louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01121198: A Study to Assess Safety and Tolerability of ASP1941 After Single and Repeated Administration in Healthy Subjects
Official title: ASP1941 Phase I Study -Placebo-controlled, Single-dose and Repeated-dose Oral Administration Study in Healthy Adult Male Subjects-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Pharmacokinetics of ASP1941
Keywords: Food effect
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-05-12
Enrollment: 84
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 in healthy adult male subjects.

Detailed description: This study consists of two parts. In part-1, a single oral dose of ASP1941 or placebo is administered to healthy adult male subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy adult males. In part-2, ASP1941 or placebo are is administered by a multiple dose regimen.

Eligibility criteria: Inclusion Criteria:

* Body weight: 50.0 kg ≤ weight \< 85.0 kg
* Body mass index:17.6 ≤ BMI \< 26.4
* Those who provided written informed consent themselves

Exclusion Criteria:

* Medical history of Hepatic disease, heart disease, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disease, malignant tumor or drug allergy
* Those whose blood pressure, pulse rate, body temperature or 12-lead ECG are in the abnormal range
* Those whose lab-test results are in the abnormal range
* Those who received medical treatment within 14 days prior to the study
* Those who attended another clinical study or a post-marketing clinical trial within 120 days before the study
* Those who have received ASP1941 before
* Those who have donated at least 400ml of whole blood within 90 days before the study, at least 200ml 30 days before the study or blood component within 14 days before the study
* Those within a fasting plasma glucose level of \< 70mg/dL or 110 mg/dL or with an HbA1C. 5.8%

Primary outcomes:
measure: Safety assessed by adverse events, vital signs, 12-lead ECG and lab-tests
timeFrame: 72 hours after drug administration
Secondary outcomes:
measure: Plasma concentration of unchanged drug measured by blood sample
timeFrame: 72 hours after drug administration
measure: Blood glucose level measured by blood sample
timeFrame: 72 hours after drug administration
measure: Urinary glucose excretion level
timeFrame: 72 hours after drug administration
Other outcomes:
Locations:
city: Kantou
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT03172598: Study to Assess the Efficacy, Safety and Tolerability of MT- 8554 in Subjects With Painful Diabetic Peripheral Neuropathy
Official title: A Phase IIa, Multi-Centre, Randomised, Double-Blind, Cross-Over, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy Incorporating an Open Label Pilot Arm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Painful Diabetic Peripheral Neuropathy
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2017-06-01
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy


Eligibility criteria: Inclusion Criteria:

* Male subjects and female subjects aged ≥18 years
* Subjects who have a history of pain at least 6 months and ≤7 years attributed to diabetic peripheral neuropathy
* A body mass index ranging from 18 to 45 kg/m2

Exclusion Criteria:

* Subjects who have participated in a clinical study of any IMP (other than placebo) within 12 weeks (from last administration) prior to screening or who are currently participation in another clinical study
* Unstable or uncontrolled diabetes
* Clinically significant 12-lead ECG abnormalities

Primary outcomes:
measure: Safety and Tolerability as measured by vital signs and Adverse Events
timeFrame: Up to Day 22
measure: Efficacy as measured by reduction in pain using a numerical rating scale.
timeFrame: Up to Day 49
Secondary outcomes:
measure: Number of subjects with electrocardiogram (ECG) findings of potential clinical importance
timeFrame: Up to Day 49
measure: Plasma concentration of MT-8554
timeFrame: Up to Day 49
Other outcomes:
Locations:
city: City Name
country: Germany
facility: Investigational center
city: City Name
country: Hungary
facility: Investigational center
city: City Name
country: Poland
facility: Investigational center
Study officials:
affiliation: Mitsubishi Tanabe Pharma Europe Ltd
name: General Manager
role: STUDY_DIRECTOR
References:
Clinical trial NCT03185598: MACE and First Operating Room Systolic Blood Pressure in Patients Undergoing Non-cardiac Surgery Implications for the Hypertension Threshold
Official title: MACE and First Operating Room Systolic Blood Pressure in Patients Undergoing Non-cardiac Surgery Implications for the Hypertension Threshold
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Adverse Cardiac-cerebral-kidney Event
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 90342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 90342 eligible surgeries among 71164 unique patients included

Brief summary: To find the threshold of First operating room SBP above which MACE risk increases.

Detailed description: To find the threshold of First operating room SBP above which MACE risk increases. By reviewing data from 2012-2017 in PKU first hospital.

Eligibility criteria: Inclusion Criteria:

* 18-100yr non-cardiac surgery

Exclusion Criteria:

* missing data file

Primary outcomes:
measure: MACE
timeFrame: 30 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00659698: Effect of an Artificial Pancreas in Patients Undergoing Hepatic Resection
Official title: Prevention for Surgical Site Infection After Hepatic Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Diseases
Keywords: surgical
site
infection
Lead sponsor: Kochi University
Sponsor class: OTHER
First posted: 2008-04-16
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study evaluated that strict control of perioperative blood glucose following hepatic resection by using an artificial pancreas would improve postoperative surgical site infection.

Detailed description: This study recruited 70 patients undergoing elective hepatic resection for liver diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system. We prospectively divided patients into two groups: one for whom glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale and another that received programmed infusions of insulin determined by the control algorithm of the artificial pancreas.

Eligibility criteria: Inclusion Criteria:

* This study recruited 70 patients undergoing elective hepatic resection for liver diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system.

Exclusion Criteria:

* weight loss greater than 10% during the previous 6 months, signs of distant metastasis, and respiratory, renal, or heart disease

Primary outcomes:
measure: the incidence of surgical site infection
timeFrame: 30th postoperative day
Secondary outcomes:
measure: the incidence of hypoglycemia and cost during the hospitalization
timeFrame: during the hospitalization
Other outcomes:
Locations:
city: Nankoku-City
country: Japan
facility: Kochi Medical School
state: Kochi
Study officials:
affiliation: Kochi Medical School
name: Takehiro Okabayashi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00971698: The Spleen in Sickle Cell Anemia and Sickle Cell Thalassemia
Official title: The Spleen in Sickle Cell Anemia and Sickle Cell Thalassemia. Clinical Presentation and Follow up. Splenectomy, Indications and Complications.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Anemia
Thalassemia
Keywords: Splenectomy
Thrombocytosis
Infections
Spleen
Sickle Cell Thalassemia
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2009-09-04
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Two groups of patients: 25 patients with homozygous Sickle Cell Anemia and 25 patients with Sickle Cell Thalassemia

Brief summary: The spleen in Sickle Cell Anemia and Sickle Cell Thalassemia is usually enlarged in the first years of life but the immune protection provided is considered insufficient. In homozygous Sickle cell patients the spleen usually developed recurrent infarcts and after the first decade of age become fibrotic. Acute splenic sequestration is also frequent in those patients and this is considered as an indication for splenectomy.

In comparison in Sickle cell thalassemia patients, hypersplenism is more frequent.

The purpose of this study is to compare the clinical and laboratory issues related to the spleen in two groups of Sickle cell patients.

Detailed description: Clinical and laboratory characteristics related to the spleen in SCA patients will be studied.

Two groups of patient will be compared, a group of Sickle cell patients (Homozygous) and a second group of patients with Sickle cell beta thalassemia.

In those patients that splenectomy was performed the incidence of infections will be recorded besides the indications for splenectomy and the incidence of thrombotic events or thrombocytosis.

Eligibility criteria: Inclusion Criteria:

* All the patients followed up at the Pediatric Hematology Unit

Exclusion Criteria:

* Patients lost from follow up of with insufficient data

Primary outcomes:
measure: Clinical events and abnormal laboratory results
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Study officials:
References:
Clinical trial NCT03727698: Prospective Evaluation of Radiotherapy Using Magnetic Resonance Image Guided Treatment
Official title: Prospective Evaluation of Radiotherapy Using Magnetic Resonance Image Guided Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 200
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To assess delivery of radiotherapy on the MR Linac for multiple tumour sites
Primary purpose: TREATMENT

Brief summary: The purpose of PERMIT is to collect information on the treatment of radiotherapy patients using a new radiotherapy machine that includes magnetic Resonance (MR) imaging (MR linac) to guide treatment. The aim is to use this information to support the introduction of MR Linac into clinical practice.

PERMIT will collect details on patients treated on the MR linac plus details on their side effects and other outcomes. This information plus technical and imaging information will be combined with information from other centres using this machine. By doing so this will help us learn how best to use the MR Linac in the future and design new radiotherapy protocols


Eligibility criteria: Inclusion Criteria:

1. Radiotherapy treatment suitable to be delivered on the MR Linac.
2. Patient provides written, informed consent and/or authorization.
3. Patients between the ages of 5 and under 16 years old may enter protocol with parental/guardian consent.

Exclusion Criteria:

1. Contra-indications to MR imaging.
2. Radiotherapy not suitable for delivery on the MR Linac e.g. those with extended field lengths (exceeding 20 cm).

Primary outcomes:
measure: Technical feasibility of undertaking MRL based radiotherapy at multiple clinical sites: The percentage of treatment fractions delivered successfully on the MR linac
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Marsden NHSFT
Study officials:
References:
Clinical trial NCT02114398: Physiotherapy Efficiency on Child Asthma
Official title: Physiotherapy Efficiency With Caycedian Sophrology on Child Asthma: Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child
Asthma Crisis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 74
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study aim is to compare usual asthma crisis treatment of hospitalized children with usual treatment associated to sophrology.


Eligibility criteria: Inclusion Criteria:

* child (6 to 17 years old)
* hospitalized in pediatric unit for asthma crisis

Exclusion Criteria:

* patient who can't participate because of his healthcare (resuscitation...)
* impossibility to measure Peak Expiratory Flow (PEF)

Primary outcomes:
measure: Peak Expiratory Flow (PEF)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Study officials:
affiliation: UH Montpellier
name: Pascal AMEDRO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Romieu H, Charbonnier F, Janka D, Douillard A, Macioce V, Lavastre K, Abassi H, Renoux MC, Mura T, Amedro P. Efficiency of physiotherapy with Caycedian Sophrology on children with asthma: A randomized controlled trial. Pediatr Pulmonol. 2018 May;53(5):559-566. doi: 10.1002/ppul.23982. Epub 2018 Mar 1.
Clinical trial NCT01907698: Effect of Vaginal Intercourse on Spontaneous Labour at Term
Official title: Effect of Vaginal Intercourse on Spontaneous Labour at Term- A Randomized Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spontaneous Labour Onset
Vaginal Intercourse at Term
Keywords: vaginal intercourse
labour
term pregnancy
Lead sponsor: Hospital de Santa Maria, Portugal
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women attending to antenatal appointment in our Obstetric Unit

Brief summary: Vaginal intercourse to promote labour onset is biologically plausible. Oxytocin release during female orgasm, cervix mechanical stimulation and the effect of semen's prostaglandins are possible involved mechanisms. The investigators propose to evaluate the effect of vaginal intercourse on spontaneous labour at term.


Eligibility criteria: Inclusion Criteria:

* Term pregnancy
* Singleton pregnancy
* Cephalic presentation
* No previous cesarean section
* Irrelevant obstetric history
* Surveiled pregnancy without complications

Primary outcomes:
measure: Spontaneous labour onset at term
timeFrame: Spontaneous labour onset between 37 and 42 weeks of pregnancy
Secondary outcomes:
measure: Gestational age at delivery
timeFrame: Gestational age at delivery (between 37 and 42 weeks of pregnancy)
measure: Mode of delivery
timeFrame: Mode of delivery (vaginal or cesarean delivery) up to 42 weeks of pregnancy
measure: Interval between recruitment and delivery
timeFrame: number of days between patients study recruitment and delivery (maximum period of 28 days - between 38 and 41/0-6 weeks/days of pregnancy)
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Hospital de Santa Maria
Study officials:
affiliation: Hospital de Santa Maria
name: Catarina Castro, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castro C, Afonso M, Carvalho R, Clode N, Graca LM. Effect of vaginal intercourse on spontaneous labor at term: a randomized controlled trial. Arch Gynecol Obstet. 2014 Dec;290(6):1121-5. doi: 10.1007/s00404-014-3343-0. Epub 2014 Jul 18.
Clinical trial NCT01720498: The Effect Site Concentration of Remifentanil for Preventing QTc Interval Prolongation During Intubation Under Propofol-remifentanil Anesthesia in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Surgery With Endotracheal Intubation
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2012-11-02
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in elderly patients

Detailed description: The increase of Corrected QT (QTc) interval is associated with age. It is known that most inhalation anesthetics or intravenous anesthetics can influence the QTc. In addition, tracheal intubation during induction can stimulates sympathetic activity, which, as a results, prolong the QTc interval. Therefore, the aim of study is to find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in elderly patients.

Eligibility criteria: Inclusion Criteria:

* ≥ 65 years ASA class I-II who received surgery with endotracheal intubation

Exclusion Criteria:

* emergency surgery
* electrocardiography abnormality
* hypertension
* diabetes mellitus
* end stage renal disease
* moderate to severe cardiac disease
* moderate to severe liver dysfunction

Primary outcomes:
measure: The effect site concentration for preventing QTc interval prolongation
timeFrame: 2 min
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
name: So Yeon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00368498: A Trial to Evaluate the Loading Dose Required to Achieve Therapeutic Serum Teicoplanin Concentration Timely
Official title: A Randomized Single Blind Parallel Control Trial to Evaluate the Loading Dose Required to Achieve Therapeutic Serum Teicoplanin Concentration Timely
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Staphylococcal Infections
Keywords: teicoplanin
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2006-08-24
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
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 whether the standard dosage of teicoplanin is adequate to produce timely the trough level \> 10 mg/L, which is considered to be effective in the treatment of methicillin-resistant Staphyllococcus aureus (MRSA) bacteremia.

Detailed description: In our hospital, the minimum inhibitory concentration of 100 MRSA isolates in 2003 for teicoplanin is 2 mg/L. Due to its time-dependant bacteriocidal effect, the trough level should exceed 10 mg/L, particularly in the elderly, for MRSA bacteremia. However, it is known that standard dosage of teicoplanin often produces inadequate serum trough levels, and MRSA infections may recurred. Therefore, to evaluate the loading dose required to achieve therapeutic concentration timely, we compare the trough levels between those given standard dose (6 mg/Kg) and those given increasing loading dose (12 mg/Kg). We also monitor the occurrence of adverse drug effects and clinical response.

Eligibility criteria: Inclusion Criteria:

* Patients over 16 years of age who have blood culture-proven MRSA bacteremia and did not receive teicoplanin or vancomycin in the previous one month are enrolled.

Exclusion Criteria:

* Those who are allergic to teicoplanin or who have the need to use higher doses, 12 mg/kg/dose, such as endocarditis, osteomyelitis, septic arthritis and burn patients, are excluded.

Primary outcomes:
measure: the proportion of the trough level attaining 10 mg/L at different timing
Secondary outcomes:
measure: the occurrence of adverse drug effects
measure: the correlation between the trough level and the patients' characteristics
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Shan-Chwen Chang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: