louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02440633: A Phase 1,Open -Label Study to Assess the Absorption, Metabolism and Excretion of 14C-OPS-2071 Following a Single Oral Dose to Healthy Male Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacterial Enteritis
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-12
Enrollment: 8
Sex: MALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To obtain absorption, metabolism and excretion data for parent drug and any metabolites.


Eligibility criteria: Inclusion Criteria:

* Healthy males
* Body mass index (BMI) between 18.5 and 25.0 kg/m2, inclusive
* Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

Exclusion Criteria:

* Subjects who have a significant history of alcoholism or drug/chemical abuse, as determined by the Investigator.
* Subjects who smoke, or who have used nicotine within 3 months prior to screening..
* Subjects who have a significant history of drug allergy, as determined by the Investigator.
* Subjects who have any clinically significant abnormal physical examination finding.
* Subjects who have any clinically significant medical history, as determined by the Investigator.
* Subjects who are exposed to radiation as a result of their occupation.
* Subjects who have had an X ray or CT scan, or who have participated in any trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.

Primary outcomes:
measure: The Amounts of Radioactivity Excreted in Urine and Faeces
timeFrame: up to144-168h postdose.
measure: Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood
timeFrame: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.
measure: AUC of OPS-2071 in Plasma
timeFrame: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
Study officials:
affiliation: Small Global, Division of New Product Evaluation and Development
name: Yoshitaka Kotobuki
role: STUDY_DIRECTOR
References:
Clinical trial NCT00460733: SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture.
Official title: Local (Brazil) Study, Multicenter, Opened, Comparative, Randomized, With Parallel Groups, Phase IV, in Post Menopausal Woman With Colles' Fracture of the Risedronate Sodium Usage in the Consolidation and in the Callus of the Colles'Fracture.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colles' Fracture
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Procter and Gamble
First posted: 2007-04-16
Enrollment: 141
Sex: FEMALE
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 efficacy and safety of risedronate sodium (Actonel®) after a wrist fracture in postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* Women with description of 2 or more years of Menopause;
* T-score \<= -2.0 sd;
* Confirmed colles'fracture;
* Independent for the march (preserved ambulatorial ability);

Exclusion Criteria:

* Co-morbidities;
* Regular use of corticosteroids or other anti-resorptive drug in the last year;
* Use of drugs that can affect the calcium metabolism;
* Hypersensitivity to risedronate;
* Previous wrist or forearm fracture;
* Hypocalcemia;
* Renal insufficiency;
* Rheumatic disease;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Body mineral density of the 33% radius region and of the UD radius region
timeFrame: after 90 days of treatment
Secondary outcomes:
measure: Body mineral density of the 33% radius region and of the UD radius region
timeFrame: after 180 days of treatment
measure: Size of callus obtained through Rx of the fracture site.
timeFrame: from the beginning up to the end of the study
measure: Safety: Adverse events occurrence.
timeFrame: from the inform consent signature up to the end of the study
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT00755833: Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months
Official title: A Prospective, Multicentre, Open Label, Un-controlled , Observational, 12-month Study in Subjects Using: NovoMix® 50 (Biphasic Insulin Aspart 50) for Treatment of Type 2 Diabetes Mellitus in Slovenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-09-19
Enrollment: 270
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: Type 2 diabetes patients from both general and speciality practice settings who have been deemed appropriate to receive NovoMix® 50 as new treatment and as part of routine out-patient care by the prescribing physician.

Brief summary: This study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective is also to observe the different regimes of starting and maintaining the treatment with NovoMix® 50 during one year.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes treated with biphasic human insulin with or without metformin
* Inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the physician's opinion, benefit from treatment with NovoMix® 50

Exclusion Criteria:

* Subjects with diagnosed type 1 diabetes mellitus
* Subjects treated with short acting or intermediate acting human insulin or any insulin analogue
* Subjects who are unlikely to comply with study description, e.g. uncooperative attitude, inability to come for regular visits
* Subjects with a hypersensitivity to biphasic insulin aspart 50 (NovoMix® 50 )or to any of the excipients
* Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months

Primary outcomes:
measure: Change in HbA1c
timeFrame: At 0, 3, 6, 9, 12 months
Secondary outcomes:
measure: Percentage of subjects achieving target HbA1c
timeFrame: At 0, 3, 6, 9, 12 months
measure: Change in FPG (fasting plasma glucose)
timeFrame: At 0, 3, 6, 9, 12 months
measure: Change in PPG (postprandial glucose)
timeFrame: At 0, 3, 6, 9, 12 months
measure: Change in number of hypoglycaemic events
timeFrame: At 0, 3, 6, 9, 12 months
measure: Change in insulin presentation
timeFrame: At 0, 3, 6, 9, 12 months
measure: Dose and number of injections
timeFrame: At 0, 3, 6, 9, 12 months
measure: Number of ADRs (adverse drug reaction)
timeFrame: At 0, 3, 6, 9, 12 months
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04109833: Early Antibiotic Therapy and Vaccination
Official title: Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vaccination Reaction
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 20
Sex: ALL
Minimum age (years): 24
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: preterm infants with gestational age between 24+0 and 28+6 weeks of gestation

Brief summary: Neonatal Sepsis is one of the most common causes of death in preterm infants. Therefore, up to 80% of very low birth weight infants receive antibiotic therapy in their first week of life. Antibiotic therapy is one of the most important influencing factors for the establishment of the intestinal microbiome, which in turn modulates neonatal immune development. In this pilot study, it will be investigated, if antibiotic therapy in the first week of life influences the vaccination response of preterm infants.

Detailed description: The aim of the study is to compare antibody titers against Hepatitis B, Polio, Pertussis, Haemophilus influenza B, Tetanus, Diphteria and Pneumococcus in very low birth weight infants (VLBWI) infants who received antibiotic therapy in their first week of life and who did not. In this pilot study, 20 VLBWI infants will be included (10 per group). Infants will be matched fo age and gender.

Eligibility criteria: Inclusion Criteria:

* born at University Hospital Tübingen
* at least one dose of antibiotics within the first week of life

Exclusion Criteria:

* genetic disorders
* chronic infections
* hematological disorders
* immunoglobulins within the first 60 days of life
* immunological disorders
* infants from Hepatitis B positive mothers

Primary outcomes:
measure: vaccination reaction
timeFrame: 7 months
Secondary outcomes:
measure: Microbiome composition
timeFrame: 7 months
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital
state: Baden-Württemberg
Study officials:
affiliation: Department for Neonatology at University Hospital Tübingen
name: Natascha Köstlin-Gille, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00914433: Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Inhaled TPI 1100 in Healthy Volunteers
Official title: A Phase 1,Randomized, Double--blind, Placebo-controlled Study Assessing the Safety and Tolerability, the Pharmacodynamics and Pharmacokinetics of Single-ascending and Repeated Doses of Inhaled TPI 1100 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Syntara
Sponsor class: INDUSTRY
First posted: 2009-06-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will look at the safety and tolerability of TPI 1100 in healthy volunteers and look at pharmacodynamic (PD) effect on mRNA expression of PDE 4B/D \& 7A in blood and in sputum.

Detailed description: Study was not initiated and terminated before start-up.

Eligibility criteria: Inclusion Criteria:

* Healthy, male or female volunteers aged 18 to 55 years inclusive
* Screening/baseline FEV1 greater than 90% predicted,
* Body mass index (BMI) of 19 to 28 inclusive,
* Clinical laboratory values and/or vital signs within normal reference ranges or not considered clinically significant by the Investigator

Exclusion Criteria:

* Airways or systemic conditions that might affect respiratory function, including but not limited to clinically significant cardiac problems,
* Breast-feeding or pregnancy,
* Positive tests for smoking tobacco, alcohol, hepatitis B-surface antigen, hepatitis C antibody, and HIV at screening,
* History of serious adverse reaction to any drugs,

Primary outcomes:
measure: Airway-specific and general safety and tolerability.
timeFrame: 24 hours post-dose and on Day 4
Secondary outcomes:
measure: Effect on mRNA
timeFrame: 24 hrs post-dose and on Day 4
Other outcomes:
Locations:
Study officials:
affiliation: Topigen Pharmaceuticals Inc.
name: Pageau
role: STUDY_DIRECTOR
References:
Clinical trial NCT02113033: VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
Official title: VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure With Reduced Ejection Fraction
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2014-04-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Equilia VNS device
Primary purpose: TREATMENT

Brief summary: The purpose of the VANGUARD study is to demonstrate the safety of Vagal Nerve Stimulation for the treatment of congestive heart failure with reduced ejection fraction, and to report secondary measures of efficacy.


Eligibility criteria: Inclusion Criteria:

1. Left ventricular dysfunction of ischemic or idiopathic dilated cardiomyopathy etiology, characterized by LVEF \< 40%
2. Chronic heart failure with symptoms characterized by NYHA functional class II or III at the time of enrollment despite optimal drug regimen
3. Optimal drug regimen as defined in the current European guidelines
4. Sinus rhythm, with spontaneous heart rate ≥ 60bpm at the time of enrollment
5. Signed and dated informed consent

Main Exclusion Criteria:

* Patient implanted with or eligible to cardiac pacing as per current guideline
* Risk for neck surgery in the electrode zone within a year after enrollment
* Patient with right carotid artery stenosis
* Symptomatic hypotension
* History of peptic ulcer disease or upper gastrointestinal bleeding
* Asthma, severe COPD, or severe restrictive lung disease
* Advanced Diabetes Mellitus
* Recent acute myocardial infarction, coronary artery surgery or revascularization (or already planned)
* Recent cerebro-vascular event
* Significant valvulopathy
* Advanced Renal failure
* Previous heart transplant or current LVAD device therapy
* Life expectancy \< 1 year for non-cardiac cause
* Patient included in another clinical study that could confound the results of this study
* Inability to understand the purpose of the study or to perform the procedures of the study
* Unavailability for scheduled follow-up
* Age of less than 18 years or under guardianship
* Pregnancy

Primary outcomes:
measure: The primary outcome measure is the freedom from Serious Adverse Device Effects, defined as the number of patients without SADEs.
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: UCL St Luc
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Rennes
country: France
facility: CHRU Hôpital Pontchaillou
city: Toulouse
country: France
facility: CHU Rangueil
city: Oslo
country: Norway
facility: Rikshospitalet
city: Belgrade
country: Serbia
facility: Dedinje Cardiovascular Institute
Study officials:
affiliation: HEGP - Paris, France
name: Albert Hagege, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00820833: Effect of Formula on Growth of Infants From Overweight or Obese Mothers
Official title: Effect of Protein Levels and Caloric Density on the Growth of Formula Fed Infants From Overweight or Obese Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Nutrition
Keywords: infant formula
obesity
growth
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2009-01-12
Enrollment: 230
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether infants, from overweight or obese mothers, fed a formula with proteins and calories different than a standard infant formula have a different growth


Eligibility criteria: Inclusion Criteria:

* healthy newborn infant
* birth weight between 2500g and 4800g
* singleton birth
* mother's BMI before pregnancy was between 26 and 25
* for the breastfeeding group: mother has elected to exclusively breastfeed her baby from birth to at least 6 months of age
* for the formula groups: mother has elected to exclusively formula feed her baby from 3 to 6 months of age
* having obtained signed informed consent of legal representative

Exclusion Criteria:

* body weight smaller than 5th percentile for that gestational age
* newborn whose mother has diabetes
* newborn whose mother has a drug dependence during pregnancy
* newborn currently participating in another trial

Primary outcomes:
measure: mean weight gain
timeFrame: 3 months
Secondary outcomes:
measure: blood test assessments; body composition, bone density
timeFrame: 9 months
Other outcomes:
Locations:
city: Temuco
country: Chile
facility: Departamento de Medicina Interna, University de la Frontera
Study officials:
affiliation: Universidad de La Frontera
name: Jaime Inostroza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Inostroza J, Haschke F, Steenhout P, Grathwohl D, Nelson SE, Ziegler EE. Low-protein formula slows weight gain in infants of overweight mothers. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):70-7. doi: 10.1097/MPG.0000000000000349.
Clinical trial NCT01351233: Evaluation of the Rotational Stability of The AcrySof Toric Intraocular Lens in the Capsular Bag in High Myopic Subjects
Official title: Evaluation of the Rotational Stability of The AcrySof Toric Intraocular Lens in the Capsular Bag in High Myopic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Cataract
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2011-05-10
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the stability and efficacy of The AcrySof Toric intraocular lens in the bag in high myopic subjects.

Detailed description: According to numerous estimations, 15% to 29% of patients with cataract have≥1.5 diopters (D) of refractive astigmatism. New toric IOL designs (Acrysof © toric IOL; Alcon), approved by the US Food and Drug Administration (FDA) at the end of 2005, have been found to be more stable and safety in the capsular bag in subjects with normal axis length of eye. Then,this study aims at the confirmation of the stability of The AcrySof Toric intraocular lens in the bag in high myopic subjects.Then we may find a more effective treatment for the high myopic patients with complicated cataract and sever cornea astigmatism .

Eligibility criteria: Inclusion Criteria:

1. Sphere more than -6.0D;
2. Cornea astigmatism from -1.0 D to -4.0D;
3. Clinical diagnosis of complicated cataract;
4. Ask for and accept refractive lens exchange surgery;
5. Accept AcrySof Toric intraocular lens .

Exclusion Criteria:

1. Other eye diseases induces impaired vision ,such as retinal detachment,keratoconus,pterygium,glaucoma,choroidal detachment,vitreous hemorrhage,congenital cataract,lens dislocation,anterior uveitis ,pupil deformation and so on;
2. Previous corneal or intraocular surgery;
3. Refuse surgery;
4. Refuse to use AcrySof Toric intraocular lens .

Primary outcomes:
measure: The position of IOL
timeFrame: 6 months
Secondary outcomes:
measure: refraction astigmatism
timeFrame: 6 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: Ayong Yu, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01394133: Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women
Official title: Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: HIV Infected
Keywords: HIV Infected Women
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2011-07-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected women will be selected from the primary care office

Brief summary: Data suggests that women taking drugs to treat human immunodeficiency virus (HIV) have higher amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The reason for this higher drug exposure has not yet been determined. The primary purpose of this study is to examine whether a pharmacokinetics (factors that determine the amount of drug in the body) of anti-HIV drugs change during different phases of the menstrual cycle in women and ultimately result in higher amounts of drug in the body compared with men. In other words, we plan to examine whether changes in sex hormones throughout the menstrual cycle affect the amount of anti-HIV drugs in HIV infected women. The antiretroviral drugs atazanavir, ritonavir, tenofovir and emtricitabine will be studied.


Eligibility criteria: Inclusion Criteria:

* HIV positive females between 21-40 years of age.
* Subjects must be receiving anti-HIV regimen consisting of tenofovir, emtricitabine, atazanavir, and ritonavir for a minimum of 4 weeks prior to the study.
* Subjects must have regular menstrual cycle (period), define at least 10 cycles a year, occurring approximately every 28 days+/- 4 days and cycle length varying by not more than 7 days.

Exclusion Criteria:

* Subjects can not be breast feeding, pregnant, or taking oral contraceptives (birth control pills) for at least 3 months prior to the study.
* Subjects may not have the intrauterine device (IUD), Mirena, in place to prevent pregnancy.

Primary outcomes:
measure: PK parameters
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: