louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00775736: Observational Study Evaluating the Safety of NovoMix® in Type 2 Diabetes Patients Previously Treated With a Human Premix Insulin
Official title: Observational Study Evaluating Safety in Patients With Type 2 Diabetes Treated With NovoMix® 30 or NovoMix® 50 or NovoMix®70 (Biphasic Insulin Aspart)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-10-20
Enrollment: 611
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: After the participating physicians' decision has been made to initiate NovoMix® therapy, any patient with type 2 diabetes who is currently treated with a human premix insulin therapy.

Brief summary: This study is conducted in Europe. The objective of this observational study is to evaluate the number of serious side effects, when initiating NovoMix® treatment in patients with type 2 diabetes who previously used a human premix insulin under normal clinical practice


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus

Exclusion Criteria:

* Known or suspected allergy to study product or related products.
* Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months.

Primary outcomes:
measure: The number of serious adverse drug reactions, including major hypoglycaemic episodes, reported during the study period.
timeFrame: At baseline, 12 and 26 weeks.
Secondary outcomes:
measure: Number of all hypoglycaemic episodes.
timeFrame: At baseline, 12 and 26 weeks.
measure: Number of all adverse drug reactions.
timeFrame: At baseline, 12 and 26 weeks.
measure: HbA1c
timeFrame: at 12 and 26 weeks
measure: Evaluation of fasting plasma glucose (FPG) values and postprandial glucose (PPG) levels
timeFrame: at 12 and 26 weeks
measure: Weight changes
timeFrame: at 12 and 26 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Novo Nordisk Investigational Site
city: Luxembourg
country: Luxembourg
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Nobels F, D'Hooge D, Crenier L. Switching to biphasic insulin aspart 30/50/70 from biphasic human insulin 30/50 in patients with type 2 diabetes in normal clinical practice: observational study results. Curr Med Res Opin. 2012 Jun;28(6):1017-26. doi: 10.1185/03007995.2012.695730. Epub 2012 Jun 11.
Clinical trial NCT04212936: Optimum-pressure for Reducing Postoperative Shoulder-tip Pain in Laparoscopic Cholecystectomy
Official title: Optimum-pressure for Reducing Postoperative Shoulder-tip Pain in Laparoscopic Cholecystectomy, a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 84
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laparoscopic cholecystectomy (LC) is the standard treatment of gallbladder disease. LC is the common procedure for general surgeons. Although LC is a safe procedure with very low mortality (\<1%), it has some associated major morbidity. Bile duct injury is the most serious complication of LC. However, there are some postoperative morbidity including shoulder-tip pain. The incidence of shoulder-tip pain is about 15-45%, which might be influencing the patient outcome including length of hospital stay. From the previous studies, one of the important factor associated with this condition is pneumoperitoneum pressure. Thus, the suggestion of the intra-abdominal pressure should be low pressure as about 8 mmHg. However, the optimum pressure for the low-pressure during laparoscopic cholecystectomy is controversial.

Detailed description: We designed the prospective randomized controlled trial to comparing the postoperative shoulder tip pain between two low pressure level (8 and 10 mmHg) during laparoscopic cholecystectomy. After the enrolled participant signed the inform consent, the participant was randomly assigned to 8 or 10 mmHg group. The standard procedure of the laparoscopic cholecystectomy was performed by experience surgeons. During the operation, the pressure limit can be adjusted to facilitate the procedure according to the surgeons. Following the operation, the investigator will ask about the shoulder tip pain from the participant during 48 hours. The standard of care including pain medication during postoperative period was performed.

Eligibility criteria: Inclusion Criteria:

1. Age \> 15 years
2. Elective procedure of laparoscopic cholecystectomy
3. Sign to Inform consent

Exclusion Criteria:

1. Emergency surgery
2. Concomitant other procedure performed
3. Deny to participant

Primary outcomes:
measure: Shoulder tip pain
timeFrame: 48 hours
Secondary outcomes:
measure: Change of intra-abdominal pressure
timeFrame: Immediately after surgery
measure: Difficulty of the operation
timeFrame: Immediately after surgery
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Study officials:
affiliation: Faculty of Medicine Ramathibodi Hospital, Mahidol University
name: Narongsak Rungsakulkij, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01573936: Quality of Life in Adult Neurological Patients
Official title: The Influence of Rehabilitation on Quality of Life in Adult Patients With Neurological Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Acquired Brain Injury
Poliomyelitis
Keywords: acquired brain injury
health-related quality of life
poliomyelitis survivor
rehabilitation
spinal cord injury
completed the WHOQOL-BREF
Lead sponsor: Associação de Assistência a Criança Deficiente
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purposes of this study were to evaluate the influence of an interdisciplinary rehabilitation program in the improvement of the health-related quality of life among adult neurological patients and to identify the sociodemographic and clinical associated characteristics. Subjects with spinal cord injury, acquired brain injury and poliomyelitis survivors participated in the study. All participants underwent a rehabilitation program (RP) from January 2008 through July 2010, which consists of 40-minutes of many therapies for 1-2 days a week. The WHOQOL-BREF was applied at the initial and discharge assessments.


Eligibility criteria: Inclusion Criteria:

* diagnosed with spinal cord injury, acquired brain injury and poliomyelitis survivors
* at least 18 years old
* consented to participate in the study

Exclusion Criteria:

* cognitive problems to understand and to respond the assessment instrument, according to medical files description and interviewer previous judgment

Primary outcomes:
measure: WHOQOL-BREF
timeFrame: participants will be followed for the duration of rehabilitation program, an expected average of 7 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06625736: Anti-obesity Effects of Dandelion (Taraxacum Officinale L.)
Official title: Anti-obesity Effects of Dandelion (Taraxacum Officinale L.) in Premenopausal Obese Women: Impacts on Appetite, Energy Intake and Lipid Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese Women
Perimenopause
Keywords: Dandelion
Premenopausal Obese Women
Anti-obesity
Lead sponsor: October 6 University
Sponsor class: OTHER
Collaborators: name: Pharos University in Alexandria
First posted: 2024-10-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study investigates the effectiveness of the natural product Dandelion in treating obesity in premenopausal women through a randomized interventional trial, measuring various parameters and biomarkers.

Detailed description: The study aims to explore the anti-obesity effects of dandelion supplementation in premenopausal obese women. The research will measure changes in appetite, energy intake, body weight, composition, lipid profile, and inflammatory markers, providing evidence of dandelion\&#39;s efficacy as an anti-obesity phototherapy. The randomized interventional trial will measure multiple parameters and biomarkers.

Eligibility criteria: Inclusion Criteria:

Premenopausal women with obesity. Age between 18-45 years Stable body weight in the past 3 months

Exclusion Criteria:

Pregnancy Breastfeeding Diabetes Cardiovascular diseases kidney or liver diseases use of medications that affect body weight Smoking Allergy to dandelion or related plants

Primary outcomes:
measure: Changes in body weight
timeFrame: monthly change, assessed up to 3 months
measure: Change in fat mass
timeFrame: Monthly change, assessed up to 3 months
Secondary outcomes:
measure: Appetite Ratings
timeFrame: monthly change, assessed up to 3 months
measure: Dietary intake via 24-hour recalls
timeFrame: Recorded for patients daily, assessed up to 3 months
measure: Lipid profile
timeFrame: Monthly change, assessed up to 3 months
measure: CRP
timeFrame: Monthly change, assessed up to 3 months
measure: TNF-α
timeFrame: Monthly change, assessed up to 3 months
measure: IL-6
timeFrame: Monthly change, assessed up to 3 months
measure: IL-16
timeFrame: Monthly change, assessed up to 3 months
measure: Glycemic indices
timeFrame: Monthly change, assessed up to 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 University Hospital
Study officials:
References:
Clinical trial NCT06914336: Hepatic Doppler to Assess Venous Congestion During Invasive Mechanical Ventilation (DOHECOV)
Official title: Hepatic Doppler to Assess Venous Congestion During Invasive Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congestion, Venous
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2025-04-06
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 were included if they were intubated for more than 24 hours. Patients were excluded if they had chronic end-stage renal disease on admission, atrial fibrillation, cirrhosis, portal thrombosisrefusal to participate, whose non-opposition could not be obtained from themselves or their trusted support person in the event of incapacity or if they were under legal protection.

S/D velocity ratio was measured as well as veinous congesion parameters such as weight variation, cumulative fluid balance, peripheral edema, central venous pressure, urine output and acute kidney failure KDIGO stage.

Brief summary: The purpose of the study is to investigate venous congestion using hepatic vein doppler for ICU patients with invasive mechanical ventilastion. The primary outcome is the systolic to diastolic hepatic vein velocity ratio S/D . The objective is to find a significant association between S/D and different congestion indicators.


Eligibility criteria: Inclusion Criteria:

* intubated for more than 24 hours

Exclusion Criteria:

* Chronic end-stage renal disease on admission
* Atrial Fibrillation
* Cirrhosis
* Portal thrombosis
* Refusal to participate
* non-opposition could not be obtained from themselves or their trusted support person in the event of incapacity
* Under legal protection.

Primary outcomes:
measure: Systolic to diastolic hepatic vein velocity ratio S/D
timeFrame: 24 hours after intubation and after every 48 hours until extubation up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT01826136: Effect of Vibratory Expiratory Pressure on Pulmonary Function After Lung Resection Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Resection Surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative airway clearance and recovery of pulmonary function after lung resection is critical in patients undergoing pulmonary resection surgery. The investigators hypothesized that vibratory positive expiratory pressure using the Acapella device may improve pulmonary function recovery in patients undergoing video-assisted thoracoscopic lung resection surgery.


Eligibility criteria: Inclusion Criteria:

* patients between 20 and 65 years old
* undergoing video-assisted thoracoscopic lung resection surgery for suspicious lung cancer
* admission to intensive care unit in extubate state
* with intravenous patient-controlled analgesia

Exclusion Criteria:

* body mass index of less than 15 kg/m2 or more than 30 kg/m2
* history of respiratory tract infection within 3 months
* emergency surgery
* preoperative supplemental oxygen or ventilator care
* preoperative PaO2 of less than 70 mmHg or PaCO2 of more than 50 mmHg
* preoperative FEV1 of less than 30% of predicted value
* unconsciousness or neuromuscular disease

Primary outcomes:
measure: FEV1 on the third postoperative day
timeFrame: 3 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT02403336: Health Education in Perimenopausal Women to Promote Self-care and Quality of Life
Official title: Health Education in Perimenopausal Women to Promote Self-care and Quality of Life: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perimenopausal Women
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
Collaborators: name: Instituto de Salud Carlos III
name: Fondo de Investigacion Sanitaria
First posted: 2015-03-31
Enrollment: 356
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective: To evaluate the efficiency of a group intervention opposite to the usual care to improve the quality of life, measured with the SF-12 questionnaire, in women between 45-55 years to the primary health care centres.

Detailed description: Methods: clinical controlled trial with parallel groups, random assignment of primary care units and blinded evaluation of principal label.

Setting: study in primary health care centres (PHCCs) of Madrid Health Service and Castilla León Health Service.

Subjects: Women between 45-55 years to medical consultation in primary care. Intervention: application of good clinical practice procedure and cognitive - behavioural grupal intervention.

Sample size: N=355 patients. Data: Principal response variables: quality of life measured with the SF-12 questionnaire. Secondary response Variables: visits number, medicine /month number, and transitory disability days. Other prognosis and descriptive variables.

Data analysis: Main effectiveness will be analyzed by comparing the improvement in 4 or more points in the SF-12 Mental Health area at 6, 12, 18 y 24 months post- intervention, between intervention and control group. Logistic regression will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect, recorder will be taken in account in this analysis. All statistical tests will be performed with intention to treat.

Eligibility criteria: Inclusion Criteria:

* 45-55 years women
* users of the Health Center
* able to follow the demands of the study: does not have the intention to move from home in the next 24 months
* have ability to read and write the Spanish language and agreeing to participate by giving their informed consent in writing.

Exclusion Criteria:

* Women immobilized at home, with mental disorder or cognitive impairment and/or sensory impairments that prevent to participate in a group intervention.

Primary outcomes:
measure: Quality of Life
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Moralzarzal
country: Spain
facility: Lorena LOPEZ-CASTAÑON
state: Madrid
Study officials:
References:
Clinical trial NCT04121936: The Prevalence of Lower Urinary Tract Symptoms (LUTS) in Poland
Official title: The Prevalence of Lower Urinary Tract Symptoms (LUTS) in Poland: Epidemiology of LUTS (Poland LUTS) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: To Evaluate Lower Urinary Tract Symptoms (LUTS) in Poland
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
Collaborators: name: Piotr Chlosta
First posted: 2019-10-10
Enrollment: 6000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Representative group of Polish population

Brief summary: The first large population-based study to evaluate lower urinary tract symptoms (LUTS) in Poland. The study objective is to assess the prevalence and bother of LUTS in the population aged ≥40 years in Poland.

Detailed description: The first large population-based study to evaluate lower urinary tract symptoms (LUTS) in Poland. The study objective is to assess the prevalence and bother of LUTS in the population aged ≥40 years in Poland.

This study will be conducted as a telephone survey with assessment of LUTS using a standardized protocol, which included the International Prostate Symptom Score (IPSS) and, for overactive bladder (OAB), the OAB-V8 questionnaire. Participants will be asked to rate how often they experienced individual LUTS and the degree of associated bother.

The study will be performed in a representative group of Polish population (n = 6,000) covering all geographic regions of Poland (defined by the Central Statistical Office of Poland).

Eligibility criteria: Inclusion Criteria:

Age \>40

Exclusion Criteria:

Age \<40 Pregnancy Urinary tract infection in the past 4 weeks

Primary outcomes:
measure: Prevalence of LUTS
timeFrame: Through study completion, an average of 3 months
measure: Symptom bother of LUTS
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Prevalence of specific symptoms
timeFrame: Through study completion, an average of 3 months
measure: Symptom bother of specific symptoms
timeFrame: Through study completion, an average of 3 months
measure: Prevalence of OAB
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Department of Urology Jagiellonian University
Study officials:
References:
citation: Przydacz M, Dudek P, Golabek T, Chlosta P. Relationship between Lower Urinary Tract Symptoms and Treatment-Related Behavior in an Eastern European Country: Findings from the LUTS POLAND Study. Int J Environ Res Public Health. 2021 Jan 18;18(2):785. doi: 10.3390/ijerph18020785.
citation: Przydacz M, Golabek T, Dudek P, Lipinski M, Chlosta P. Prevalence and bother of lower urinary tract symptoms and overactive bladder in Poland, an Eastern European Study. Sci Rep. 2020 Nov 13;10(1):19819. doi: 10.1038/s41598-020-76846-0.
Clinical trial NCT02884336: Lactobacillus Plantarum: Thumb Osteoarthritis Following Orange Peeling
Official title: Lactobacillus Plantarum: Thumb Osteoarthritis Following Orange Peeling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lactobacillus Plantarum
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 1
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A patient who had osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel.

Brief summary: Case Description osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being the orange zest and the bacteria is considered harmless.

Detailed description: Case Description osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being the orange zest and the bacteria is considered harmless.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of an osteoarthritis,
* Amputation of the distal phalanx of the right thumb

Exclusion Criteria:

* Not exclusion criteria

Primary outcomes:
measure: Identification of Lactobacillus plantarum
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Mizrahi Assaf, Assaf
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06640036: FILIP: Fat Intake, Inflammation and LIPids
Official title: FILIP: Fat Intake, Inflammation and LIPids
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiometabolic Risk Factors
Inflammation
Microbiota
Keywords: Blood lipid profile
Low grade inflammation
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Chalmers University of Technology
First posted: 2024-10-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Low-grade inflammation is involved in the pathogenesis of type 2 diabetes and cardiovascular disease. Increasing evidence suggests that dietary intake may be involved in the inflammatory process. How nutritional composition of the diet affects the inflammatory response is however not well understood.

The aim of this project is to study if intake of three different fat sources induce different effects on inflammation markers, blood lipids, blood glucose and the microbiota.


Eligibility criteria: Inclusion Criteria:

* Age 18-60
* Willing to eat the study diet

Exclusion Criteria:

* malabsorption-related condition
* contraindications to consume a high fat diet
* intolerance to any foods used in the study (e.g. cow's milk, egg, gluten)
* established cardiovascular disease, diabetes or cancer
* current use of medication known to affect lipid metabolism (e.g. statins) or inflammation (e.g. NSAID, glucocorticoids).
* hemoglobin \&lt;100 g/L
* ongoing pregnancy or lactation

Primary outcomes:
measure: Total cholesterol
timeFrame: Baseline and 1 week
measure: hs-CRP
timeFrame: Baseline and 1 week
Secondary outcomes:
measure: Inflammation markers
timeFrame: Baseline and 1 week
measure: Blood lipid propfile
timeFrame: Baseline and 1 week
measure: Glucose
timeFrame: Continuous during 1 week
measure: Microbiota
timeFrame: Baseline and 1 week
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: University of Gothenburg
city: Gothenburg
country: Sweden
facility: University of Gothenburg
Study officials:
References: