louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01964963: Alogliptin Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus
Official title: Alogliptin (Nesina) Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-10-17
Enrollment: 19192
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 mild type 2 diabetes mellitus who have been examined at a medical institution

Brief summary: The purpose of this study is to examine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical setting.

Detailed description: This is a special drug use surveillance on long-term use of alogliptin, designed to investigate the safety and efficacy of treatment with alogliptin in patients with mild type 2 diabetes mellitus in the routine clinical setting.

Participants will be patients with mild type 2 diabetes mellitus. The planned sample size is 20,000.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg of alogliptin) once daily.

Eligibility criteria: Inclusion Criteria:

-Patients with Haemoglobin A1c (HbA1c) \[Japan Diabetes Society (JDS) value\] ≤7.0% at the time of enrolment (within 3 months before initiation of alogliptin therapy), regardless of the use of antidiabetic medication.

Exclusion Criteria:

-Patients contraindicated for alogliptin.

1. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus.
2. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury.
3. Patients with a history of hypersensitivity to any ingredient of alogliptin.

Primary outcomes:
measure: Percentage of Participants Who Had One or More Adverse Events
timeFrame: Up to Month 36
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, and final assessment point (up to Month 36)
Secondary outcomes:
measure: Change From Baseline in Fasting Blood Glucose
timeFrame: Baseline, and final assessment point (up to Month 36)
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00945763: Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery
Official title: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Adaptive Design, Single-Dose Study of Intravenous N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Pain
Keywords: Dental Pain
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-24
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction surgery.

Detailed description: This is a randomized, double-blind, placebo-controlled, single center study in subjects who have undergone third molar extraction surgery. Eligible subjects will have surgical removal of \>2 third molars, of which at least 1 must be a complete or partial mandibular impaction. Each subject's study participation will consist of a screening visit (1-21 days prior to surgery), an inpatient evaluation period of 24 hours following dosing, and a follow-up phone call 3-5 days postdose.

Eligibility criteria: Inclusion Criteria:

* surgical extraction of \> 2 third molars with at least 1 complete or partial mandibular bony extraction

Exclusion Criteria:

* allergic response to aspirin, NSAIDs, acetaminophen or hydrocodone
* use of aspirin or other analgesics within 48 hours prior to surgery
* current or recent history of drug or alcohol abuse
* any medication for treatment of chronic pain
* clinically significant abnormality on screening laboratory test active or recent history of peptic ulcer disease or GI bleeding
* prior abdominal surgery, except uncomplicated appendectomy
* any other surgical procedure within 30 days before administration of study drug
* pregnancy or breastfeeding
* untreated hypertension; SBP \> 140 mmHg or DBP \> 95 mmHg

Primary outcomes:
measure: Pain Intensity Difference at End of Study
timeFrame: 0-24 hours
Secondary outcomes:
measure: Onset of action
timeFrame: 0-1 hour
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Jean Brown Research, Salt Lake City, UT 84124
name: Steven Christensen, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Viscusi ER, Gan TJ, Bergese S, Singla N, Mack RJ, McCallum SW, Du W, Hobson S. Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects. Reg Anesth Pain Med. 2019 Mar;44(3):360-368. doi: 10.1136/rapm-2018-100184. Epub 2019 Feb 7.
citation: Christensen SE, Cooper SA, Mack RJ, McCallum SW, Du W, Freyer A. A Randomized Double-Blind Controlled Trial of Intravenous Meloxicam in the Treatment of Pain Following Dental Impaction Surgery. J Clin Pharmacol. 2018 May;58(5):593-605. doi: 10.1002/jcph.1058. Epub 2018 Jan 12.
Clinical trial NCT02232763: Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria
Official title: A Prospective, Randomized, Cross-over Study Evaluating the Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Proteinuria
Keywords: Losartan
children
proteinuria
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Food and Drug Safety, Korea
First posted: 2014-09-05
Enrollment: 58
Sex: ALL
Minimum age (years): 24
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that using Losartan would help decrease proteinuria in pediatric chronic kidney disease with tubular proteinuria.

Detailed description: Children with tubular proteinuria (urine protein to creatinine ratio \> 0.3 mg/mg) were randomly assigned in 1:1 ratio to losartan or placebo treatment for 12 weeks, then crossed over to the opposite intervention for another three months after a washout period of 2 weeks. The primary outcome is the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks. Efficacy of losartan in children with CKD with tubular proteinuria was also investigated with additional retrospective review of medical record.

Eligibility criteria: Inclusion Criteria:

* Age: 2years or older and younger than 18 years
* estimated GFR ≥ 30mL/min/m\^2
* Mean urinary protein-creatinine ratio \> 0.3 g/g from three first-morning spot urine collections
* Renal hypoplasia/dysplasia, Reflux nephropathy, Polycystic kidney disease, Lowe syndrome, Dent disease, Tubulointerstitial nephritis, Nephronophthisis/Medullary cystic disease, Obstructive uropathy(including PUV, UPJ obstruction, UVJ obstruction)

Exclusion Criteria:

* hypertension
* under dialysis or organ transplanted
* bilateral renal artery stenosis or primary hyperaldosteronism
* pregnant or nursing

Primary outcomes:
measure: the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: the change in urinary albumin-creatinine ratio from baseline to the end of study
timeFrame: 12 weeks
measure: the proportion of patients wifh more than 50% decrease of urinary protein-creatinine ratio
timeFrame: 12 weeks
measure: the change in urinary beta2-microglobulin-creatinine ratio from baseline to the end of study
timeFrame: 12 weeks
measure: the change in urinary NAG-creatinine ratio from baseline to the end of study
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
affiliation: Seoul National University Children's Hospital Departments of Pediatrics
name: Hee Gyung Kang, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT06235463: Pedal Pump and Leg Lymphedema
Official title: Effectiveness of the Osteopathic Pedal Pump in Reducing Lower Limb Volume in Older Adults with Chronic Leg Lymphedema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphedema
Lead sponsor: Rowan University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 72
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Fifty two participants will be randomized to one of two conditions: to receive the osteopathic pedal pump (treatment group) or to receive a light tough treatment (control group).
Primary purpose: TREATMENT

Brief summary: Chronic lymphedema in the lower extremities is a common problem found in older adults that can result in cellulitis, poor wound healing, venous stasis ulcers, and other comorbidities. Compressive therapies are the present gold standard for the manual treatment of lymphedema in the lower extremities. However, the benefits of these compressive therapies are modest, and they are not well tolerated by older adults. An alternative manual treatment is the osteopathic pedal pump, an osteopathic manipulative treatment, that uses a rhythmical pumping motion instead of compressive force to move interstitial fluid from the lower extremities back to the circulatory system. However, the evidence that the osteopathic pedal pump can reduce volume in the lower extremities remains anecdotal. The aim of this study is to determine if the osteopathic pedal pump can reduce volume in the lower extremities among older adults with chronic lymphedema. Leg volume will be measured using water displacement. Older adults with chronic lymphedema of the lower extremities will be randomly assigned to one of two groups: a treatment group that will receive one session of the osteopathic pedal pump and a control group that will receive one session of a light touch treatment.


Eligibility criteria: Inclusion Criteria:

* Age 55 years old or older
* Have lower leg lymphedema

Exclusion Criteria:

* Any type of acute medical issue or exacerbation
* A chronic medical condition (e.g., asthma, chronic obstructive pulmonary disease, congestive heart failure)
* An active tissue infection or an open wound in the lower limb
* An active bone fracture
* Acute deep venous thrombosis not fully anticoagulated
* Dementia

Primary outcomes:
measure: Change in limb volume
timeFrame: The time frame in which the pre and post-treatment measurements will take place in one session that will take approximately 30-45 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Stratford
country: United States
facility: Rowan University School of Osteopathic Medicine
state: New Jersey
Study officials:
References:
Clinical trial NCT03849963: Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain
Official title: Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Brain Metabolism
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: Investigators propose to develop hyperpolarized \[13C\]-labeled pyruvate as potential imaging probes to assess two essential in vivo processes in cerebral metabolism: oxidative metabolism and synthesis of a neurotransmitter in this observational study.

Detailed description: Investigators will perform a pilot study to test the translational feasibility by evaluating sensitivity and repeatability of hyperpolarized \[1-13C\]pyruvate and \[2-13C\]pyruvate in healthy human subjects (n =10 each). Each subject will be imaged twice using the same hyperpolarized substrate with an interval (\<45min) between the injections to evaluate repeatability. Finally, eight subjects will be imaged with both hyperpolarized \[1-13C\]pyruvate and \[2-13C\]pyruvate for comparison.

Eligibility criteria: Inclusion Criteria:

* 18 through 60 years of age.
* Healthy, with no neurological abnormalities.
* Ability to understand and the willingness to sign a written informed consent.
* All races and ethnicities will be included; subjects must be able to read and speak the English language.

Exclusion Criteria:

* Metallic foreign bodies on the scalp or cranium which may interfere with MRI acquisitions
* Major debilitating neurological disease including, but not limited to, stroke, CVA, dementia and tumor that would limit compliance with study requirements
* Under influence of illicit drugs which are known to alter brain physiology/metabolism including, but not limited to cocaine, lysergic acid diethylamide (LSD), and marijuana at the time of MRI/MRSI scanning.
* Under influence of antiepileptic drugs at the time of MRI/MRSI scanning.
* Any contraindication per MRI Screening Form including
* Implants contraindicated at 3T, pacemakers
* Implantable Cardioverter Defibrillator (ICD)
* Claustrophobia
* Medically unstable including
* Heart failure
* Severe left ventricular outflow tract (LVOT) obstruction
* Unstable angina
* Pregnancy
* Lactating

Primary outcomes:
measure: Development of 13C ratio maps in the brain of healthy participants
timeFrame: Measurements made during study scan
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern - Advanced Imaging Research Center
state: Texas
Study officials:
References:
Clinical trial NCT04607863: Foot Posture Index, Hallux Limitus in Patients With Chronic Low Back Pain. Gait With Optogait Sensor
Official title: Foot Posture Index Pronated, Hallux Limitus Connection and Chronic Low Back Pain Gait Parametrers With Optogait Sensor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hallux Limitus
Movement, Abnormal
Back Pain Lower Back Chronic
Keywords: foot
hallux
limitus
back
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Males and females between 18 and 65 years old

Brief summary: Foot disorders have been recognized as being linked to chronic low back pain

Detailed description: Foot disorders have been recognized as being linked to chronic low back pain (CLBP), To improve knowledge of the relationship between the limitation of the movement range of hallux (HROML) is important about it can affect the back biomechanical . The aim of this research is to investigate if the HROML may appear as a risk factor of CLBP

HROML affect the foot position, and consecuently may induce to alter as compensatory mechanism the normal biomechanical of the leg, hip and back.

Eligibility criteria: Inclusion Criteria: males and females between 18 to 65 years old Hallux limitus in one or two feet -

Exclusion Criteria:

serious illness, current participation in another research study pregnancy previus foot or back surgery

-

Primary outcomes:
measure: Hallux dorsal movement range degrees
timeFrame: A day, the inclusion day in the study
Secondary outcomes:
measure: Low back pain
timeFrame: a day, the inclusion day in the study
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Aurora Castro Mendez
Study officials:
References:
Clinical trial NCT02174835: A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers
Official title: A Phase 1, Single-center, Randomized, Open-label Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide/Quinidine Sulfate) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Healthy Volunteers
deuterated dextromethorphan
deuterated dextromethorphan with quinidine
Lead sponsor: Avanir Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-06-26
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated \[d6\] dextromethorphan hydrobromide \[DM\]/quinidine sulfate \[Q\]) in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males
* 18 - 45 years of age
* BMI 18 - 30 kg/m2

Exclusion Criteria:

* History or presence of significant disease
* History of substance abuse and/or alcohol abuse with the past 3 years
* Use of tobacco-containing or nicotine-containing products within 6 months
* Use of any prescription or the over-the-counter medications within 14 days

Primary outcomes:
measure: Plasma concentrations of AVP-786
timeFrame: 7 days
Secondary outcomes:
measure: Incidence of adverse events (AEs) for AVP-786
timeFrame: 7 days
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX
state: South Australia
Study officials:
affiliation: CMAX
name: Sepehr Shakib, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00441935: InterStim Prospective Database
Official title: InterStim Prospective Database for Outcomes Research
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Urinary Retention
Urinary Incontinence
Pelvic Pain
Keywords: Urinary Retention
Urinary Incontinence
Pelvic Pain
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: William Beaumont Hospitals
First posted: 2007-03-01
Enrollment: 736
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients at least 18 years of age scheduled for sacral nerve stimulator implantation at William Beaumont Hospital, Royal Oak

Brief summary: The study is to collect information from patient charts and patient questionnaires to evaluate the effects of nerve stimulation therapy on urinary dysfunction.

Detailed description: Men and women with urinary incontinence (leakage of urine), frequency, and bladder pain experience embarrassment, inconvenience, and a significant negative impact on their quality of life. Although traditional treatments such as medications, diet modification, and bladder training provide relief for some people, others do not experience improvement with these treatments. Recently, mechanical devices much like a heart pacemaker have been developed to stimulate the nerves (sacral and pudendal) responsible for controlling bladder function. During a two stage operation, a permanent electrical wire is implanted in the lower back and connected to a mechanical box (stimulator) implanted under the patients skin in the hip area.

Participants will be asked to complete a set of questionnaires (Intake Form, Urinary Incontinence Treatment Network (UITN) Sexual Activity Questionnaire, Interstitial Cystitis Symptom Index and Problem Index, voiding diary) within 60 days prior to the procedure. Preoperative clinical information such as primary diagnosis, history of failed therapies, and medical history will be collected from the physician office record, and operative information will be collected from the inpatient hospital record. After the two stage operation (3, 6, and 12 months, then yearly thereafter as long as the device is in place) participants will be sent questionnaires. Upon completion and return to the study site

Eligibility criteria: Inclusion Criteria:

* All patients at least 18 years of age scheduled for sacral nerve stimulator implantation at William Beaumont Hospital, Royal Oak, Michigan who give informed consent to participate in the project.

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Kenneth Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05374135: Effect of Dexamethasone on Fetal Heart Rate Variables In Case Of Imminent Preterm Labor
Official title: Effect of Dexamethasone on Fetal Heart Rate Variables In Case Of Imminent Preterm Labor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Heart Rate or Rhythm Abnormality Affecting Fetus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 97
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: Effect of dexamethasone on fetal heart rate variability in case of preterm labour: prospective cohort study

Detailed description: prospective cohort study on Effect of dexamethasone on fetal heart rate variability in case of preterm labour

Eligibility criteria: Inclusion Criteria:

* Preterm labor

Exclusion Criteria:

* Twins

Primary outcomes:
measure: Changes in fetal heart rate variability in relation to dexamethasone administration
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assiut University
name: Tarek Kh Al-Hussini
role: PRINCIPAL_INVESTIGATOR
References: