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor intended to measure uterine activity. It is intended for use on pregnant women, with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting.

This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in pregnant laboring preterm patients, nonlaboring preterm patients, and nonlaboring term patients.

This study involved 25 women at a Gestational Age of 36 weeks or less and 5 women at a Gestation Age of greater than 36 at five clinical sites. Each study subject was instrumented with two technologies for measuring uterine activity:

1. Standard tocodynamometer attached to the maternal abdomen,
2. SureCALL® with a set of abdominal surface electrodes for uterine electromyography attached to the maternal abdomen

Subjects did not recieve any interventions as a part of this study.

Eligibility criteria: Inclusion Criteria:

* Singleton Pregnancy
* Informed Consent Required

Exclusion Criteria:

* Multifetal Pregnancy
* Informed Consent Not Given

Primary outcomes:
measure: Comparison of SureCALL® and Tocodynamometer Detection of Contraction Event Timing
timeFrame: 9 - 41 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Beaumont
country: United States
facility: Southeast Texas OB/GYN Associates
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Woman's Hospital of Texas
state: Texas
Study officials:
affiliation: Reproductive Research Technologies, LP
name: Timothy B Waterhouse, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01687829: Macular Hole Surgery With and Without Internal Limiting Membrane Peeling：A Systematic Review and Meta-analysis
Official title: Macular Hole Surgery With and Without Internal Limiting Membrane Peeling：A Systematic Review and Meta-analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Macular Holes
Keywords: Macular Holes
Internal limiting membrane
peeling
Surgery
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: Wenzhou Medical University
First posted: 2012-09-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients were scheduled to undergo macular hole surgery and randomized to with and without internal limiting membrane (ILM) peeling

Brief summary: Since Kelly and Wendel first reported successful closure of idiopathic macular holes (MH) by vitrectomy in 1991, many surgical modifications have been made to improve the anatomical and visual outcomes of this surgery. Recently, internal limiting membrane (ILM) peeling has become used widely as an adjunctive procedure during MH surgery because the removal of ILM is thought to reduce the tangential traction on the macula, a major factor in the pathogenesis of idiopathic macular holes. However, the role of ILM peeling in macular hole surgery is not yet well defined. To the best of our knowledge, there is no meta-analysis on comparison of the efficacy of ILM peeling and suture for MH surgery. This study reviewed the published literature comparing surgical results with and without ILM peeling and and performed a meta-analysis to determine whether there is any benefit or detriment anatomically and/or visually.


Eligibility criteria: Inclusion Criteria:

* Eligible participants are those with idiopathic FTMH in stages 2-3, of less or equal than 18 months duration (based on symptoms reported by the patient) and with a visual acuity equal to or worse than 20/40 in the study eye.

Exclusion Criteria:

* Patients with idiopathic FTMH stages 2-3 but longer than 18 months duration or with other causes of decreased vision (e.g. corneal scarring, age-related macular degeneration, diabetic retinopathy, glaucoma if central and/or paracentral absolute visual field defects are present) and
* Those with FTMH related to high myopia (\> 6 dioptres) or trauma will be excluded from the study.

Primary outcomes:
measure: Anatomic Success rate
timeFrame: 12 months
measure: Functional Success Rate
timeFrame: 12 month
Secondary outcomes:
measure: Best-corrected visual acuity
timeFrame: 12 month
measure: Complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: Yifan Feng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06314529: Long-term Follow-up Study of BHC001 for TDT
Official title: Long-term Follow-up Study of BHC001 in the Treatment of Transfusion-dependent β-thalassemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thalassemia, Beta
Lead sponsor: Bioray Laboratories
Sponsor class: INDUSTRY
Collaborators: name: The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army
name: Xiangya Hospital of Central South University
First posted: 2024-03-18
Enrollment: 6
Sex: ALL
Minimum age (years): 5
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with transfusion-dependent β-thalassemia who have been treated with BHC001.

Brief summary: Observe long-term safety risk and long-term efficacy after intravenous infusion of BHC001 in TDT subjects.

Detailed description: Observe long-term delayed safety risks such as emerging neoplasms, emerging haematological disorders, and long-term efficacy after intravenous infusion of BHC001 in TDT subjects.

Eligibility criteria: Inclusion Criteria:

1. Provision of written informed consent for this study by subjects, or as applicable, subject's parent(s)/legal guardian(s)
2. Treated with BRL-101 for therapy of transfusion-dependent β-thalassemia.

Exclusion Criteria:

- There are no exclusion criteria for this study

Primary outcomes:
measure: Incidence of hematologic malignancies
timeFrame: Up to 15 years post-drug product infusion
measure: Frequency, grade, and relationship of SAEs
timeFrame: Within 2 years to 5years after BRL-101 Infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Nanning
country: China
facility: The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army
state: Guangxi
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Bioray Laboratories
name: Xiaochen Wang, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06517329: Bullying Experiences Among Alexandria Faculty of Medicine Students
Official title: From Scrubs to Scars: Understanding Bullying Experiences Among Alexandria Faculty of Medicine Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bullying
Keywords: Bullying, Medical students, learning environment
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 565
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A non-probability sample from all medical students enrolled in undergraduate or graduate programs of Faculty of medicine, Alexandria University, Egypt

Brief summary: A cross-sectional study was conducted at Faculty of Medicine, Alexandria to study the prevalence, types and consequences of bullying among medical students. An online survey was distributed among medical students. The data collection continued for two academic years: 2021-2022 and 2022-2023.

Detailed description: A survey based Study was implemented. Questionnaire was used to collect sociodemographic data, exposure to different types if bullying, response and consequences of bullying

Eligibility criteria: Inclusion Criteria:

* medical students enrolled at undergraduate or graduate programs of Faculty of medicine who were exposed to bullying

Exclusion Criteria:

* medical students who were not exposed to hullying

Primary outcomes:
measure: Prevalence
timeFrame: 2021-2023
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine Alexandria University
Study officials:
affiliation: University of Alexandria
name: Hanaa S. Elhoshy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01586429: Ultrasound Guided Femoral Nerve Block Catheter Analgesia Compared With Epidural Analgesia for Patients With Knee OA (Osteoarthritis) Who Underwent Unilateral Total Knee Replacement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Keywords: comparing the analgesic efficacy of ultrasound-guided nerve block catheter compared with epidural analgesia
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2012-04-26
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: for patients with knee OA (osteoarthritis) who underwent unilateral total knee replacement.

Brief summary: Post-operative pain following total knee replacement can be disabling and sometimes lead to the need for prolonged hospital stay. Therefore development of improved post-operative modalities for total knee replacement surgery pain control is important. High-resolution ultrasound (US) allows accurate visualization of nerves and surrounding structures and can lead to higher success rates of nerve block. The investigators aim at comparing the analgesic efficacy of ultrasound-guided nerve block catheter compared with epidural analgesia for patients with knee OA who underwent unilateral total knee replacement.


Eligibility criteria: Inclusion Criteria:

* Male / female, Bilateral or unilateral knee OA (Osteoarthritis), and ASA (American Society of Anesthesiologist classification) 1 and 2.

Exclusion Criteria:

* Bilateral total knee replacement, Revision total knee replacement, previous knee surgery, Rheumatoid Arthritis, Avascular necrosis (AVN) knee, Post traumatic or post infectious OA, ASA3 and 4.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
state: Riyadh Region
city: Riyadh Region
country: Saudi Arabia
facility: King Saud University
Study officials:
References:
Clinical trial NCT04958629: A Prospective Cohort Study on Familial Hypercholesterolemia in Health Examination Population
Official title: A Prospective Cohort Study on Familial Hypercholesterolemia in Health Examination Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Familial Hypercholesterolemia
Keywords: familial hypercholesterolemia
prognosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 318
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: Patients with hyperlipidemia were screened from health examination population. Among the selected patients with hyperlipidemia, those who met the following inclusion and exclusion criteria were included in the study cohort as FH group or non-FH group.

Brief summary: To determine the prevalence and the prognosis in a corhort of patients with familial hypercholesterolemia (FH).

Detailed description: This study aims to achieve the following goals through prospective cohort study and statistical analysis: (1) to determine the prevalence of familial hypercholesterolemia (FH) in healthy people with hypercholesterolemia.（2) Compared with non FH population, the relative risk of atherosclerotic cardiovascular disease (ASCVD) in FH patients in China was calculated, and the risk prediction model of ASCVD in FH patients was constructed by using biochemical results, imaging data, biomarkers and other indicators.（3) To evaluate the benefits of different lipid-lowering strategies for FH patients in China.（4) To analyze the gene carriers of FH patients in China.

Eligibility criteria: Inclusion Criteria:

1) Patients with definite diagnosis of hyperlipidemia.

Exclusion Criteria:

1. Age \< 18.
2. Do not agree to participate in this study.
3. secondary hypercholesterolemia.
4. Phytosteronemia.

Primary outcomes:
measure: Number of participants with atherosclerotic cardiovascular disease (ASCVD) events
timeFrame: 2 years from enrollmet
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Wei Gao, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01650129: Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes
Official title: An Open-labelled, Randomised, Parallel Group, Multicentre, Safety and Efficacy Study of NN-X14Mix50 (BIAsp50) in a Twice Daily Regimen in Type 2 Diabetic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-07-26
Enrollment: 83
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of biphasic insulin aspart (BIAsp) 50 (NN-X14Mix50) compared with biphasic human insulin (BHI) 50 in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes
* Subjects with insulin treated for at least 24 weeks
* HbA1c maximum 11.0%
* Body mass index (BMI) below 30.0 kg/m\^2
* Patients who have the skill of self-injection of insulin, and are able and willing to perform self-monitoring blood glucose (SMBG) and are able to take measures against hypoglycaemic episodes

Exclusion Criteria:

* Recurrent severe hypoglycaemia
* Subjects with proliferative retinopathy or preproliferative retinopathy diagnosed within the last 12 weeks, or receiving photocoagulation therapy within the last one year
* Impaired hepatic function
* Impaired renal function
* Cardiac diseases
* Uncontrolled hypertension
* Subjects with history of severe allergic or severe hypersensitive reactions
* Total daily insulin dose at least 100 IU
* Treatment with oral hypoglycaemic agentsvwithin the last 4 weeks

Primary outcomes:
measure: Glycosylated haemoglobin A1c (HbA1c)
Secondary outcomes:
measure: Occurrence of adverse event(s)
measure: Blood glucose
measure: Incidence of hypoglycaemic episodes
measure: Change from baseline in insulin antibodies
measure: Insulin doses
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01239329: Malnutrition in People With Complex Multiple Disabilities
Official title: Understanding of Malnutrition in People With Complex Multiple Disabilities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complex Multiple Disabilities
Malnutrition
Keywords: Complex multiple disabilities
Malnutrition
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Stichting Pergamijn (Gouverneur Kremers Centrum/azM)
name: Koraalgroep(Gouverneur Kremers Centrum/azM)
name: Lunetzorg (Gouverneur Kremers Centrum/azM)
First posted: 2010-11-11
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 125 people with complex multiple disabilities, living in a care institution participating in the Governor Kremers Centre (GKC).

Brief summary: Underweight is more prevalent in people with a mental handicap than in people without a mental handicap, especially in people with a severe mental handicap. It is unknown if these people are malnourished. There is no validated screening instrument available to determine the nutrition status in people with complex multiple disabilities. Research regarding malnutrition based on body composition and nutrients in stead of anthropometric data is important.

The aim of the study is to understand the nutritional status of people with complex multiple disabilitiest through measurement of body composition and nutritients. The primary objective of the study is: What percentage of people with complex multiple disabilities are malnourished, based on altered body composition and nutritients? Understanding the nutritional status of these patients is important in order for them to receive appropriate and effective treatment. This treatment is of interest for general health and the quality of daily life.


Eligibility criteria: Inclusion Criteria:

* Person with complex multiple disabilities;
* Living in a care institution participating in the Governor Kremers Centre (GKC);
* Chronically confined to a wheelchair or bedridden;
* 18+ years

Exclusion Criteria:

* Parenteral nutrition;
* Serious infection;
* Terminal illness

Primary outcomes:
measure: What percentage of people with complex multiple disabilities are malnourished, based on altered body composition and nutritients?
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Leopold MG Curfs, Professor
role: STUDY_DIRECTOR
affiliation: Maastricht University Medical Center
name: Eric EJ Smeets, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03104829: DSME or DSME + MI in T1DM on Glycemic Control
Official title: A Randomized Control Trial Compare Between Diabetic Knowledge and Self-care Behaviors (DSME) With and Without Motivational Interviewing, on Glycemic Control Among Children and Adolescents With Diabetes Mellitus Type 1
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of diabetic knowledge and self care behavior (DSME) alone or DSME plus motivational interviewing on glycemic control among children and adolescents with DM type 1. Half of participants will receive DSME along, while the other half will receive DSME plus MI.


Eligibility criteria: Inclusion Criteria:

* T1DM
* age more than 10 years old
* HbA1C more than 8%

Exclusion Criteria:

* other types of DM
* receive medications that may effect blood glucose
* mental retardation

Primary outcomes:
measure: HbA1C
timeFrame: at the beginning of the study, 3 month and 6 months later
Secondary outcomes:
measure: Pre and post test scores for Diabetic knowledge
timeFrame: at the beginning and 6 months later
measure: Diabetic self-care behavior score
timeFrame: at the beginning and 6 months later
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Ornsuda Lertbannaphong
state: Bangkok
Study officials:
affiliation: Endocrinology Division, Pediatrics department, Siriraj Hospital
name: Ornsuda Lertbannaphong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Santiprabhob J, Likitmaskul S, Kiattisakthavee P, Weerakulwattana P, Chaichanwattanakul K, Nakavachara P, Peerapatdit T, Nitiyanant W. Glycemic control and the psychosocial benefits gained by patients with type 1 diabetes mellitus attending the diabetes camp. Patient Educ Couns. 2008 Oct;73(1):60-6. doi: 10.1016/j.pec.2008.05.023. Epub 2008 Jul 7.
citation: Viner RM, Christie D, Taylor V, Hey S. Motivational/solution-focused intervention improves HbA1c in adolescents with Type 1 diabetes: a pilot study. Diabet Med. 2003 Sep;20(9):739-42. doi: 10.1046/j.1464-5491.2003.00995.x.