louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00713271: Multiple Ascending Doses (MAD) of AZD3199 Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men
Official title: A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group, Single-centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD3199 (a B2-agonist) Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy male
tolerability
safety
inhalation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-11
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and tolerability of multiple once daily ascending doses of AZD3199 in healthy men


Eligibility criteria: Inclusion Criteria:

* BMI 19-30, weight 60-100 kg
* Non/ex-smokers, Non/ex-nicotine users

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically relevant abnormal findings at screening examinations
* Use of any prescribed or non-prescribed medication

Primary outcomes:
measure: Incidence and nature of Adverse Events
timeFrame: Before, during and after dosing
measure: Clinical significant abnormalities in ECG, pulse, blood pressure, lung function, temp, lab
timeFrame: Before, during and after dosing
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: Before, during and after dosing
measure: Potassium and lactate concentrations
timeFrame: Before, during and after dosing
measure: Tremor, palpitations, heart rate, QTc, pulse and blood pressure and FEV1
timeFrame: Before, during and after dosing
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Research Site
Study officials:
affiliation: AZ CPU Lund, Sweden
name: Gabriella Samuelsson Palmgren
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00427271: Aspirin and Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients
Official title: Aspirin and the Antiproteinuric Effect of Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients: a Randomized, Double-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus
Microalbuminuria
Keywords: aspirin
enalapril
microalbuminuria
glomerular filtration rate
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2007-01-29
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Research design: randomized, double-blind, placebo-controlled crossover study to evaluate the putative interference of low-dose aspirin (for 8 weeks) on enalapril antiproteinuric properties in microalbuminuric type 2 diabetes mellitus patients

Detailed description: Research design: randomized, double-blind, placebo-controlled crossover study Patients: Microalbuminuric (urinary albumin excretion \[UAE\]30-300 mg/d)type 2 diabetes mellitus patients without ischemic heart disease or peptic ulcer Aim:To evaluate the putative interference of low-dose aspirin (300 mg/d)for 8 weeks)on enalapril antiproteinuric properties in microalbuminuric type 2 diabetes mellitus patients Study protocol:Crossover randomization to 8 weeks of enalapril 10 mg/d plus aspirin (300 mg/d) or plus placebo, and a 6-week washout period. Measurement of UAE (immunoturbidimetry) and glomerular filtration rate (51Cr-EDTA), blood pressure and metabolic control at baseline and at the end of each period.

Statistical analyses: Bland\&Altman analyses for crossover trials.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus microalbuminuria

Exclusion Criteria:

* ischemic heart disease peptic disease

Primary outcomes:
measure: urinary albumin excretion
measure: glomerular filtration rate
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Aelgre
state: RS
Study officials:
affiliation: Programa de Pós-graduação em Ciências Médicas: Endocrinologia
name: Eduardo G Camargo
role: STUDY_DIRECTOR
References:
Clinical trial NCT06227871: A Retrospective Analysis of Pancreatic Injuries and Treatment Outcomes
Official title: A Retrospective Analysis of Pancreatic Injuries and Treatment Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Trauma
Pancreatic Duct Injury
Pancreas Necrosis
Pancreas Cyst
Pancreas; Fistula
Pancreas Abscess
Intra-Abdominal Abscess
Anastomotic Leak
Pancreas Injury
Keywords: Pancreatic trauma
Penetrating abdominal injury
Abdominal trauma
Lead sponsor: Kern Medical Center
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient's greater than 18 years old, with no history of pancreatic surgery who were hospitalized at Kern Medical Center from November 1st, 2019 to March 1st, 2023 after presenting to the institution's emergency department as tier 1 and 2 trauma activations following blunt or penetrating abdominal injury and were diagnosed with pancreatic injury during the same hospitalization.

Brief summary: The goal of this observational study is to compare the presentation, treatment, and outcomes in patients suffering traumatic pancreatic injuries from blunt or penetrating trauma.

The questions this study aims to answer are:

1. Does a statistically significant association exist between pancreatic injury grade and the following individual factors:

   * Mortality
   * Morbidity
   * Injury severity score
2. Is there an association between post-operative pancreatic complications and operation-specific intervention?
3. Does pancreatic injury score correlate with certain intra-abdominal organ injuries?

Participants meeting criteria are greater than 18 years old, with no history of pancreatic surgery who were hospitalized at Kern Medical Center after presenting to the institution's emergency department as tier 1 or 2 trauma activations following blunt or penetrating abdominal injury and were diagnosed with pancreatic injury during the same hospitalization.


Eligibility criteria: Inclusion Criteria:

* Hospitalized at Kern Medical Center after presenting to the institution's emergency department as a tier 1 and 2 trauma activation
* Hospitalized following blunt or penetrating abdominal injury
* Diagnosed with traumatic pancreatic injury during same admission

Exclusion Criteria:

* history of pancreatic surgery
* Iatrogenic pancreatic injuries

Primary outcomes:
measure: Complication occurrence
timeFrame: Up to 12 weeks postoperatively
Secondary outcomes:
measure: Associated intra-abdominal injuries
timeFrame: within 48 hours of admission
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Kern Medical Center
state: California
Study officials:
affiliation: Kern Medical Center
name: Amber Jones, DO, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02114671: A Study to Investigate the Phototoxic Potential of Faldaprevir
Official title: A Randomised, Assessor-blind, Placebo and Active Controlled, Parallel Group Study to Assess the Phototoxic Potential of Faldaprevir (Administered Orally, Once Daily) for 6 Days in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-04-15
Enrollment: 0
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: To investigate the potential of Faldaprevir to induce skin phototoxicity, immediate or delayed type, to UV light and visible light in healthy male and female subjects. To investigate the degree, wavelength dependency, severity, pigmentation and morphology of the phototoxic effects. The persistence of the phototoxic susceptibility will be explored following cessation of study medication. Within a sunscreen sub-study, the efficacy of commercially available high factor sunscreen will also be assessed in terms of its potential to prevent any phototoxic skin responses seen. The safety and tolerability of Faldaprevir will also be assessed.


Eligibility criteria: Inclusion criteria:

* Health male and female subjects with no clinically significant abnormality (according to the Investigator's assessment) identified from a complete medical history, physical examination, whole body skin assessment, 12-lead ECG, vital signs and clinical laboratory tests. In particular, there should be no evidence of abnormal photosensitivity
* Sun-reactive skin phototype I, II, or III

Exclusion criteria:

- Any relevant deviation from healthy conditions.

Primary outcomes:
measure: Number of subjects with drug related adverse events
timeFrame: 17 days
measure: Change in minimum erythema dose (MED) at each wavelength tested, before and during treatment. The change will be quantified by the phototoxic index at 24 hrs (delayed erythema) derived by dividing the baseline MED by that during treatment
timeFrame: 7 days
measure: Percentage of subjects with drug related adverse events
timeFrame: 17 days
Secondary outcomes:
measure: Degree of phototoxic effects by phototoxic index
timeFrame: 7 days
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: 1241.42.44001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT00362271: Aripiprazole and Effexor XR Drug Interaction Study
Official title: Effects of Aripiprazole on the Steady-State Pharmacokinetics of Venlafaxine in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Subjects
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2006-08-09
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this clinical research study is to learn whether aripiprazole has effect on the steady-state pharmacokinetics of venlafaxine in healthy subjects. The safety and tolerability of aripiprazole and venlafaxine co-administration will also be studied.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects, ages 18 to 45 (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.
* Body Mass Index (BMI) of 18 to 33 kg/m2, inclusive.

Exclusion Criteria:

* Subjects with a decrease in SBP of \>=20 mm Hg and increase in HR of \>=20 bpm after 2 minutes standing vs. 2 minutes supine at screening or with frank orthostatic hypotension at screening.
* Supine BP of 90/50 mm Hg or lower at screening
* SBP \>=140 mm Hg or DBP \>=90 mm Hg at screening

Primary outcomes:
measure: Multiple dose PK parameters for venlafaxine+metabolite when administered alone and with aripiprazole will be derived. Cmin for aripiprazole,dehydro-aripiprazole will be measured
Secondary outcomes:
measure: Safety will be based on review of AEs, VS, ECGs, physical exam, clinical labs
Other outcomes:
Locations:
city: Miami
country: United States
facility: Local Institution
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Boulton DW, Balch AH, Royzman K, Patel CG, Berman RM, Mallikaarjun S, Reeves RA. The pharmacokinetics of standard antidepressants with aripiprazole as adjunctive therapy: studies in healthy subjects and in patients with major depressive disorder. J Psychopharmacol. 2010 Apr;24(4):537-46. doi: 10.1177/0269881108096522. Epub 2008 Oct 2.
Clinical trial NCT01460771: Transcranial Direct-Current Stimulation in Childhood Dystonia
Official title: Pilot Open-label and Blinded Clinical Trial of Transcranial Direct-current Stimulation in Childhood Dystonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Childhood Onset Dystonias
Keywords: childhood dystonia
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Crowley Carter Foundation
name: Don and Linda Carter Foundation
First posted: 2011-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that transcranial direct current stimulation over the motor cortex will reduce muscle overflow and improve hand function in children with primary or secondary dystonia.


Eligibility criteria: Inclusion Criteria:

* dystonia affecting one or both hands
* age 4 to 21 years

Exclusion Criteria:

* metal implants in the head
* inability to cooperate with instructions

Primary outcomes:
measure: Hand muscle overflow
timeFrame: 10 minutes post- transcranial Direct-current Stimulation (TDCS)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Terence Sanger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01443871: Effect of Essential Oils in Aromatherapy on Emotional Relaxation
Official title: Effect of Essential Oils in Aromatherapy on Emotional Relaxation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Volunteer
Lead sponsor: University of Phayao
Sponsor class: OTHER
First posted: 2011-09-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to examine and compare electroencephalography (EEG) changes in human subjects directly after inhalation of essential oils from five Thai aromatherapies. The investigators hypothesize that essential oils from Thai aromatherapies may influence the human EEG involving emotional relaxation particularly alpha wave EEG.

Detailed description: The subjects consisted of 22 male and 26 female subjects , ages between 20 to 30 years (mean age, 23.3 years). They were screened for excessive nasal congestion, drug and food taken, and neurological disorders prior to participation in the experiment. The experiments were approved by the Ethical Committee for Research Involving Human Research Subject, Naresuan University. All subjects read and signed an informed consent before participation.

Eligibility criteria: Inclusion Criteria:

* \> 18 years old

Exclusion Criteria:

* excessive nasal congestion
* neurological disorders prior to participation in the experiment

Primary outcomes:
measure: electroencephalography (EEG) changes
timeFrame: baseline, 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Surasak Saokaew
state: Phayao
city: Muang
country: Thailand
facility: University of Phayao
state: Phayao
Study officials:
affiliation: University of Phayao
name: Surasak Saokaew, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06741371: Difference Between Monofilament Versus Multifilament Suture Material in Isthmocele Formation
Official title: Impact of Using Synthetic Absorbable Monofilament Versus Multifilament Suture Material for Uterine Closure on the Development of Uterine Isthmocele : A Rondamized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uterine Scar
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This thesis conducts the effect of using different suture materials on the development of uterine scar niche after cesarean section.

The difference between monofilament and multifilament sutures and the special properties of each one .

The primary outcome of the study is to know which material conducts more scar niche formation .

Secondary outcomes are the extent of blood loss , the need of extra hemostatic sutures


Eligibility criteria: Inclusion Criteria:

* Age: 20-45 years old

  * Singleton pregnancy.
  * Gestational age between 37 completed weeks to 42 weeks.
  * Patients undergoing elective primary caesarean section

Exclusion Criteria:

* History of uterine surgery (e.g. hysterotomy, myomectomy, perforation, caesarean section). (to be able to differentiate between the recent CS scar and the old scar)

  * Abnormal placental invasion (placenta previa and accrete ) ( more liable to undergo Cesarean hysterectomy)
  * Uterine anomalies (e.g., septum, Mullerian anomalies or fibroids). (may be localized at the suture line and therefore affect the scar)
  * Drugs intake that affects bleeding or tissue healing e.g., anti-coagulants, immunosuppressive drugs and chronic use of steroids (more than 14 days pre-operative)
  * Any medical Co-morbidity (diabetes mellitus, Hypertension and Thyroid abnormalities) (more liable to affect the healing)

Primary outcomes:
measure: The incidence of isthmocele by transvaginal ultrasound 6 months after delivery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine
state: Abbasya
Study officials:
References:
Clinical trial NCT02503371: The Effect of In Vitro Fertilization on Coagulation Parameters as Measured by Thromboelastogram
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertilization in Vitro and Blood Coagulation Factors
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2015-07-21
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturients undergoing in-vitro fertilization treatment

Brief summary: Since its introduction in 1978, over 3.75 million babies have been born using in vitro fertilization (IVF). Maturing ovarian follicles lead to a large rise in estrogen to supra-physiological levels . This increase in estrogen has been shown to cause a hypercoagulable state, leading at times to arterial and venous thrombosis.(Thromboelastogram (TEG) is a point of care whole blood hemostatsis analyzer mimicking in vivo conditions and measuring visco elastic properties of the clot. The TEG shows effect of most of the components of hemostatsis: coagulation factors, fibrinogen, platelets and fibrinolysis. Components of TEG include R, reflecting coagulation factor cascade, alpha angle and K measurements reflecting fibrin function, MA reflecting mostly thrombocyte function, coagulation index (CI) measuring global hemostatic statis and LY30 measuring fibrinolysis.

In this study the investigators would like to measure serum estrogen levels and (TEG) in parturients at the beginning and conclusion of an IVF simulation cycle and evaluate how it's influnence on coagulation parameters, and wheather or not a large sample size will effect primary outcomes.

Secondarily the investigators would like to see if estrogen levels are predictors of coagulation parameters and see if age influences TEG parameters


Eligibility criteria: Inclusion Criteria:

* Parturients above 18 undergoing in-vitro fertilization at rabin medical center, with the ability to comply with the study requriments.

Exclusion Criteria:

Parturients were excluded if they had;

* hypertension,
* diabetes,
* anticoagulation therapy or any platelet disorder,
* or were not able to comply with study requirments.

Primary outcomes:
measure: Measurement of fibrin function in parturients undergoing IVF by Thromboelastogram
timeFrame: one year
measure: Measurement of thrombocyte function in parturients undergoing IVF by Thromboelastogram
timeFrame: one year
measure: Measurement of global hemostatic statis in parturients undergoing IVF by Thromboelastogram
timeFrame: one year
measure: Measurement of fibrinolysisin parturients undergoing IVF by Thromboelastogram
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Petach tikvah
country: Israel
facility: Beilinson hospital
Study officials:
References:
Clinical trial NCT01053871: Propofol Versus Midazolam With Fentanyl for EGD Endomicroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastritis
Functional Dyspepsia
Keywords: normal
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2010-01-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This trial aims to compare the endomicroscopic image quality and sedation efficacy of propofol or midazolam with fentanyl.


Eligibility criteria: Inclusion Criteria:

* outpatients attending endomicroscopy
* able to give written informed consent

Exclusion Criteria:

* GI tract malignancy
* coagulopathy
* acute upper digestive tract bleeding
* pregnancy or breast feeding
* allergy to fluorescein sodium
* impaired renal function

Primary outcomes:
measure: endomicroscopic image quality
timeFrame: 3 months
Secondary outcomes:
measure: sedation efficacy outcomes,patient assessment,physician assessment
timeFrame: 3 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology, Qilu Hospital, Shandong University
name: Yanqing Li, PhD. MD.
role: STUDY_DIRECTOR
References: