louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06356454: Knowledge, Attitudes and Practices of Paediatric Cardiologists About Cardiac Rehabilitation in Children With Congenital Heart Disease
Official title: Knowledge, Attitudes and Practices of Paediatric Cardiologists About Cardiac Rehabilitation in Children With Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Physician's Role
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 32
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of the study is paediatric cardiologists. The sample consists of paediatric cardiologists who volunteered to participate in the study, to whom the study could be announced/notified, and who actively serve in patient diagnosis and treatment.

Brief summary: Despite significant clinical benefits and recommendations of clinical practice guidelines to refer patients for exercise and physical activity counselling in the capacity of cardiac rehabilitation (CR), CR is largely underutilised and not implemented effectively. Studies have reported that the reasons for the low implementation of CR are multifactorial at the healthcare system, physician and patient levels. Therefore, the aim of this study was to investigate the knowledge, attitudes and practical applications of paediatric cardiologists regarding cardiac rehabilitation and specifically exercise and physical activity in children with congenital heart disease (CHD).


Eligibility criteria: Inclusion Criteria:

* To be a paediatric cardiologist,
* Providing active service in patient diagnosis and treatment

Exclusion Criteria:

* Not providing active service in patient diagnosis and treatment despite being a paediatric cardiologist (administrative position, etc.).

Primary outcomes:
measure: The score of Questionnaire on knowledge, attitudes and practices of paediatric cardiologists about cardiac rehabilitation in children with congenital heart disease
timeFrame: 10-15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01738854: The Comparison of Airway Sealing With the Laryngeal Mask Airway (LMA) Supreme at Different Intracuff Pressure in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Keywords: laryngeal mask airway supreme
airway sealing
intracuff pressure
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 36
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The laryngeal mask airway (LMA) supreme is a relatively new single-use supraglottic airway with modification. The parameters about airway sealing such as oropharyngeal leak pressure (OLP) and leakage volume are important markers of efficacy and safety when using the supraglottic airway. The airway sealing is related to the intracuff pressure of laryngeal mask airway. The aim of this study is to compare the airway sealing of the LMA supreme at various intracuff pressure in children.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients (less than 108months of age)
* scheduled for elective surgery undergoing general anesthesia using LMA supreme 1.5-2.5

Exclusion Criteria:

* Patients with an abnormal airway,
* reactive airway disease,
* gastroesophageal reflux disease,
* chronic respiratory disease,
* a history of an upper respiratory tract infection

Primary outcomes:
measure: The oropharyngeal leak pressure volume
timeFrame: approximately 5 minutes after adjusting intracuff pressure
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
citation: Zhang L, Seet E, Mehta V, Subramanyam R, Ankichetty SP, Wong DT, Chung F. Oropharyngeal leak pressure with the laryngeal mask airway Supreme at different intracuff pressures: a randomized controlled trial. Can J Anaesth. 2011 Jul;58(7):624-629. doi: 10.1007/s12630-011-9514-6. Epub 2011 Apr 30.
Clinical trial NCT01513954: Examination of Serum Progesterone Levels in an IVF Population Following Two Types of Egg Aspiration
Official title: Examination of Serum Progesterone Levels in an IVF Population Following Two Types of Egg Aspiration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Female
Keywords: Infertility
Lead sponsor: Red Rock Fertility Center
Sponsor class: OTHER
Collaborators: name: Watson Pharmaceuticals
First posted: 2012-01-20
Enrollment: 450
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IUI patients and IVF patients following a long lupron protocol cycle

Brief summary: The purpose of this study is to determine whether progesterone hormone levels differ following egg retrieval with a single lumen needle compared with a double lumen needle. These levels will be measured on several days before and after egg retrieval. The progesterone levels in each IVF group will also be compared to the group of women who are having IUI. In addition, these progesterone levels will be correlated with pregnancy outcomes.

Detailed description: This is a prospective randomized trial consisting of 3 groups of patients. Following a long lupron protocol IVF cycle there is a need for supplemental progesterone. The purpose of this study is to determine what range of serum levels should be observed when differing methods of egg aspiration have been administered and whether or not there is a correlation with outcomes or pregnancies.

Eligibility criteria: Inclusion Criteria:

* Ages between 21-37
* Cycle Day 3 FSH between 2-12
* History of regular menstrual cycles between 24-34 days

Exclusion Criteria:

* Previous IVF failure
* Severe male factor
* Severe obesity, BMI \> 40
* More than 20 follicles on ultrasound prior to retrieval

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Red Rock Fertility Center
state: Nevada
Study officials:
affiliation: Red Rock Fertility Center
name: Eva D Littman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00845754: Post-Operative Treatment With Ketorolac After Abdominal Myomectomy
Official title: Effects of Ketorolac on Post-Operative Febrile Morbidity and Pain Management in Abdominal Myomectomy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Febrile Morbidity
Pain
Keywords: Post-operative febrile morbidity
Post-operative pain management
Lead sponsor: Ascher-Walsh, Charles, M.D.
Sponsor class: INDIV
Collaborators: name: New York Presbyterian Hospital
name: Icahn School of Medicine at Mount Sinai
First posted: 2009-02-18
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if ketorolac, given after abdominal myomectomy, will decrease the frequency of post-oerative fevers as well as improve post-operative pain management.


Eligibility criteria: Inclusion Criteria:

* Ant patient undregoing abdominal myomectomy

Exclusion Criteria:

* Patients with contraindication to NSAIDs including history of peptic ulcer disease, renal disease, bleeding diathesis, or hypersensitivity to NSAIDS

Primary outcomes:
measure: Post-operative febrile morbidity
timeFrame: Inital 24hrs post-operative
Secondary outcomes:
measure: Post-operative pain management
timeFrame: Initial 24hrs post-operative
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
References:
Clinical trial NCT01206933: The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System
Official title: The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus (HIV)
Hepatitis C, Chronic
Keywords: HIV/HCV Coinfection
Tat Protein
HCV
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2010-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Four groups of subjects will be included in this study, with 5 participants in each group:

1. detectable HIV RNA (Ribonucleic Acid) and detectable HCV RNA
2. undetectable HIV RNA (treated) and detectable HCV RNA
3. undetectable HIV RNA (treated) and undetectable HCV RNA
4. undetectable HCV RNA (mono-infected)
5. detectable HCV RNA (mono-infected)
6. detectable HIV RNA (mono-infected)

Brief summary: Investigators in the Division of Infectious Diseases and the Departments of Biochemistry and Molecular Biology of The George Washington University Medical Center are carrying out a research study to determine why patients with Human Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV) co-infection (HIV/HCV) have a more rapid and progressive course of HCV infection, leading to fatty infiltration of the liver and cirrhosis.

Detailed description: Samples will be collected from 4 groups of patients with HIV/HCV infection, identified by the virologic control of either HIV, HCV, or both. Sera will be used in an in-vitro hepatocyte model of hepatitis C infection to better understand the pathogenesis of HIV/HCV co-infection, and to gain insight into intracellular mechanisms.

Eligibility criteria: Inclusion Criteria:

* Meets one of the following criteria:

  1. detectable HIV RNA and detectable HCV RNA
  2. undetectable HIV RNA (treated) and detectable HCV RNA
  3. undetectable HIV RNA (treated) and undetectable HCV RNA
  4. undetectable HCV RNA (mono-infected)
  5. detectable HCV RNA (mono-infected)
  6. detectable HIV RNA (mono-infected)

Participants will be men and women, ages 18 and older, and who are patients being seen in the clinics of the Medical Faculty Associates, and meet the above criteria.

Exclusion Criteria:

* None

Primary outcomes:
measure: Laboratory analysis of Tat Protein
timeFrame: Single sample analysis
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
Study officials:
affiliation: George Washington University
name: David Parenti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00391833: Effect of Panax Ginseng on the Cognitive Performance in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alzheimer's Disease
Memory Decline
Keywords: Alzheimer's disease, Ginseng, CD34
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2006-10-24
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We investigate the clinical efficacy of Panax ginseng in Alzheimer's disease (AD).

Detailed description: Alzheimer's disease (AD) is characterized by a progressive decline of memory and intellectual abilities, interfering activity in daily living, the overall quality of life, and ultimately leads to death. Although pharmacologic treatments are currently approved for treating mild- to moderate AD using acetylcholinesterase inhibitors (ACEI) or memantine, the NMDA antagonist, for the advanced stage of AD, the therapeutic efficacies need to be further improved.

For millennia, ginseng or its components have been used to treat medical conditions, and the pharmacologic effects have been demonstrated in cardiovascular, endocrine and immune system (Attele et al., 1999). In means of memory and learning, a number of studies suggested that ginseng can attenuate learning deficits of damaged or ageing brains in rodent models (Kennedy et al., 2003; Zhao and McDaniel, 1998; Nitta et al., 1995). In studies with human healthy participants, correspondently, both acute and chronic dosage of ginseng increased the cognitive performance (Kennedy et al., 2001; Kennedy et al., 2003; D'Angelo et al., 1986; Sorensen and Sonne, 1996).

In this study, we we will investigate the contribution of ginseng treatment in increasing the cognitive improvement of AD patients. In addition, we will test various bio-markers and hematopoietic progenitor cell count in those included patients using their blood samples. Patients with AD as well as memory decline will be included

Eligibility criteria: Inclusion Criteria:

* Alzheimer's disease

Exclusion Criteria:

* other neurologic disease

Primary outcomes:
measure: Cognitive performances monitored by MMSE and Alzheimer's disease assessment scales.
measure: Biomarkers including hematopoietic progenitor cell count.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Neurology, Seoul National University Hospital
name: Manho Kim, MD, PhD
role: STUDY_CHAIR
References:
citation: Lee ST, Chu K, Sim JY, Heo JH, Kim M. Panax ginseng enhances cognitive performance in Alzheimer disease. Alzheimer Dis Assoc Disord. 2008 Jul-Sep;22(3):222-6. doi: 10.1097/WAD.0b013e31816c92e6.
Clinical trial NCT01461733: Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit
Official title: Atrial Fibrillation WITHOUT Hemodynamic Stability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
amiodarone
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2011-10-28
Enrollment: 25
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: Atrial fibrillation (AF) is an abnormal heart rhythm that is common among patients who are admitted to an intensive care unit (ICU) of a hospital. It is usually a transient occurrence that resolves as the patient recovers from their underlying condition. However, patients who develop AF can present with a very rapid heart rate that in some cases can put stress on the heart which can lead to life threatening heart attacks, low blood pressure or breathing problems. Not all patients with AF will have unstable heart function but those who have rapid heart rates can worsen quickly. The goals of treatment for AF with a rapid heart rate but no unstable heart function are two fold. Patients can be treated by controlling the heart rate and/or by attempting to convert the AF to a normal heart rhythm. The heart rate can be controlled by medication and the AF can be converted by either electrical cardioversion (an electric shock that jump-starts the heart) or medication. Currently it is unknown if the goal of treatment should be to simply control the heart rate and wait for the patient to spontaneously convert to a normal heart rhythm or convert the AF with medication for patients who only have the rapid heart rate.

The objective of this project is to conduct a pilot study to determine if it would be feasible to conduct a larger definitive trial that would answer the following question: Should the goal of treatment be to control the rapid heart rate or resolve the abnormal heart rhythm in patients with AF who have a rapid heart rate without unstable heart function.

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* new onset afib

Exclusion Criteria:

* hemodynamically unstable

Primary outcomes:
measure: Conversion From Atrial Fibrillation to Sinus Rhythm
timeFrame: From randomization to conversion or ICU discharge up to 100 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Salmaan Kanji, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06019533: A Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles
Official title: A Multicentre, Single Arm Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Insud Pharma
Sponsor class: INDUSTRY
First posted: 2023-08-31
Enrollment: 750
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Multicentre, single arm phase III trial to assess the pearl index of LVDS. The trial lasts 13 cycles.The assessments include (but are not limited to) recording demographic data, pregnancy tests, gynaecological examinations, laboratory tests and a quality of life questionnaire. Adolescents will undergo DXA scans to measure bone mineral density (at selected sites only). The women will be provided with an e-diary app for their smartphone, to record IP use and vaginal bleeding.


Eligibility criteria: Inclusion Criteria:

* At Visit 1a, subjects must meet ALL of the following criteria:

  1. Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy including breastfeeding women.
  2. Women who either

     1. have never used hormonal contraceptives before consent/assent (naïve users), or
     2. have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent/assent and a full menstrual cycle during the drug-free period (previous users) or
     3. directly switch from another hormonal contraceptive (switchers).
  3. Only for subjects who were not pregnant and did not use hormonal contraception during the last 6 months before consent/assent:

Regular cycles (i.e. cycle length between 24 and 35 days) during the last 6 months.

Exclusion Criteria:

1. Pregnancy or wish of pregnancy.
2. Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary.
3. History of infertility.
4. Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a.
5. Unexplained amenorrhoea.
6. Abnormal finding on pelvic, breast or ultrasound examination that in the investigator's opinion contraindicates participation in the trial.

Primary outcomes:
measure: Pearl Index
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Móstoles
country: Spain
facility: LR-301/
state: Madrid
Study officials:
References:
Clinical trial NCT02921633: Childhood Influenza Immunisation in General Practice Invitation Trial
Official title: Can Uptake of Childhood Influenza Immunisation in GP Practices be Increased Through Behavioural-insight Informed Changes to the Invitation Process?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza, Human
Keywords: Immunization
Behavioural insights
Children
Lead sponsor: Public Health England
Sponsor class: OTHER_GOV
Collaborators: name: National Health Service, United Kingdom
First posted: 2016-10-03
Enrollment: 21786
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will investigate whether behaviourally informed changes to the invitation process can improve uptake of childhood influenza vaccine by two and three year olds at primary care.

Detailed description: Previous research has shown that small changes to routine invitations/reminders to attend local health services informed by behavioural science can be used to increase a desired behaviour (e.g. uptake of health checks, reducing missed appointments).

This trial will determine whether an invitation letter, informed by behavioural insights and sent through a central system (Child Health Information System, CHIS), can increase uptake of childhood flu vaccine in primary care.

The trial will take place within the existing national childhood immunisation programme in the participating area in England. Randomisation will be clustered at the primary care practice level. Outcome data will be anonymised, routinely collected, individual-level influenza vaccine uptake data extracted from CHIS. For CHIS data validation purposes, practice-level vaccine uptake data reported through an alternative, routine system will be collected. Data will be collected on additional invitations/communications that primary care practices (in both the intervention and control arms) send to their patients. Cost data for the centralised letter will also be obtained.

The analysis will investigate the main effect of the intervention on uptake of the flu vaccination for all eligible children included in the trial. The model will include primary care practice and Clinical Commissioning Group effects to account for clustering. Secondary analysis will investigate the impact of such individual factors as age, immunisation history and socioeconomic status and practice-level factors (e.g. direct communication from practices) on uptake of the flu vaccination.

Eligibility criteria: Inclusion Criteria:

* 2 years or 3 year olds at 31st August 2016
* Registered with a primary care practice in the participating area

Primary outcomes:
measure: Influenza immunisation uptake
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Public Health England
name: Tim Chadborn, BSc MSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00597233: Human Insulin NPH and Insulin Aspart in Type 1 Diabetes
Official title: Comparative Evaluation of Human NPH Insulin + Insulin Aspart and Human NPH Insulin + Human Soluble Insulin in Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-01-18
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in South America. This aim of this trial is to evaluate the comparative prandial blood glucose lowering profile in subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Treatment with insulin NPH
* Body Mass Index (BMI) below 30 kg/m2

Exclusion Criteria:

* Total daily insulin dose greater than 1.40 IU/kg
* Treatment with oral antidiabetic drugs (OADs)

Primary outcomes:
measure: Prandial blood glucose lowering profile
timeFrame: between 1st and 2nd post prandial hours
Secondary outcomes:
measure: Hypoglycaemic events
measure: Adverse events
measure: Serious adverse events
Other outcomes:
Locations:
city: Junin
country: Argentina
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Cintora H, Rodrigues M, Klyver MI, Claus-Hermerg H, González G, Kanevsky D, Medrano G, Sánchez A. Insulina Aspártica versus insulina soluble humana: Estudio comparativo cruzado en pacientes con diabetes tipo 1. Revista de la Sociedad Argentina de Diabetes 2004; 38 (4): 218-224