louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01025375: Effects of Inulin on Satiety and Food Intake
Official title: Effects of Inulin on Satiety and Food Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: overweight
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-12-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To assess the effect of inulin on appetite profile ratings, food intake and satiety hormones.

Detailed description: Based upon a slower digestion and the fermentation in the intestinal tract, food containing soluble dietary fibres, such as inulin, is hypothesized to be more satiating, and to limit energy intake, in humans. Does supplementation of inulin (at 2 dosages) versus placebo over 13 consecutive days in normal to overweight men and women, lead to an increase in satiety, a reduction in food intake and stronger postprandial increases in GLP-1 and PYY?

Eligibility criteria: Inclusion Criteria:

* age between 18 and 60 years
* BMI between 23 and 28 kg/m2
* dietary unrestraint (TFEQ: F1\<9)

Exclusion Criteria:

* age under 18 and above 60 years
* BMI under 23 and above 28 kg/m2
* dietary restraint (TFEQ: F1\>9)
* use of medication
* pregnant or breastfeeding

Primary outcomes:
measure: food intake
timeFrame: on testday 0 and 13
Secondary outcomes:
measure: appetite profile ratings
timeFrame: on test day 0, 8 and 13 (at 16 time points)
measure: satiety hormones (GLP-1 and PYY)
timeFrame: on test day 0 and 13 (at 9 time points
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
affiliation: NUTRIM
name: Klaas R Westerterp, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03386175: Efficiency of Negative Pression Therapy With Instillation in the Debridement of Wound
Official title: Efficiency of Negative Pression Therapy With Instillation in the Debridement of Wound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wound
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 20
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 with wound and fibrin more than 70%

Brief summary: the aim of the study is to evaluate the efficiency of the therapy with negative pression (TPN) and instillation in the debridement of chronic wound

Detailed description: it is an observation study with only the aim to evaluate the percentage of fibrin before and after the specific treatment of TPN

Eligibility criteria: Inclusion Criteria:

* wound with debridement

Exclusion Criteria:

-

Primary outcomes:
measure: percentage of fibrine
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University hospital
Study officials:
References:
Clinical trial NCT01486875: Observational Study of Safety of NovoMix® 30 Treatment for Type 2 Diabetes
Official title: NovoMix® Start - A Multicentre, Open Label, Non-randomised, Non-interventional, Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix 30® Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 1155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: After the physician has decided to initiate biphasic insulin aspart 30 therapy, any insulin-naïve patient with type 2 diabetes mellitus in need of improved metabolic control, as judged by the treating physician, will be able to participate

Brief summary: This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes

Primary outcomes:
measure: Incidence of serious adverse drug reactions (SADRs)
timeFrame: Week 26
measure: Incidence of major hypoglycaemic events
timeFrame: Week 26
Secondary outcomes:
measure: Number of all hypoglycaemic events
timeFrame: In the 4 weeks prior to week 12 and week 26, respectively
measure: HbA1c (glycosylated haemoglobin A1c)
timeFrame: Week 26
measure: Fasting Plasma Glucose (FPG)
timeFrame: Week 26
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Berntorp K, Haglund M, Larsen S, Petruckevitch A, Landin-Olsson M; Swedish BIAsp Study Group. Initiation of biphasic insulin aspart 30/70 in subjects with type 2 diabetes mellitus in a largely primary care-based setting in Sweden. Prim Care Diabetes. 2011 Jul;5(2):89-94. doi: 10.1016/j.pcd.2011.02.003. Epub 2011 Mar 26.
Clinical trial NCT04328675: Registration Study of Amyotrophic Lateral Sclerosis (ALS) in Mainland China
Official title: Registration Study of Natural History and Clinical Characteristics of Amyotrophic Lateral Sclerosis (ALS) in Mainland China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 4752
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who meet the criteria will be enrolled from multi-centers in mainland China.

Brief summary: A multi-center registration study of natural history and clinical characteristics of ALS in mainland China

Detailed description: Amyotrophic lateral sclerosis (ALS) is a rapidly progressive neurodegenerative disease of unknown etiology that is currently incurable. This study is a national multi-center registration study. The study collects general information of ALS patients including medical history, disease characteristics, clinical treatment data, and patient information for different visits in different centers. The aim of the study is: a) describe the distribution of ALS in mainland China(explore the differences in the number of ALS at different times, different regions, and different populations) and further find the reasons that affect the distribution of ALS, b) study the development of ALS in mainland China and the corresponding changes in the characteristics of the disease, c) explore factors that influence the prognosis of ALS.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of laboratory-supported probable, probable, or definite ALS according to EI Escorial diagnostic criteria
* Age: 18-70 years

Exclusion Criteria:

* Refuse to cooperate or reject the informed consent

Primary outcomes:
measure: Effective Survival
timeFrame: through study completion, an average of 3 month
Secondary outcomes:
measure: Overall Survival
timeFrame: through study completion, an average of 3 month
measure: Rate of disease progression
timeFrame: through study completion, an average of 3 month
measure: Rate of Weight decline
timeFrame: through study completion, an average of 3 month
measure: Rate of BMI decline
timeFrame: through study completion, an average of 3 month
measure: Rate of Forced Vital Capacity (FVC)
timeFrame: through study completion, an average of 3 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Dongsheng Fan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: He J, Fu JY, Chen L, He J, Dang J, Zou Z, Ma S, Li N, Fan D. Multicentre, prospective registry study of amyotrophic lateral sclerosis in mainland China (CHALSR): study protocol. BMJ Open. 2020 Dec 4;10(12):e042603. doi: 10.1136/bmjopen-2020-042603.
Clinical trial NCT01229475: Stepwise Approach Versus Linear Ablation in Patients With Recurrence of Persistent Atrial Fibrillation
Official title: Stepwise Approach Versus Linear Ablation for Repeat Procedure in Patients With Recurrence of Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Recurrence
Keywords: Atrial fibrillation
recurrence
repeat procedure
linear ablation
stepwise approach
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2010-10-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Catheter ablation of persistent atrial fibrillation (AF) remains a challenging procedure. Even in experienced centres, repeat interventions are necessary in up to 70 of patients to achieve sinus rhythm at a long-term follow-up.

While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for the ablation of paroxysmal and persistent AF ablation, different additional ablation strategies are used to achieve a modification of the substrate that perpetuates the arrhythmia: linear lesions (anterior and roof lines) or ablation of complex fractionated atrial electrograms (CFAE). In the stepwise approach PVI, CFAE ablation and/or LL are combined according to the presenting arrhythmia during procedure.

The aim of the study is to determine whether there is a difference in terms of freedom from arrhythmia between a stepwise approach and a linear ablation for repeat procedure in patient with recurrence of persistent atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Patients with recurrence of symptomatic persistent atrial fibrillation after at least one ablation procedure,
* with the last ablation procedure at least 3 months ago.
* at least one unsuccessful attempt of antiarrhythmic drug
* oral anticoagulation for at least 4 weeks prior to ablation

Exclusion Criteria:

* LA thrombus

Primary outcomes:
measure: Freedom from atrial arrhythmia
Secondary outcomes:
measure: Procedural and safety data
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
Study officials:
affiliation: Deutsches Herzzentrum München
name: Isabel Deisenhofer, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum München
name: Sonia Ammar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03352375: Positive Pressure Ventilation Through a Laryngeal Mask Airway in Pediatrics
Official title: Can Positive Pressure Ventilation be Provided Through a Laryngeal Mask Airway in Pediatrics During Laparoscopic Inguinal Hernia Repair?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric
Anesthesia
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All pediatric patients, who were scheduled to undergo laparoscopic surgery
Primary purpose: TREATMENT

Brief summary: The investigators aimed to investigate effects of intubation and laryngeal mask airway usage in pediatrics during laparoscopic inguinal hernia repair.

Detailed description: Considering blood gas analysis, end tidal carbon dioxide measurements and airway changes, the investigators aimed to investigate effects of intubation and laryngeal mask airway usage in pediatrics during laparoscopic inguinal hernia repair in this study.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I, being scheduled to undergo laparoscopic inguinal hernia.

Exclusion Criteria:

* Patients, who did not want to participate, patients with severe airway deformities, patients having increased gastroesophageal regurgitation risk, reactive airway hiatal hernia, peripheric vascular disease, mental retardation, neuropsychiatric illness or an lung infection during the last 6 weeks.

Primary outcomes:
measure: end tidal carbon dioxide
timeFrame: up to 200 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sisli Hamidiye Etfal Training and Research Hospital
name: Canan Tulay Isil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sinha A, Sharma B, Sood J. ProSeal as an alternative to endotracheal intubation in pediatric laparoscopy. Paediatr Anaesth. 2007 Apr;17(4):327-32. doi: 10.1111/j.1460-9592.2006.02127.x.
Clinical trial NCT02084875: A Study To Evaluate The Effect Of Food On The Behavior Of Tofacitinib Modified Release 11 Milligram Tablets In Healthy Western And Japanese Volunteers
Official title: A Phase 1, Randomized, Open Label, Single Dose, 2-Period Crossover Study To Evaluate The Effect Of Food On The Pharmacokinetics Of Tofacitinib Modified Release (MR) 11 Mg Tablets In Healthy Western And Japanese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Food effect
pharmacokinetic
healthy volunteer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-03-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation in 24 healthy volunteers when taken after eating a high fat meal (the effect of food). This will be compared to the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation when taken after a 10 hour fast.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers and/or healthy females volunteers of non-childbearing potential who are 18 to 55 years of age;
* Healthy volunteers who are of Japanese or Western descent;
* Healthy volunteers with no evidence of active or latent or inadequately treated tuberculosis.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
* Clinically significant infections within the past 3 months

Primary outcomes:
measure: Area under the curve from time zero to infinity
timeFrame: 48 hours post dose
measure: Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration
timeFrame: 48 hours post dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 48 hours post dose
Secondary outcomes:
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 48 hours post dose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 48 hours post dose
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05155475: Endoscopic Ultrasound Evaluation of the Common Bile Duct in Patients With Obstructive Jaundice Due to Bilio-pancreatic Malignancies (ECCO Trial)
Official title: Endoscopic Ultrasound Evaluation of the Common Bile Duct in Patients With Obstructive Jaundice Due to Bilio-pancreatic Malignancies: a Multicenter Prospective Study (ECCO Trial)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Jaundice
Bilio-pancreatic Tumor
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2021-12-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years old, with jaundice

Brief summary: To assess the size of the common bile duct in a large cohort of patients with jaundice following a malignant tumor of the head of the pancreas or the distal bile duct receiving a diagnostic EA for biopsy and / or for evaluation of tissue resectability.


Eligibility criteria: Inclusion Criteria:

* Patients with jaundice and an injury to the head of the pancreas recommended for EUS-guided tissue acquisition or staging
* Patients with jaundice and distal CBD lesion suggestive of cholangiocarcinoma or Vater's ampulla carcinoma recommended for EUS-guided tissue acquisition or staging
* Serum bilirubin level ≥ 3 mg / dl
* Age ≥ 18 years old
* Subject affiliated or beneficiary of a social security scheme.
* Subject having been informed of this study and having given his no objection

Exclusion Criteria:

* Presence of altered anatomy due to previous gastric surgery (Billroth II or Roux-en-Y anastomosis)
* Sphincterotomy performed previously, plastic biliary stent or metal stent placement
* Percutaneous drainage of the bile ducts performed previously
* Pregnant, breastfeeding or parturient woman
* Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; hospitalized without consent.

Primary outcomes:
measure: Evaluation of the common bile duct size
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Jean Mermoz
Study officials:
References:
Clinical trial NCT02618759: Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Mild to Moderate Plaque Psoriasis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Mild to Moderate Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2015-12-01
Enrollment: 119
Sex: ALL
Minimum age (years): 12
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 evaluate the therapeutic efficacy and safety of DSXS compared to a Placebo (vehicle) in patients with mild to moderate plaque psoriasis.

Detailed description: To evaluate the therapeutic efficacy and safety of dsxs topical spray, 0.15% (Taro Pharmaceuticals, U.S.A., Inc.) compared to a Placebo (vehicle) spray (Taro Pharmaceuticals, U.S.A., Inc.) in patients with mild to moderate plaque psoriasis.

Eligibility criteria: Inclusion Criteria:

* male and non-pregnant females, 12 years of age or older, with a confirmed diagnosis of mild to moderate plaque psoriasis

Exclusion Criteria:

* patient is\< 12 years old.

Primary outcomes:
measure: Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2
timeFrame: 28 Days
measure: Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2
timeFrame: 28 Days
Secondary outcomes:
measure: Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)
timeFrame: 28 Days
measure: Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)
timeFrame: 28 Days
measure: Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)
timeFrame: 28 Days
measure: Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)
timeFrame: 28 Days
Other outcomes:
Locations:
city: Hawthorne
country: United States
facility: Taro Pharmaceuticals USA Inc.
state: New York
Study officials:
affiliation: http://www.novumprs.com/contact
name: Novum Pharmaceutical Research Services
role: STUDY_CHAIR
References:
Clinical trial NCT01781559: Bioefficacy of Phenolic Acids
Official title: Effect of Phenolic Acids on the Human Vasculature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-02-01
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective is to demonstrate the effect of phenolic acids on endothelial function.


Eligibility criteria: Inclusion Criteria:

* Healthy, Men and women
* Subjects with endothelial dysfunction defined as a basal brachial artery flow-mediated dilatation (FMD) measurement between 3% and 8% at screening

Exclusion Criteria:

* Any food allergy
* Abnormal blood pressure defined as follow: systolic \<100 or \>160 mmHg and diastolic \<50 or \>100mmHg
* Pregnancy or lactating women
* Regular consumption of cholesterol-lowering or antihypertensive medication
* Smokers
* Inability to restrain from caffeine/tea and alcohol for 12hrs prior to study visits (intake1 day before screening measurements (and 1 day before each visit)
* Not restrain the intake of multivitamin-tablets and other supplemental compounds 10 days before the study start and throughout the study.
* Excessive alcohol intake defined as \> 280 g per week for men and \>210g per week for women

Primary outcomes:
measure: Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment
timeFrame: After 1 hour
Secondary outcomes:
measure: Change from predose in blood pressure at 0.5h
timeFrame: After 30 min
Other outcomes:
Locations:
city: Perth
country: Australia
facility: School of Medicine and Pharmacology - University of WA
Study officials:
affiliation: School of Medicine and Pharmacology - University of WA
name: Kevin Croft, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02241759: Study of the Electrocardiographic Effects of TA-8995
Official title: A Phase I, Single-Centre, Randomised, Placebo and Positive- Controlled, Parallel-Group Study of the Electrocardiographic Effects of TA-8995 in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidaemia
Lead sponsor: Xention Ltd
Sponsor class: INDUSTRY
First posted: 2014-09-16
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study in healthy males and females to see if a high single dose of TA-8995 has an effect on the ECG QTcF interval.


Eligibility criteria: Inclusion Criteria:

* Healthy male or females of non-child bearing potential

Exclusion Criteria:

* Receiving any other drug therapy
* Clinically significant medical history
* Abnormal ECGs or vital signs

Primary outcomes:
measure: Change from baseline in QT interval corrected for heart rate (QTc) for TA-8995 versus placebo
timeFrame: 4 days
Secondary outcomes:
measure: Relationship between plasma levels of TA-8995 and the QTcF effect
timeFrame: 4 days
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit Ltd
Study officials:
affiliation: Covance
name: Ashley Brooks
role: PRINCIPAL_INVESTIGATOR
References: