louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02148861: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes
Official title: A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Type 2 Diabetes Mellitus
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-05-28
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of subcutaneously administered NNC0148-0287 (insulin 287) in subjects with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* Male or female, age between 18 and 64 years (both inclusive) at the time of signing informed consent
* Females of no childbearing potential \[if surgically sterilized (i.e. tubal ligation, bilateral oophorectomises or hysterectomised) for at least 3 months or if post-menopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by FSH (follicle-stimulating hormone) levels above 40 U/L\]
* Body mass index (BMI) between 20.0 and 35.0 kg/m\^2 (both inclusive)
* Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Receipt of any investigational medicinal products within 3 months before screening
* Use of oral antidiabetic drugs (OADs) or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening

Primary outcomes:
measure: Number of treatment emergent adverse events
timeFrame: From the first trial product administration at Day 1 until completion of the post-treatment follow-up visit (3-14 days after Visit 9, Day 65)
Secondary outcomes:
measure: Area under the steady-state serum insulin 287 concentration-time curve
timeFrame: During one dosing interval at steady-state from 0 to 168 h after last dose (Day 29)
measure: area under the glucose infusion rate - time curve at steady-state
timeFrame: At Day 31 and day 35
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00184561: Effectiveness and Safety of Biphasic Insulin Aspart 70/30 in Subjects With Type 2 Diabetes
Official title: Change in HbA1c With Biphasic Insulin Aspart 70/30 in Two Different Treatment Regiments in Subjects With Type 2 Diabetes Inadequately Controlled With Oral Anti-diabetic Drug Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. This is a clinical trial investigating the effectiveness of using Biphasic Insulin Aspart 70/30 in two different treatment regiments for 6 months in subjects with type 2 diabetes, not well controlled on their current oral anti-diabetic drug therapy.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* HbA1C = 7.5%
* Insulin naïve
* Current treatment by Oral Anti-diabetic Drugs

Exclusion Criteria:

* Severe medical conditions

Primary outcomes:
measure: Change in HbA1c
timeFrame: After 24 weeks of treatment
Secondary outcomes:
measure: Adverse events
measure: Weight change
measure: Fasting blood glucose
measure: Hypoglycaemic episodes
measure: 2-hour postprandial blood glucose
measure: after 24 weeks of treatment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Guangzhou
country: China
facility: Novo Nordisk Investigational Site
state: Guangdong
city: Wuhan
country: China
facility: Novo Nordisk Investigational Site
state: Hubei
city: Nanjing
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Xi'an
country: China
facility: Novo Nordisk Investigational Site
state: Shaanxi
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Tianjin
country: China
facility: Novo Nordisk Investigational Site
state: Tianjin
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Yang W, Ji Q, Zhu D, Yang J, Chen L, Liu Z, Yu D, Yan L. Biphasic insulin aspart 30 three times daily is more effective than a twice-daily regimen, without increasing hypoglycemia, in Chinese subjects with type 2 diabetes inadequately controlled on oral antidiabetes drugs. Diabetes Care. 2008 May;31(5):852-6. doi: 10.2337/dc07-1992. Epub 2008 Feb 11.
Clinical trial NCT01385761: LMA Unique TM & the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children
Official title: A Prospective, Randomized Non- Crossover Investigation of the LMA Unique TM and the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children
Keywords: Supraglottic airway devices
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2011-06-30
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children weighing 20 to 30 kg undergoing surgery requiring a supraglottic airway device

Brief summary: The purpose of this study is to compare the clinical efficacy of the air-Q ILA-SP with the current standard of care, the LMA Unique in anesthetized non-paralyzed pediatric patients.

Detailed description: The goal for this randomized, non-crossover investigation is to compare a disposable version of the standard LMA, LMA Unique TM,with the air-Q ILA-SP in pediatric patients. Oropharyngeal leak pressure is commonly used as an indicator of airway seal adequacy. Similarly, flexible fiberoptic bronchoscope examination is often employed to assess proper placement of airway devices. We hypothesize that airway leak pressures with the ILA-SP will be superior to the LMA upon initial device placement, and ten minutes after device placement. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. Ease of placement, fiberoptic grade of laryngeal view, and complications (airway related, gastric insufflation, trauma) will also be assessed.

Eligibility criteria: Inclusion Criteria:

* Children undergoing general anesthesia using a supraglottic airway device
* 3 to 9 years of age
* 20 to 30 kilograms in weight

Exclusion Criteria:

* History of a difficult airway
* Active gastrointestinal reflux
* Active upper respiratory tract infection

Primary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Childrens Memorial Hospital
state: Illinois
Study officials:
affiliation: Childrens Memorial Hospital
name: Narasimhan Jagannathan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jagannathan N, Sohn LE, Mankoo R, Langen KE, Roth AG, Hall SC. Prospective evaluation of the self-pressurized air-Q intubating laryngeal airway in children. Paediatr Anaesth. 2011 Jun;21(6):673-80. doi: 10.1111/j.1460-9592.2011.03576.x.
citation: Shimbori H, Ono K, Miwa T, Morimura N, Noguchi M, Hiroki K. Comparison of the LMA-ProSeal and LMA-Classic in children. Br J Anaesth. 2004 Oct;93(4):528-31. doi: 10.1093/bja/aeh238. Epub 2004 Aug 6.
citation: White MC, Cook TM, Stoddart PA. A critique of elective pediatric supraglottic airway devices. Paediatr Anaesth. 2009 Jul;19 Suppl 1:55-65. doi: 10.1111/j.1460-9592.2009.02997.x.
Clinical trial NCT00985361: Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus
Official title: Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: ProMedica Health System
Sponsor class: OTHER
First posted: 2009-09-28
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if daily supplementation with 2000 International Units of Vitamin D will improve hemoglobin A1c in uncontrolled type 2 diabetics.

Detailed description: Vitamin D is typically understood to support musculoskeletal health when administered concomitantly with calcium. A number of recent studies suggest, however, that this important nutrient may play a significant role in many pathophysiological processes, including diabetes mellitus. With the prevalence of diabetes mellitus ever increasing, novel mechanisms for controlling blood glucose and hemoglobin A1c are being sought to help prevent the costly and debilitating complications of this chronic disease.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Hemoglobin A1c \>7% measured in the 3 months prior to randomization
* Age 21 to 75 years

Exclusion Criteria:

* Renal insufficiency (defined as CrCl \<30mL/min)
* Gestational diabetes
* Malabsorption syndrome
* Patients taking vitamin D supplements at doses \>400 international units daily

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sylvania
country: United States
facility: Flower Hospital Family Medicine Residency
state: Ohio
city: Toledo
country: United States
facility: Center for Health Services
state: Ohio
city: Toledo
country: United States
facility: Toledo Hospital Family Medicine Residency
state: Ohio
Study officials:
affiliation: ProMedica Health System
name: Mate M Soric, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soric MM, Renner ET, Smith SR. Effect of daily vitamin D supplementation on HbA1c in patients with uncontrolled type 2 diabetes mellitus: a pilot study. J Diabetes. 2012 Mar;4(1):104-5. doi: 10.1111/j.1753-0407.2011.00164.x. No abstract available.
Clinical trial NCT01727661: Cardiopulmonary Fitness, Lung Function, Muscular Oxygen Saturation, and Quality of Life in T1DM
Official title: Cardiopulmonary Fitness, Lung Function, Muscular Oxygen Saturation, and Quality of Life in Patients With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: diabetes mellitus
cardiopulmonary fitness
lung function
muscular oxygenation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatient department

Brief summary: The purpose of this study is to compare the differences of

1. cardiopulmonary fitness
2. lung function
3. muscular oxygen saturation
4. quality of life between type 1 diabetes mellitus and healthy adults.

Detailed description: This study is also to investigate the relationships between cardiopulmonary fitness, lung function, muscular oxygen saturation, glycemic control, and quality of life in patients with type 1 diabetes mellitus.

Eligibility criteria: Inclusion Criteria:

* diagnosis of type 1 diabetes mellitus ≥2 years (diabetic group)
* age-, gender-, and BMI-matched healthy subjects (control group)

Exclusion Criteria:

* cardiac or respiratory disease
* pregnancy
* hospitalization due to any medical condition in recent 6 months
* any other condition affecting exercise performance or lung function.

Primary outcomes:
measure: exercise testing with near-infrared spectroscopy
timeFrame: at baseline
Secondary outcomes:
measure: lung function
timeFrame: at baseline
measure: quality of life
timeFrame: at baseline
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ying-Tai Wu, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wanke T, Formanek D, Auinger M, Zwick H, Irsigler K. Pulmonary gas exchange and oxygen uptake during exercise in patients with type 1 diabetes mellitus. Diabet Med. 1992 Apr;9(3):252-7. doi: 10.1111/j.1464-5491.1992.tb01771.x.
citation: Komatsu WR, Barros Neto TL, Chacra AR, Dib SA. Aerobic exercise capacity and pulmonary function in athletes with and without type 1 diabetes. Diabetes Care. 2010 Dec;33(12):2555-7. doi: 10.2337/dc10-0769. Epub 2010 Aug 31.
Clinical trial NCT00860561: Faslodex Post Marketing Surveillance
Official title: Faslodex Post Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Efficacy profile
Safety profile
Faslodex
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-12
Enrollment: 42
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal women with locally advanced or metastatic breast cancer who have failed 2 or more prior hormone therapies, or were intolerant to prior hormone therapy and have no endocrine therapeutic options.

Brief summary: This PMS aims to assess the efficacy, the safety and tolerability profile of Faslodex in everyday practice. Secondary objective of this PMS is to identify the frequency of serious adverse events or any unknown adverse events of Faslodex.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women
* Patients who have failed 2 or more prior hormone therapies (The prior hormone therapies should contain both antiestrogen and non-steroidal Aromatase inhibitor)
* Patients who were intolerant to prior hormone therapy and have no endocrine therapeutic options (The prior hormone therapies should contain both antiestrogen and non-steroidal Aromatase inhibitor)

Exclusion Criteria:

* The patients who received Faslodex treatment before

Primary outcomes:
measure: Adverse events are confirmed by investigator through asking to patients or patients' voluntary reporting.
timeFrame: 5 years
measure: Efficacy of Faslodex is assessed by proper method among CT scan, MRI, Ultrasound, etc. The RECIST criteria for target and non-target lesions will be used to evaluate efficacy.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Iksan
country: Korea, Republic of
facility: Research Site
city: Jeonju
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon-si
country: Korea, Republic of
facility: Research Site
Study officials:
References:
Clinical trial NCT04133961: Intraoperative Phenylephrine Infusion to Reduce Postoperative Shivering in Lower Segment Caesarean Section
Official title: Intraoperative Phenylephrine Infusion to Reduce Postoperative Shivering in Lower Segment Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Shivering
Keywords: Phenylephrine
Spinal anaesthesia
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Assessment of whether and how phenylephrine infusion reduces postoperative shivering in spinal anaesthesia.

Detailed description: This study aims to evaluate whether phenylephrine infusion can reduce postoperative shivering among patients scheduled for elective lower segment caesarean section under spinal anaesthesia.

Eligibility criteria: Inclusion Criteria:

* More than 18 years of age
* American Society of Anesthesiologists (ASA) II patients
* Patients with singleton pregnancy who are scheduled to undergo elective lower segment caesarean section under spinal anaesthesia

Exclusion Criteria:

* Patients with contraindication to phenylephrine
* Patients with evidence of fever or infection, or hypothermia preoperatively
* BMI ≥ 40
* Height \<150cm

Primary outcomes:
measure: Presence and intensity of shivering
timeFrame: 2 hours
Secondary outcomes:
measure: Change in patient's core and skin temperature
timeFrame: 2 hours
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Pusat Perubatan Universiti Kebangsaan Malaysia
Study officials:
affiliation: Anaesthesiologist
name: Syarifah Noor Nazihah Sayed Masri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ikeda T, Ozaki M, Sessler DI, Kazama T, Ikeda K, Sato S. Intraoperative phenylephrine infusion decreases the magnitude of redistribution hypothermia. Anesth Analg. 1999 Aug;89(2):462-5. doi: 10.1097/00000539-199908000-00040.
citation: Ro Y, Huh J, Min S, Han S, Hwang J, Yang S, Kim DK, Kim C. Phenylephrine attenuates intra-operative hypothermia during spinal anaesthesia. J Int Med Res. 2009 Nov-Dec;37(6):1701-8. doi: 10.1177/147323000903700605.
citation: Hilton EJ, Wilson SH, Wolf BJ, Hand W, Roberts L, Hebbar L. Effect of Intraoperative Phenylephrine Infusion on Redistribution Hypothermia During Cesarean Delivery Under Spinal Anesthesia. J Clin Anesth Manag. 2016 Jan;1(1):10.16966/2470-9956.103. doi: 10.16966/2470-9956.103. Epub 2015 Dec 19.
citation: Badjatia N, Strongilis E, Gordon E, Prescutti M, Fernandez L, Fernandez A, Buitrago M, Schmidt JM, Ostapkovich ND, Mayer SA. Metabolic impact of shivering during therapeutic temperature modulation: the Bedside Shivering Assessment Scale. Stroke. 2008 Dec;39(12):3242-7. doi: 10.1161/STROKEAHA.108.523654. Epub 2008 Oct 16.
Clinical trial NCT00885261: The Prevalence of Metabolic Syndrome in Patients Suffering From Chronic Pain
Official title: The Prevalence of Metabolic Syndrome in Patients Suffering From Chronic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain and Metabolic Syndrome
Keywords: chronic pain and metabolic syndrome
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-04-21
Enrollment: 100
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 over 18 that suffer from chronic pain and are being treated at the pain medicine unit

Brief summary: Obesity is considered as the epidemic of the century. Central obesity is one of the metabolic syndrome's features. It has been proven that obesity can cause back pain and headaches; thus, there might be a link between chronic pain and the syndrome.

The objective of this study is to assess the prevalence of metabolic syndrome in patients suffering from chronic pain.

Detailed description: All patients will answer a questionnaire, their hip circumference will be measured, and their BMI will be calculated (weight/(height)2 ).

The patients' blood pressure will be measured. The patients will be asked to bring their blood tests (lipids and glucose).

Eligibility criteria: Inclusion Criteria:

* Patients over 18 that suffer from chronic pain and are being treated at the pain medicine unit

Exclusion Criteria:

* Pregnant women, patients with abdominal wall defects

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Pain Medicine Unit
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Silviu Brill, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01060761: Involvement of Patients and Relatives in the Course of Cancer Disease
Official title: Involvement of Patients and Relatives in the Course of Cancer Disease With a Particular View to Rehabilitation and the Life With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Cancer
Relatives
Keywords: cancer
Rehabilitation program (patient and a relative together)
counselling
retreat weekend
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2010-02-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective is to investigate a rehabilitation program (supportive conversations and a rehabilitation course for cancer patients and their relatives together).

The study evaluate the effect of the program compared to no intervention (usual care)

Detailed description: The study aim to evaluate the effect and the benefit of the program.

First the patients psychosocial well-being is assessed in a survey (EORTC, POMS, WHO-5 well-being index) Then their relatives psychosocial well-being is assessed in a survey (Ad hoc questions, POMS and WHO-5 well-being index)

The effect is also assessed in qualitative interviews with patients and their relatives.

The rehabilitation course is investigated in qualitative observations and interviews.

Eligibility criteria: Inclusion Criteria:

* Both the patient and their relative must agree to participate together
* Patient admitted to the Hospital
* Patient admitted with a lung cancer diagnosis or
* Patient admitted with a gynecological cancer diagnosis

Exclusion Criteria:

* The cancer diagnosis was not verified.

Primary outcomes:
measure: Quality of life,
timeFrame: two months and one year
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: University of Southern Denmark
name: Helle P Hansen, Professor
role: PRINCIPAL_INVESTIGATOR
References: