louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00687232: Safety, Tolerability and Pharmacokinetics of Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers
Official title: A Randomised, Placebo-controlled Single-blind, Single-centre Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I
Japan
Japanese
inhalation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to investigate safety and tolerability of single and multiple ascending inhaled doses of AZD4818 in healthy Japanese male volunteers.


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent
* Body Mass Index (BMI) between 18.0-27.0 kg/m2
* No clinically relevant abnormal findings

Exclusion Criteria:

* Acute illness which requires medical intervention
* Definite or suspected personal history of adverse drug reactions or drug hypersensitivity.
* Clinical relevant disease or disorder (past or present)
* A history of respiratory disorders

Primary outcomes:
measure: Incidence and nature of adverse Event, 12-lead ECG, BP, pulse rate, body temperature, spirometry
timeFrame: During the study
measure: Lab assessment
timeFrame: During the study
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: During the study
Other outcomes:
Locations:
city: Osaka-city
country: Japan
facility: Research Site
state: Osaka
Study officials:
affiliation: Osaka Pharmacology Clinical Research Hospital
name: Michio Yagi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00919932: Using a Text-message System to Engage Depressed Adolescents in Cognitive-behavioral Therapy Homework
Official title: Using a Text-message System to Engage Depressed Adolescents in Cognitive-behavioral Therapy Homework.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Cognitive Behavior Therapy
Text Messaging
Keywords: Depression
CBT
Texting
SMS
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: American Academy of Child Adolescent Psychiatry.
First posted: 2009-06-12
Enrollment: 9
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of the pilot is to test the feasibility and utility of using a text-messaging system to engage adolescents in improved homework adherence during cognitive-behavioral therapy (CBT) for major depressive disorder.

Detailed description: Adolescent major depressive disorder leads to recurrent episodes, increased rates of attempted and completed suicides, and persistent social impairment between episodes (Weissman et al 1999). Cognitive behavioral therapy (CBT) is an accepted first-line therapy for mild-moderate depression in adolescents. Integral to CBT is "homework" as it enhances mastery of newly learned coping strategies, facilitates generalization of skills to novel situations, increases self-efficacy, and ultimately reduces vulnerability to relapse (Detweiler et al 1999). Adherence to homework is a recognized problem in adults, and is similarly problematic in adolescents. One method of implementing CBT homework in a manner that is centric to current youth culture is through text messaging. By using a modern modality that many adolescents rely on for daily communication, there is the likelihood that they will find it more engaging than traditional modalities. Thus the potential that a text message system can help improve homework compliance in adolescents is significant, because improved homework adherence may ultimately be linked to improved clinical outcomes for these disorders with high rates of chronic morbidity and mortality.

Eligibility criteria: Inclusion Criteria:

* major depressive disorder
* own a cellular phone with text messaging capabilities

Exclusion Criteria:

* history of psychosis
* history of mental retardation
* active suicidal ideation or intent

Primary outcomes:
measure: Therapy Homework Compliance: Percent Homework Completed
timeFrame: 1 month
Secondary outcomes:
measure: Exit Interview
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Han-chun Liang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01159132: Pharmacokinetics of Low Dose Raltegravir
Official title: Pharmacokinetics of Low Dose Raltegravir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: pharmacokinetics
low dose raltegravir
HIV
To study the pharmacokinetics profile of low dose raltegravir (RAL) (400mg OD and 800mg OD) and standard dose of 400mg BID in Thai HIV-infected patients.
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: National Healthcare Group Pte Ltd, Singapore
name: Chulalongkorn University
First posted: 2010-07-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to study and compare the pharmacokinetics profile of low dose raltegravir (RAL) (400mg OD and 800mg OD) and standard dose of 400mg BID in Thai HIV-infected patients.

Detailed description: Twenty four HIV-infected volunteers on stable doses of RAL 400 mg BID for at least 3 months and with undetectable viral load will be enrolled. On Day 1, all 24 subjects will attend the first intensive PK collection for RAL 400 mg BID and the blood samples will be drawn at T = 0.0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, and 12.0 hour post medication. All 24 subjects will be randomised (1:1) to either Group A (RAL 400 mg OD) or Group B (RAL 800 mg OD) for 14 days. On day 15, a second 24 hour intensive PK will be carried out and the blood samples will be drawn. After 2nd intensive PK, the subjects will switch to the other dosing regimen. Subjects in group A will receive RAL 800 mg OD and group B will receive RAL 400 mg OD for another 14 days. On day 29, the third 24 hour intensive PK will be carried out. After the 3rd intensive PK, all 24 subjects will be switched back to the initial regimen of RAL 400 mg BID.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Evidence of HIV infection
* Age\> 18 years
* On RAL 400 mg BID containing HAART regimen with a VL \< 50 copies for at least 3 months before enrollment
* Willing to adhere to the protocol requirements

Exclusion Criteria:

* Evidence of RAL resistance
* History of RAL allergy
* Use of concomitant medication that may interfere with the pharmacokinetics of RAL
* Current pregnancy or lactating or planning to get pregnant
* Active drug abuse or alcoholic
* Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.

Primary outcomes:
measure: pharmacokinetics of RAL in Thais
timeFrame: 29 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: HIV-NAT
Study officials:
affiliation: The HIV Netherlands Australia Thailand Research Collaboration
name: Jintanat Ananworanich, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06494332: Prevention of Lateral Epicondylalgia in Handgun Olympic Shooting Athletes
Official title: Effect of Exercise Combined With Stretching Program to Prevent Lateral Epicondylalgia in Handgun Olympic Shooting Athletes: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epicondylitis, Lateral
Keywords: Prevention
Epicaondylalgia
Exercise
Stretching
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 61
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Lateral epicondylalgia is one of the most common pathologies suffered by Olympic gun shooting athletes. In Spain, there is hardly any research carried out in this sport, so there are no injury prevention protocols available. Preventing these injuries would be fundamental to improve the performance of athletes and to be able to continue adding successes to national honors.

It has also been evidenced that if exercise is combined with stretching, the benefits of physical therapy are increased. High-quality studies have stated that it is not necessary for this exercise protocol combined with stretching to be very prolonged over time, as they affirm that significant improvements can be achieved with only four weeks of exercise.

This study aimed to test the hypothesis that Olympic handgun shooting athletes who perform a four-week multimodal exercise program combined with stretching have a lower risk of suffering from lateral epicondylalgia than athletes who do not perform this program, determining its effectiveness for pain prevention.


Eligibility criteria: Inclusion Criteria:

* Adults aged \>35 years
* Present a risk of suffering from lateral epicondylalgia
* Be in possession of a federation Olympic shooting license
* Practice Olympic shooting with handgun and carry out at least one Olympic shooting training session a week or have participated in the last three months in an official competition

Exclusion Criteria:

* Subjects who had serious uncontrolled illnesses
* Who had undergone surgery as a treatment for lateral epicondylalgia
* Who had received treatment for lateral epicondylalgia in the last month or injections of corticosteroids or steroids for this pathology in the last 6 months
* Who had suffered a serious upper limb injury in the last year or present a risk of suffering epicondylalgia due to a cause other than Olympic shooting

Primary outcomes:
measure: Pain - Algometer
timeFrame: 0 week, 4 week
measure: Pain - Visual Analogic Scale
timeFrame: 0 week, 4 week
Secondary outcomes:
measure: Hand grip strength
timeFrame: 0 week, 4 week
measure: Range of movement
timeFrame: 0 week, 4 week
measure: Subjective perception
timeFrame: 0 week, 4 week
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: David Hernández Guillén
Study officials:
affiliation: University of Valencia
name: David Hernández-Guillén, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05368532: Excitability Protocol: Voltage-gated Ion Channels
Official title: Novel Excitability Protocol to Identify Alteration of Voltage-gated Ion Channels
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of subproject 1 is to evaluate the accuracy of a nerve excitability protocol in healthy subjects before testing the protocol in diabetic neuropathy patients. The nerve excitability protocol has been derived by computational modeling to identify abnormalities of three subtypes of ion voltage-gated channels. These three ion channels are all altered in animal models of diabetic neuropathy and, therefore, are likely candidates for generating the altered excitability in diabetic neuropathy patients. The hypothesis for subproject 1 is that due to the unique dynamics of each subtype of voltage-gated ion channels, it is possible to identify abnormal voltage-gated ion channel alterations by altering the shape of the electrical stimulation.


Eligibility criteria: Inclusion Criteria: Healthy men and women in the age 18-80 years who speak and understand English.

Exclusion Criteria:

* Pregnancy or breast feeding
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous and present neurologic, musculoskeletal or mental illnesses (e.g., epilepsy, neuropathy, fibromyalgia and depression)
* Skin diseases
* Past history of conditions possibly leading to neuropathy
* Inability to cooperate
* Current use of medications that may affect the study, e.g., analgesics
* Previous traumatic experience of an electrical accident
* Consumption of alcohol or painkillers within the last 24 hours
* Participation in other pain studies throughout the study period
* Patients with cardiac diseases (e.g., pacemaker).

Primary outcomes:
measure: Perception threshold for the excitability
timeFrame: Approximately 5 minutes to estimate.
Secondary outcomes:
measure: Sensation
timeFrame: Approximately 5 minutes to estimate.
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
Study officials:
affiliation: Aalborg University
name: Jenny Tigerholm
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05078632: Montreal Toulouse Test With Eye Tracking in Intensive Care Unit to Evaluate Comprehension
Official title: Montreal Toulouse 86 Test Modified to be Used With Eye Tracking: Test Automation and Eye Course in Healthy Volunteers and Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Care
Keywords: eye tracking
critical care
comprehension
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and patient hospitalized in intensive care unit

Brief summary: Assessment of the level of oral comprehension of the intensive care patient is essential to improve their care because they have often troubles like delirium.

Detailed description: Assessment of the level of oral comprehension of the intensive care patient is essential to improve their care because they have often troubles like delirium.

Eligibility criteria: Inclusion Criteria:

* French speaker, RASS (Richmond Agitation-sedation scale) between -1 and +1, agree for participation

Exclusion Criteria:

* neurovisual disorders

Primary outcomes:
measure: Establish eye tracking standards for the test
timeFrame: during hospitalization in intensive care
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: University Hospital of TOURS
name: Laetitia BODET-CONTENTIN, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03748732: Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes
Official title: Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nanophthalmos
Keywords: uveal effusion
Lead sponsor: Rafic Hariri University Hospital
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: surgery
Primary purpose: TREATMENT

Brief summary: Purpose: To describe an extensive scleral excision technique to treat or prevent uveal effusion in nanophthalmic eyes.

Design: Prospective interventional case series.

Methods:

* Setting: Institutional.
* Patient Population: Consecutive patients with nanophthalmos were operated on by one surgeon.
* Intervention Procedure: A single, 90% thickness scleral window extending from immediately behind the extraocular muscle insertions to the vortex veins was performed for 3 and 1/4 quadrants as a circumferential strip.
* Main Outcome Measure: Resolution or prevention of uveal effusion.

Detailed description: Surgical Technique All surgeries were performed under general anesthesia by one surgeon (AMM). Because the majority of the patients were young with narrow palpebral fissures and very deep set globes in small orbits, special surgical techniques were required. Lateral canthotomy was performed on all patients except for the first. Limbal 360o conjunctival peritomy was followed by securing of each rectus muscles with a modified muscle hook and 2-0 silk suture. Scleral dissection was performed from immediately behind to the muscle insertions posterior to the vortex veins. A 90% depth scleral window was excised over 3 and ¼ quadrants, excluding 3/4 of the superior temporal quadrant to avoid damaging the superior oblique muscle.

Eligibility criteria: Inclusion Criteria: nanophthalmos -

Exclusion Criteria: None

-

Primary outcomes:
measure: resolution of uveal effusion
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Rafic Hariri University Hospital
state: South Beirut
Study officials:
affiliation: Rafic Hariri University Hospital
name: Ahmad Mansour, MD
role: STUDY_CHAIR
References:
citation: Carricondo PC, Andrade T, Prasov L, Ayres BM, Moroi SE. Nanophthalmos: A Review of the Clinical Spectrum and Genetics. J Ophthalmol. 2018 May 9;2018:2735465. doi: 10.1155/2018/2735465. eCollection 2018.
citation: Mansour A, Stewart MW, Shields CL, Hamam R, Abdul Fattah M, Sheheitli H, Mehanna CJ, Yassine S, Chahine H, Keaik M, Maalouf F, Jaroudi M. Extensive circumferential partial-thickness sclerectomy in eyes with extreme nanophthalmos and spontaneous uveal effusion. Br J Ophthalmol. 2019 Dec;103(12):1862-1867. doi: 10.1136/bjophthalmol-2018-313702. Epub 2019 Mar 15.
Clinical trial NCT05121532: Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients With Non-segmental Vitiligo
Official title: Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients With Non-segmental Vitiligo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitiligo
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients with Non-segmental Vitiligo before and after phototherapy

Detailed description: This prospective study will include 30 patients with NSV, attending the Outpatient Clinics of Dermatology at Sohag University Hospitals, as well as 30 normal volunteers as control.

This study will be submitted for approval by Research and Ethical committees at Sohag Faculty of Medicine. An informed written consent will be obtained from each subject prior to participation in the study after full explanation of the procedure.

Eligibility criteria: Inclusion Criteria:

* • Patients suffering from non segmental vitiligo.

  * Patients not on medical treatment or phototherapy for vitiligo in the last 3 months.

Exclusion Criteria:

* • Patients with systemic or cutaneous inflammatory disorders.

  * Patients on treatment for vitiligo in last 3 months.
  * Pregnant and lactating patients.
  * Patients with history of diabetes.
  * Patients with history of autoimmune diseases.

Primary outcomes:
measure: Evaluation of Serum Interleukin-15 and Interleukin-22 Levels
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03694132: Brain Excitability and Connectivity in Sensory-motor Pathways in ALS
Official title: Evaluation and Characterization of Infraclinical Sensory Deficits in Amyotrophic Lateral Sclerosis by Brain Imaging and Electrophysiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Brain excitability
Brain connectivity
Motor cortex
Somatosensory cortex
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2018-10-03
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients vs. health subjects
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective is to determine the origin of somatosensory alteration in patients with ALS and to evaluate its impact on brain activity by coupling different imaging modalities and indirect electrophysiology.

The secondary objective is to evaluate whether the observed functional changes in MEG / EEG and functional MRI correlate with structural lesions revealed with diffusion MRI (anatomo-functional connectivity of the brain).

Detailed description: Somatosensory evoked potentials (SEPs) produced by ulnar nerve electrical stimulation will be collected with combined MEG and EGG.

Functional MRI will be performed during electrical stimulation of ulnar nerve and during mechanical vibration of ADM tendon.

Brain diffusion MRI will be performed. Anatomical MRI will be done for source location. Brain resting state activity will be recorded with MEG/EEG and fMRI.

Eligibility criteria: Inclusion Criteria:

* ALS, MRC score ≥ 4 at least in one hand
* Controls: no history of neurological disorders, right-handed

Exclusion Criteria:

* contraindication to MRI

Primary outcomes:
measure: Brain activity
timeFrame: 1 hour
Secondary outcomes:
measure: Brain connectivity
timeFrame: 15 min
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Pitie-Salpetriere
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pierre-Francois Pradat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Veronique Marchand-Pauvert, PhD
role: STUDY_DIRECTOR
References:
citation: Sangari S, Giron A, Marrelec G, Pradat PF, Marchand-Pauvert V. Abnormal cortical brain integration of somatosensory afferents in ALS. Clin Neurophysiol. 2018 Apr;129(4):874-884. doi: 10.1016/j.clinph.2017.12.008. Epub 2017 Dec 24.
Clinical trial NCT04674332: Long Acting Insulin Versus Multiple Dose Regimen for Control of Gestational Diabetes Mellitus
Official title: Comparative Study Between Use of Long Acting Insulin Versus Multiple Dose Regimen in Control of Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Long Acting Insulin in Control of Gestational Diabetes Mellitus
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 148
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: multiple dose regimen as a standard treatment for gestational diabetes will be compared to long acting insulin


Eligibility criteria: Inclusion Criteria:

* pregnant women with gestational diabetes mellitus
* between 24-28 weeks gestation

Exclusion Criteria:

* other endocrinological abnormalities

Primary outcomes:
measure: time needed to achieve glycemic control
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
References: