louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01530048: Bioequivalence of Two Insulin Aspart Formulations (100 U/mL Versus 200 U/mL)
Official title: A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial, Assessing the Bioequivalence Between Insulin Aspart 100 U/mL and Insulin Aspart 200 U/mL in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to test if there is bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin aspart 200 U/mL (U200) formulation.


Eligibility criteria: Inclusion Criteria:

* Considered to be healthy as judged from vital signs, medical history, ECG (electrocardiogram), laboratory values, and physical examination
* Body mass index between 18 and 27 kg/m\^2 (both inclusive)
* Non-smoker
* Fasting blood glucose maximum 6 mmol/L
* HbA1c below 6.4%

Exclusion Criteria:

* Pregnant or breast-feeding women
* Women not using acceptable methods of contraception without difficulties for at least three months prior to trial start (screening), including intrauterine devices, oral contraceptives, hormonal implants, or sterilisation
* Clinically significant abnormal laboratory values (as judged by the Investigator)
* Close relative with type 1 diabetes mellitus (father, mother, sister or brother)
* Intake of alcohol within the last 24 hours prior to screening and drug administration visits
* Blood donation or blood loss of more than 500 mL within the 3 last months before screening
* Strenuous exercise within 48 hours before screening as well as drug administration and followup
* Smoking during the past month before drug administration

Primary outcomes:
measure: Area under the curve (AUC) in the interval of 0-6 hours
measure: Cmax, maximum concentration
Secondary outcomes:
measure: AUC in the interval of 0-infinity hours
measure: tmax, time to reach Cmax
measure: Terminal rate constant
measure: Vz/f, volume of distribution during terminal phase
measure: t½, terminal half-life
measure: AUCGIR, area under the glucose infusion rate value curve
measure: GIRmax, maximum glucose infusion rate value
measure: tGIRmax, time to maximum glucose infusion rate value
measure: Adverse events
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00035048: Treatment of Patients With Major Depressive Disorder With MK0869 (0869-068)(COMPLETED)
Official title: A Double-Blind, Placebo-Controlled, Multicenter Study of the Long-Term Efficacy of MK0869 in the Maintenance of Antidepressant Effect in Geriatric Outpatients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-05-03
Enrollment: 540
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.

Detailed description: The duration of treatment is 10 weeks.

Eligibility criteria: Patients with Major Depressive Disorder

Primary outcomes:
measure: HAMD-17 score </= 10 after 10 weeks; maintenance of antidepressant effect for 6-10 months; tolerability
timeFrame: After 10 weeks & 6-10 months
Secondary outcomes:
measure: CGI-S score change from Week 10 at Month 6; HAMD-17 total score change from Week 10 at Month 6; MADRS total score change at Month 6, HAMA total score change at Month 6
timeFrame: 6 Months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02854930: Near Death Experience (NDE) and Migraine
Official title: Near Death Experience (NDE) and Migraine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Migraine
Near Death Experience
Keywords: Clinical death
state of consciousness
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subject who experienced a near death experience (NDE).

Brief summary: Migraine is a common disabling primary headache disorder. Epidemiological studies have documented its high prevalence and high socio-economic and personal impacts. Migraine affects more than 20% of the French population. However, the physiopathology of migraine is always partially known. Cortical spreading depression (CSD) is the widely accepted as the electrophysiologic substrate of migraine aura. CSD is a slowly propagating wave of transient neuronal and glial depolarization. The near death experience (NDE) is a rare, but well known phenomenon. NDE are profound psychic experiences commonly occuring in life-threatening conditions. Among the neurological hypotheses, epilepsy, temporal lobe disorders , REM-sleep intrusion have been discussed. However, the role of DCE has never been discussed. The goals of this study are : to see if there is an epidemiological link between NDE and migraine/ to specify if NDE was followed by a migrainous headache.


Eligibility criteria: Inclusion Criteria:

* Subject who experienced an NDE defined by the occurrence, when the subject is in a state of clinical death or a particular state of consciousness of a following event: body output experience, disembodiment, for a tunnel and / or light;
* Topic recorded in the EMI database (Dr. Postel, National Center for Education, Research and Information on the conscience;
* Topic agreeing to participate in the study.

Exclusion Criteria:

* Patient mental condition or disorder or psychiatric history or any other factor limiting the ability to participate in an informed manner and compliant to the study;
* Other than obtained Participation Agreement.

Primary outcomes:
measure: Quality of life
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille Hôpital de la Timone
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle Desalbres
role: STUDY_DIRECTOR
References:
Clinical trial NCT00741130: Corrected Measurement of the Retinal Nerve Fiber Layer Thickness by Optic Disc Configuration With the Cirrus HD OCT
Official title: Corrected Measurement of the Retinal Nerve Fiber Layer Thickness by Optic Disc Configuration With the Cirrus HD OCT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Myopia
Keywords: retinal nerve fiber layer
optic nerve head
Cirrus OCT
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2008-08-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers of our opthalmologic clinic

Brief summary: Because the measurement of the retinal nerve fiber layer thickness is very sensitive to the position of measurement, it may be incorrect in patients with the tilted disc. In the present study, the corrected RNFL thickness by the optic nerve head configuration using the Cirrus HD OCT will be evaluated. If the corrected RNFL thickness is more sensitive to detect the localized RNFL defect, the present software should be upgrade to reflect the optic nerve head configuration.

Detailed description: Finding the localized retinal nerve fiber layer (RNFL) defect and measuring the RNFL thickness are two main issues for early glaucoma detection. A recently developed imaging device, the Cirrus HD OCT, offers more detailed informations about retina architecture including optic nerve head. To calculate the RNFL thickness, the software of the Cirrus HD OCT supposes an ideal optic nerve head. However, in the cases with not ideal optic disc configuration, the measurement of the RNFL thickness is not correct. Because the measurement of the RNFL thickness is extremely sensitive to the position of measurement, patients with the tilted disc are in danger of misdiagnosis. In the present study, we want to correct the RNFL thickness measurement according to the optic nerve head configuration using the Cirrus HD OCT. If the corrected RNFL thickness is more sensitive to detect the localized RNFL defect, the present software should be upgrade to reflect the optic nerve head configuration.

Eligibility criteria: Inclusion Criteria:

* normal controls or glaucoma patients
* signal intensity of the OCT image \> 8
* cooperative subjects

Exclusion Criteria:

* spherical equivalent refractive errors \> +4 diopters or \< -4 diopters
* significant media opacity
* previous intraocular surgery

Primary outcomes:
measure: the Cirrus HD OCT
timeFrame: when the OCT images are taking
Secondary outcomes:
measure: automated visual field
timeFrame: when the OCT images are taking
measure: red-free fundus photo
timeFrame: when the OCT images are taking
measure: refractive errors
timeFrame: when the OCT images are taking
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gong Je Seong
Study officials:
affiliation: Yonsei University
name: Gong Je Seong, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00444730: Urology Database for Outcomes Research
Official title: Urology Database for Outcomes Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Pelvic Pain
Incontinence
Keywords: Prostate Cancer
Prostatectomy
Pelvic pain
urgency
incontinence
frequency
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: William Beaumont Hospitals
First posted: 2007-03-08
Enrollment: 860
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing radical prostatectomy or InterStim implantation at William Beaumont Hospital.

Brief summary: The purpose of initiating the urology database is to collect relevant retrospective data via chart review related to patients undergoing radical prostatectomy via the retropubic, perineal, laparoscopic, and robotic assisted laparoscopic approaches and InterStim implantation. This data will be utilized to evaluate the health benefits and outcomes of each of these procedures to enhance care and treatment.

Detailed description: The objective of this study is to initiate and maintain a patient information database that will be used to study the impact of each surgical procedure on patients' overall health, quality of life, and bowel/bladder/sexual function.

The study coordinator will, on an ongoing basis, abstract needed medical information from inpatient hospital and physician office records for inclusion into the database.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing radical prostatectomy or InterStim implantation at William Beaumont Hospital.

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Kenneth Peters, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00516230: Establishing Effective Screening Methods for Diagnosing Hereditary Nonpolypoisis Colorectal Cancer
Official title: Establishing Effective Screening Methods for Diagnosing Hereditary Nonpolypoisis Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colonic Neoplasms
Keywords: Colonic Neoplasms
Lynch syndrome
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2007-08-15
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Correct identification of Lynch syndrome at the time of colorectal cancer presentation is important. We aim to find best ways to screen patients with colorectal cancer in Korea.

Detailed description: Patients with newly diagnoised colorectal cancer will be eligible. They will undergo detailed history taking including family history, and molecular stuidies including microsatellite instability test and immunohistochemistry for DNA mismatch repair protein with pre-selection. Any abnormal finding in molecular stuides will be offered genetic testing (after testing methylation status for patients with abnormalities in MLH1).

Eligibility criteria: Inclusion Criteria:

* Colorectal cancer

Exclusion Criteria:

* Histology showing other than adenocarcinoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
Study officials:
affiliation: Division of Gastroenterology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Dong Kyung Chang, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06643130: Evaluate the Efficacy and Safety of Co-administration of JW0104+C2402 in Patients with Hypertension and Dyslipidemia
Official title: A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0104+C2402 in Patients with Hypertension and Dyslipidemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Hypertension
Dyslipidemia
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2024-10-16
Enrollment: 162
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0104+C2402 in Patients with Hypertension and Dyslipidemia

Detailed description: To evaluate the efficacy and safety of co-administration of JW0104+C2402 in comparison with co-administration of JW0104+C2403 or C2402 alone in patients with hypertension and dyslipidemia.

Eligibility criteria: Inclusion Criteria:

* Patients with hypertension and dyslipidemia

Exclusion Criteria:

* The subject not meet the specified msBP and LDL-C level

Primary outcomes:
measure: Change from baseline in msSBP (Systolic Blood Pressure)
timeFrame: week 8
measure: Percent change from baseline in LDL-C (Low-Density Lipoprotein Cholesterol)
timeFrame: week 8
Secondary outcomes:
measure: change from baseline in msSBP
timeFrame: week 4
measure: Change and percent change from baseline in LDL-C
timeFrame: week 4
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangdong Sacred Heart Hospital
Study officials:
affiliation: JW Pharmaceutical
name: Minjung Kim
role: STUDY_CHAIR
References:
Clinical trial NCT03469830: The Development and Application of "Scar-care" Padding on Management of Hypertrophic Scar
Official title: The Effectiveness of a Smart Scar Care Pad and Pressure Therapy Versus Pressure Therapy in Hypertrophic Scar Management: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cicatrix, Hypertrophic
Rehabilitation
Keywords: insert
pressure therapy
silicone gel
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study explores the smart scar care pad's potential therapeutic effect in treatment hypertrophic scar while elucidating the adverse effects if there is any. Half of the participant receives traditional treatment of pressure garment and the other half receives the smart scar care pad together with pressure garment.


Eligibility criteria: Inclusion Criteria:

1. Subjects with Hypertrophic Scar(HS);
2. the HS had a total Vancouver Scar Scale (VSS) score of 4 or higher and the score of each item equal to or greater than 1;
3. subjects age between 20 and 70 years, cooperative, and good compliance with treatment.

Exclusion Criteria:

1. the HS area had an open wound or infection;
2. the HS had been treated with steroid injections or other intervention (such as traditional Chinese medicine or laser therapy) before the study; or
3. the patient had a medical condition that might affect wound healing (e.g., diabetes mellitus or another serious medical problem).

Primary outcomes:
measure: Change of Scar Pliability measured by the DermaLab Combo
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Change of Scar Thickness measured by the diagnostic ultrasound system
timeFrame: baseline and 6 weeks
measure: Change of Scar Pigmentation measured by the DermaLab Combo
timeFrame: baseline and 6 weeks
measure: Change of Scar Vascularity measured by the DermaLab Combo
timeFrame: baseline and 6 weeks
measure: Occurrence of blistering
timeFrame: up to 6 weeks
measure: Occurrence of skin breakdown
timeFrame: up to 6 weeks
measure: Occurrence of rash
timeFrame: up to 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00804830: Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer
Official title: Phase 2 Study With Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Thyroid Neoplasms
Carcinoma
Thyroid Cancer
Metastatic Cancer
Keywords: adjuvant
Anaplastic thyroid cancer
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Anaplastic Thyroid Cancer is a very aggressive disease. The investigators believe that angiogenesis is very important for these tumors to progress. Preclinical data is suggesting this. This is why we we prospectively want to treat these patients with avastin (and doxorubicin). However, local control is of major concern. Therefore, patients are initially treated with hyperfractionated radiotherapy and undergo surgery. Then they can enter this study.

Detailed description: Patients with Anaplastic Thyroid Cancer have a poor prognosis. We will treat the patients initially with our standard radiochemotherapy, which consists of doxorubicin 20mg fixed dose/week and hyperfractionated radiotherapy 1,6 Gy twice daily up to 46 Gy in total. The first week during radiotherapy, they will also receive Avastin 15mg/kg. 1-2 weeks after radiotherapy patients will undergo surgery of their primary tumor. After this "standard" therapy patients can be included in this study. Treatment is 20 mg fixed dose doxorubicin q1w and avastin 15mg/kg q3w. Treatment will continue maximum 6 months or until progress or until intolerable side effects occur.

Eligibility criteria: Inclusion Criteria:

* cytologically or histologically verified anaplastic thyroid cancer
* completed standard therapy
* operated with R0 or R1 surgery
* Performance Status 0-2 (if pulmonary mets PS 0-1)
* normal wound healing
* neutrophils \> 1,5 million/ml
* platelets \> 100 million/ml
* bilirubin \< 2 ULN
* creatinin \< 150mikromol/L

Exclusion Criteria:

* PS 3-4 (if pulmonary mets 2-4)
* R2 resection of primary tumor

Primary outcomes:
measure: Overall Survival
timeFrame: 2-5 years
Secondary outcomes:
measure: Response rate
timeFrame: 2-5 years
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Jubileumskliniken, Sahlgrenska universitetsjukhuset
city: Lund
country: Sweden
facility: Dep of Oncology, Lund University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Dep of Oncology, Lund University Hospital
name: Jan Tennvall, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00174330: Comparing Amlodipine/Atorvastatin Co-Administration To Amlodipine Alone In Patients With Hypertension And Dyslipidemia
Official title: A Multi-Center, Randomized, Open-Label Study To Evaluate Efficacy And Safety Of Dual Therapy With Atorvastatin Plus Amlodipine When Compared Amlodipine Therapy Alone In The Treatment Of Subjects With Concurrent Hyperlipidemia And Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Hyperlipidemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 330
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: To evaluate efficacy of the dual therapy of atorvastatin + amlodipine vs. amlodipine alone .


Eligibility criteria: Inclusion Criteria:

* Subjects with a diagnosis of both hyperlipidemia and hypertension.

Exclusion Criteria:

* Subjects with Type 1 diabetes mellitus or Type 2 diabetes mellitus.
* Subjects with other atherosclerotic disease.

Primary outcomes:
measure: To evaluate efficacy of the dual therapy of atorvastatin 10mg or 20mg + amlodipine 5mg or 10mg vs. amlodipine 5mg or 10mg alone
Secondary outcomes:
measure: To provide comparative evaluation of the safety profile of the dual therapy with atorvastatin + amlodipine versus amlodipine alone.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Pfizer Investigational Site
state: Beijing
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Nanjing
country: China
facility: Pfizer Investigational Site
state: Jiangsu
city: Shen Yang
country: China
facility: Pfizer Investigational Site
state: Liaoning
city: Shanghai
country: China
facility: Pfizer Investigational Site
state: Shanghai
city: Hangzhou
country: China
facility: Pfizer Investigational Site
state: Zhejiang
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Tianjin
country: China
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: