louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02491528: A Phase III Study of Insulin Aspart Injection to Evaluate the Efficacy and Safety
Official title: A Multi-center, Randomized, Open-label, Parallel-group, Phase Ⅲ Study to Evaluate the Efficacy and Safety of Insulin Aspart Injection in Patients With Diabetes Mellitus Compared to NovoRapid®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Lead sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2015-07-08
Enrollment: 563
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 is a multicenter, randomized, open, parallel group, active-controlled study. The study period is 25 to 26 weeks, including screening period of 1-2 weeks and treatment period of 24 weeks.

Detailed description: After the screening visit, all patients who met all inclusion criteria and do not meet any of the exclusion criteria were randomized into the experimental group or the controlled group. The subjects in the experimental arm will receive insulin aspart injection combined with basal insulin (Lantus ®), and the subjects in the controlled arm will receive NovoRapid ® (active control) combined with basal insulin (Lantus ®). The experimental drug or the controlled drug will be administered subcutaneously prior to three meals (or can be administered immediately after meal if necessary), and the basal insulin (Lantus ®) will be administered at bedtime. The treatment period is 24 weeks, during which the subjects will be followed up at the clincic cetres at 1, 2, 4, 8, 12, 18, 24 weeks of treatment. At the end of 24-week treatment, if the adverse events continue, the subjects will be followed until recovery or stabilization of the AEs.

Eligibility criteria: Inclusion Criteria:

* Patients were diagnosed with diabetes；
* BMI≤35.0 kg/m2；
* Insulin therapy for at least 3 months before recruitment；
* HbA1c7\~13%

Exclusion Criteria:

* Patients to study drug allergy；
* to Liver and kidney impairment；
* Liver and kidney impairment；
* used systemic steroid treatment in past 2 months .

Primary outcomes:
measure: The change of relative baseline HbA1c
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Weifang
country: China
facility: Affiliated hospital of Weifang Medical University
state: Shandong
city: Shanghai
country: China
facility: The 6th people's hospital of Shanghai
state: Shanghai
Study officials:
affiliation: The 6th people's hospital of Shanghai
name: WP Jia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05836428: Biomarker Analysis in Post-COVID Patients
Official title: Biomarker Analysis in COVID and Post-COVID Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-COVID-19 Syndrome
Keywords: persistent headache
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population

Brief summary: Headache is one of the most common neurological manifestations of COVID-19. However, it is unclear whether chronic headache after the initial diagnosis, is associated with ongoing damage of the central nervous system. We investigate cpost-COVID-19 patients with persistent headache lasting longer than 3 weeks, to hospitalized acute COVID-19 patients with neurological symptoms and to other non-COVID-19 disease-controls. Readout are neurologial and glial biomarkers in CSF.

Detailed description: Measurements of neuronal and glial markers in CSF were performed on a SIMOA analyzer (Quanterix) using the Neurology 4-Plex A (Nf-L, Tau, GFAP, UCH-L1) kit.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of COVID, Parkinson's disease, primary headache, Multiples Sclerosis, facial paralysis
* Persistent post-COVID-19 headache after 3 months of infection
* Post COVID-patients without persistent headache
* must be able to perform lumbar puncture

Exclusion criteria

* unknown history of COVID infection
* lumbar puncture not possible

Primary outcomes:
measure: Biomarker analysis in CSF
timeFrame: after 3 months of initial infection
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Laura de Boni
Study officials:
affiliation: DLR German Aerospace Center
name: Laura de Boni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03404128: Long Term Follow-up of Hippocampal DBS for Refractory Epilepsy
Official title: Long Term Follow-up of Patients Treated With Hippocampal Deep Brain Stimulation for Refractory Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractory Epilepsy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2018-01-19
Enrollment: 6
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: Patients with refractory epilepsy treated with hippocampal DBS

Brief summary: Follow up of the patients at Ghent University Hospital treated with hippocampal DBS for refractory epilepsy.

Endpoints:

* Long term evaluation of the effects of hippocampal DBS on seizure frequency and cognition
* Evaluation of the satisfaction of patients and neurologist regarding the rechargeable DBS battery


Eligibility criteria: Inclusion Criteria:

* Treated with hippocampal DBS for refractory epilepsy at Ghent University Hospital

Exclusion Criteria:

* (none)

Primary outcomes:
measure: Seizure frequency per month based on seizure diary
timeFrame: Every six months (up to 2 years after implantation of rechargeable device)
Secondary outcomes:
measure: Cognition
timeFrame: Yearly (up to 2 years after implantation of rechargeable device)
measure: Number of device problems
timeFrame: Every six months (up to 2 years after implantation of rechargeable device)
measure: Number of adverse events
timeFrame: Every six months (up to 2 years after implantation of rechargeable device)
Other outcomes:
Locations:
Study officials:
affiliation: UZ Gent
name: Paul Boon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002328: Azithromycin in the Treatment of Cryptosporidiosis in Patients Who Have Not Had Success With Other Drugs
Official title: Oral/Intravenous Azithromycin in the Treatment of Cryptosporidiosis in Patients Whose Disease Has Not Been Controlled by Conventional Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryptosporidiosis
HIV Infections
Keywords: Antidiarrheals
Cryptosporidiosis
Diarrhea
Acquired Immunodeficiency Syndrome
Azithromycin
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To provide azithromycin for the treatment of individual patients with proven cryptosporidiosis whose disease has persisted or progressed despite prior therapies.


Eligibility criteria: Inclusion Criteria

Patients must have:

* Cryptosporidiosis infection.
* Life expectancy of at least 1 week.
* Failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic or other therapies for cryptosporidiosis.
* Consent of parent or guardian for patients under the legal age of consent. Patients with documented favorable response to azithromycin under Pfizer protocol 066-143 may receive maintenance therapy under this protocol.

Patients with persistent diarrhea requiring intravenous (IV) fluid therapy to maintain hydration may receive IV azithromycin after approval by the clinical monitor. Patients whose disease worsens despite a minimum of 2 weeks of oral therapy or patients whose disease shows no improvement after 4 weeks of oral therapy will also be considered for a trial period of intravenous azithromycin.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Known hypersensitivity or significant intolerance to macrolide antibiotics.
* Eligibility and current treatment at a medical center performing study 066-143, another study of azithromycin for treatment of cryptosporidiosis in AIDS patients.

Required:

* Must have failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic therapies for cryptosporidiosis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Groton
country: United States
facility: Pfizer Central Research
state: Connecticut
Study officials:
References:
Clinical trial NCT04405128: Brain TV (Tissue Velocimetry) for Emergency Assessment of Suspected Stroke
Official title: Brain TV (Tissue Velocimetry) for Emergency Assessment of Suspected Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: Nihon Kohden
First posted: 2020-05-28
Enrollment: 102
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: Participants with suspected stroke will be identified and recruited by the Emergency Department (ED) research team and/or members of the direct care team within the Hyper Acute Stroke Unit (HASU).

Brief summary: This study uses a Doppler ultrasound technique being developed at the University of Leicester called \&#34;Brain Tissue Velocimetry\&#34; (Brain TV), to investigate brain tissue motion over the cardiac cycle.

Detailed description: Brain motion is highly sensitive to heart and brain biomechanics, but the impact of brain injury on brain tissue motion has yet to be explored. Preliminary brain tissue motion measurements from a small number of patients suggest that brain biomechanics may be disturbed in the presence of brain injury. This study combines transcranial tissue Doppler (TCTD) ultrasound with brain magnetic resonance imaging (MRI) to establish whether analysis of brain tissue motion provides clinically useful information for emergency diagnosis and monitoring of suspected stroke.

Eligibility criteria: Inclusion Criteria:

* Participant (or consultee) is willing and able to give informed consent (or assent) for participation in the study.
* Adult, aged 18 years or over.
* Suspected stroke (any severity and any stroke type).

Exclusion Criteria:

* Unable (in the investigators' opinion), or unwilling, to comply with the study requirements.
* Patients with pre-existing chronic brain conditions that may make affect informed consent, such as severe learning difficulties, dementia, or Alzheimer's disease, will be excluded.

Primary outcomes:
measure: MRI measurement
timeFrame: Up to 5 days.
measure: TCTD measurement
timeFrame: Up to 5 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University of Leicester
Study officials:
affiliation: King&#39;s College, London
name: Emma M Chung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01598428: Anterior Capsule Polishing Effect on Effective Lens Position
Official title: Effect of Anterior Capsule Polishing on Effective Lens Position After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: age related cataract
phacoemulsification
anterior capsule polishing
optical coherence tomography
anterior chamber depth
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: * The purpose of this study is to evaluate effects of anterior capsule polishing on effective lens position (ELP) and actual axial movement of the intraocular lens (IOL) by measuring anterior chamber depth (ACD)
* patients with bilateral age-related cataract undergo bilateral uneventful cataract surgeries with in-the- bag implantation of a single-piece hydrophobic acrylic foldable IOL (SN60WF). The anterior capsule was extensively polished using Whitman Shepherd Double-Ended Capsule Polisher in one eye randomly, and the other not. The ACD was measured 1day, 1 week, 1month, 3 months and 6 months with anterior segment Optical Coherence Tomograph (AS-OCT) postoperatively. The actual axial movement of IOL was defined as the root mean square (RMS) of the change in ELP at each visit.


Eligibility criteria: Inclusion Criteria:

* bilateral age-related cataract
* good overall physical constitution
* uneventful surgeries of both eyes with in-the-bag IOL implantation

Exclusion Criteria:

* history of intraocular surgery or laser therapy
* history of ocular trauma or ocular disease
* high myopia
* diabetes
* severe retinal pathology
* patients who could not return on time

Primary outcomes:
measure: Effective Lens Position
timeFrame: 1 day，1 week, 1 month，3 months and 6 months postoperatively
Secondary outcomes:
measure: Uncorrected Visual Acuity(UCVA)
timeFrame: 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively
measure: Refractive Error
timeFrame: 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Ophtalmology,Qianfoshan Hospital,Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT00603928: Placebo Interventions in General Practice
Official title: Placebo Interventions in General Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Practitioners
Keywords: attitude
attitude of health personnel
ethics
bioethics
biomedical ethics
patient care
physicians
placebo effect
placebos
questionnaires
therapy
general practice
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Academy of Medical Sciences (SAMS)
First posted: 2008-01-29
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: general practitioners and pediatricians in medical practice of the canton Zurich in Switzerland

Brief summary: Physicians often have an ambivalent relationship to placebo interventions. On the one hand they know of the intriguing effect of sugar pills or saline infusions but on the other hand they mostly feel constrained to adopt scientifically proven, specific therapies for ethical reasons. Against the background of international literature one can assume that also Swiss general practitioners use several forms of placebo interventions in a significant part of their patients.

The aim of the project is to ascertain to which extent and in which way Swiss general practitioners make use of placebo interventions. Furthermore knowledge of the mode of action of placebo interventions and the perceived moral and lawful permissibility of placebo interventions and the presumed attitudes of the patients will be investigated.

The empicical core of the study is a questionnaire survey of general practitioners in urban and rural areas of Switzerland. The results and conclusions of the survey will be discussed during a workshop with interested GPs, researchers and ethicists.

The obtained data will lead to a better understanding of the application of placebo interventions in the general practice in Switzerland (how often and in which manner, accompanied by what information, for which diseases and for which patient groups placebos are applied). Moreover the study will help to articulate potential moral ambiguities of physicians using placebo interventions.


Eligibility criteria: Inclusion Criteria:

* general practitioners and pediatricians in medical practice of the canton Zurich in Switzerland

Exclusion Criteria:

* no patient encounters

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
References:
Clinical trial NCT03285828: Motivational Interviewing Training for Medical Students: a Pilot Pre-post Study
Official title: Optimising the Relationship Between Medical Students and Patients Through a Motivational Interviewing Training Programme: a Pilot Pre-post Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Change; Personality, Due to General Medical Condition
Keywords: medical education, motivational interviewing, medical empathy
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
Collaborators: name: INSERM SC10-US19
name: University of Paris 5 - Rene Descartes
First posted: 2017-09-18
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot pre-post study investigating the effects of a training programme, by comparing performance before and after its implementation
Primary purpose: OTHER

Brief summary: Objective is to evaluate the impact of a basic training programme in motivational interviewing (MI) for medical students, by comparing the ability of students to promote behavioural changes through relationship skills and to conduct a motivational interview before and after training.

Detailed description: Design: A pilot pre-post study in 20 students by comparing students' performance before and after MI training session.

Setting: Bicêtre Hospital, Assistance Publique Hôpitaux de Paris, France.

Interventions: Students received three four-hour sessions of a basic MI training over a one week period. The students interviewed for 15 minutes a caregiver playing the role of a patient, six weeks before and three weeks after the training.

Main outcome measures: Global scores by two independent raters who used the Motivational Interviewing Treatment Integrity (MITI) 3.1.1 code, perception of student's empathy by the caregivers (CARE questionnaire), self-efficacy of students to engage in a patient-centred relationship (SEPCQ score), and student's satisfaction with the odds of achieving the target goal.

Eligibility criteria: Inclusion Criteria:

* Students in clinical internships (fourth or fifth year of medical courses) in the Immunology-Infection-Inflammation-Endocrinology Division of Bicêtre Hospital, Assistance Publique Hôpitaux de Paris.
* signed consent

Exclusion Criteria:

* participation refused
* prior training in motivational interviewing

Primary outcomes:
measure: GLOBAL MITI scores (MITI = Motivational Interviewing Treatment Integrity version 3.1.1)
timeFrame: 15 mn
measure: perception of student's empathy by the caregivers
timeFrame: 15 mn
measure: self-efficacy of students to engage in a patient-centred relationship
timeFrame: 15 mn
measure: student's satisfaction with the odds of achieving the target goal.
timeFrame: 15 mn
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bicetre Hospital
name: ANTOINE CHERET
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rollnick S, Butler CC, Kinnersley P, Gregory J, Mash B. Motivational interviewing. BMJ. 2010 Apr 27;340:c1900. doi: 10.1136/bmj.c1900. No abstract available.
Clinical trial NCT01105728: Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study
Official title: Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastric Subepitelial Mass
Keywords: Gastric subepitelial mass
Endoscopic full thickness resection
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2010-04-16
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Gastric subepithelial masses might harbour gastrointestinal stromal tumors, which should get resected because of their malignant potential. To minimize the associated surgical trauma endoscopic endoluminal resection is favorable. Therefore in the current study endoscopic resection of gastric subepithelial masses is investigated. Since there is a certain risk of perforation due to the procedure, perforations get closed by placement of endoscopic clips (over-the-scope-clip \[OTSC\] clips).

Detailed description: During an initial pilot phase 8 patients receive endoscopic resection under laparoscopic control. Thereafter and after positive initial results sole endoluminal endoscopy is done for a total of 38 patients.

Eligibility criteria: Inclusion Criteria:

* Endosonographically suspicous gastric subepithelial mass \<=3 cm.

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) classes IV or V
* Pregnancy
* Bleeding disorders
* Contraindications for endoscopy
* Endosonographically shown large vessels in the area for resection

Primary outcomes:
measure: R0 Resection
timeFrame: 30 minutes
Secondary outcomes:
measure: Safety
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar
state: Bavaria
Study officials:
affiliation: Klinikum rechts der Isar
name: Alexander Meining, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum rechts der Isar
name: Stefan von Delius, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum rechts der Isar
name: Hubertus Feußner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum rechts der Isar
name: Dirk Wilhelm, MD
role: PRINCIPAL_INVESTIGATOR
References: