louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04354987: Compare the Pharmacokinetics and Safety of CKD-391
Official title: Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D090 and D337 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperlipidemias
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2020-04-21
Enrollment: 44
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: phase I clinical trial to compare the pharmacokinetics and safety of CKD-391 with co-administration of D090 and D337 in healthy adult volunteers


Eligibility criteria: Inclusion Criteria:

1. Between 19 aged and 45 aged in healthy male adult
2. Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations.
3. Not abnormal or not clinically significant lab values.
4. Subjects who signed informed consent form with good understandings after explanations by investigators.

Exclusion Criteria:

1. No history or presence of clinically significant diseases.
2. Subjects showing adverse reaction to investigational product
3. Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
4. History of myopathy
5. unable to stop drinking and smoking during clinical trials
6. Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
7. History of drug abuse
8. Disagree to contraception
9. Subjects who are in any conditions impossible participating in the clinical trials

Primary outcomes:
measure: Cmax
timeFrame: 0~72hours
measure: AUCt
timeFrame: 0~72hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Jae-Yong Chung
state: Seongnam-si
Study officials:
References:
Clinical trial NCT01384487: Nidek RS3000 Comparative Study
Official title: Comparative Study of the Nidek Optical Coherence Tomography RS-3000 and the RTVue OCT Predicate Device for the Measurements of Retinal and RNFL Thickness, Optic Disc Analysis, Pachymetry, Anterior Chamber Imaging and SLO Imaging.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Retinal Disease
Corneal Disease
Keywords: Viewing and axial cross sectional imaging of ocular
structures, including the anterior chamber
Lead sponsor: Nidek Co. LTD.
Sponsor class: INDUSTRY
First posted: 2011-06-29
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The primary objective of this clinical study is to compare the Nidek RS-3000 Optical Coherence Tomography (OCT) device to the Optovue RTVue OCT. The secondary objective is to evaluate any adverse events found during the clinical study.


Eligibility criteria: Inclusion Criteria:

1. Subjects of legal age and who have full legal capacity to volunteer on the date the informed consent is signed.
2. Subjects who follow the instructions by Principal/Clinical Investigator or clinical staff at the clinical site, and can visit on a scheduled examination date.
3. Subjects who sign an informed consent form to participate in the clinical study.
4. Subjects who agree to take the qualifying examination and RS-3000 and RTVue data acquisition.

Exclusion Criteria:

1. Diabetes mellitus (DM) and/or diabetic retinopathy
2. Hypertension (HT)
3. Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
4. Cardiac, hepatic, renal and hematologic diseases
5. Current systemic administration of steroid
6. History of anticancer agent etc.
7. Optically-stimulated epileptic seizure
8. Dementia
9. Subjects who have other life threatening and debilitating systemic diseases

NOTE: Additional detailed inclusion/exclusion ophthalmic criteria dependent upon study population also exist

Primary outcomes:
measure: Total Retinal Thickness
timeFrame: One Visit
measure: Inner Retinal Thickness
timeFrame: One Visit
measure: Outer Retinal Thickness
timeFrame: One Visit
measure: RNFL Thickness
timeFrame: One Visit
measure: Optic Disc Analysis
timeFrame: One Visit
measure: G Chart
timeFrame: One Visit
measure: Anterior Chamber Angle Image
timeFrame: One Visit
measure: SLO Image
timeFrame: One Visit
measure: Pachymetry
timeFrame: One Visit
Secondary outcomes:
measure: Any adverse events
timeFrame: One Visit
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Hamilton Glaucoma Center
state: California
Study officials:
affiliation: UCSD, Hamilton Glaucoma Center
name: Robert Weinreb, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00856687: A Study To Assess The Effect Of PF-03893787 On Lung Function Following An Allergen Challenge In Asthmatic Subjects
Official title: A Randomized, Double-Blind (3rd Party Open), Double-Dummy, Placebo- And Active Controlled, 3-Way Crossover Study To Determine The Effects Of Oral PF-03893787 On Allergen-Induced Airway Responses In Mild Asthmatic Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Asthma Allergen Challenge
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: PF-03893787, a novel anti-inflammatory agent should attenuate the effect of a bronchial allergen challenge on lung function and hence provide proof of mechanism for this agent.


Eligibility criteria: Inclusion Criteria:

* Males and females 18-60 years.
* Mild asthma
* Atopic to allergens

Exclusion Criteria:

* Unstable asthma.
* Smokers or recent ex-smokers
* Recent allergen challenge

Primary outcomes:
measure: Spirometry pre- and post- bronchial allergen challenge
timeFrame: 2 months
Secondary outcomes:
measure: Laboratory safety tests
timeFrame: 2 months
measure: 12-lead ECGs
timeFrame: 2 months
measure: Adverse Event reporting
timeFrame: 2 months
measure: Blood samples for pharmacokinetic measurement
timeFrame: 2 months
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02858687: Improving the Diagnosis of Tonsillitis in Emergency Rooms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillitis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 312
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of tonsillitis caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC tonsillitis tests . This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of tonsillitis after POC tests.

The objective of this study is to implement a new diagnosis strategy relying on the hypothesis that a second pharyngeal swab would improve the etiological diagnosis of tonsillitis of at least 5%.


Eligibility criteria: Inclusion Criteria:

* Patient admitted at hospital for tonsillitis requiring, for the emergency physician, a microbiological examination with a "POC tonsillitis kit."
* Patient who has freely signed the informed written consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Pregnant woman, parturient or nursing
* Adult patient under guardianship
* Patient deprived of liberty under court order
* Patient refusing or unable to sign the informed consent form.

Primary outcomes:
measure: Percentage of patients admitted for tonsillitis with a confirmed etiological diagnosis of tonsillitis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Catherine GEINDRE
role: STUDY_DIRECTOR
References:
Clinical trial NCT01881087: Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy
Official title: Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy: A Double Blind, Randomized Clinical Trial Comparing Three Low Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Disorder of Knee
Anesthesia
Keywords: Knee Arthroscopy
Levobupivacaine
Spinal Anesthesia
Motor Block
Lead sponsor: Fundacion Clinica Valle del Lili
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate motor block probability throughout time and clinical profile when using three different doses of HLBP 0.75% (7.5, 9.37 and 11.25 mg) by a unilateral spinal block technique.

Detailed description: Previous IRB approval and informed consent, 180 ASA I-II adults under ambulatory knee arthroscopy will be randomly allocated to receive unilateral spinal anesthesia with 7.5 (group Levo-7.5, n=59), 9.37(group Levo-9.37, n=61) and 11.25 (group Levo-11.25, n=60) mg of HLBP 0.75% using a 27-gauge Whitacre needle at a rate of 0.1 ml/ seg. and lateral decubitus position maintained for 5 min after injection.

An independent observer will evaluate motor (modified Bromage scale) and sensory (transcutaneal electrical stimulation at T10, L1, L3, and S1 dermal segments) levels and presence of adverse events immediately after return to supine, at the end of surgery and each 10 min from admission to PACU until home discharge conditions.

Trans-cutaneal electrical stimulation (TES) will be made with a PNS (Ministim® model MS- IV, Organon, Dublin, Irland) using 50-Hz tetanus stimuli for 5 seg. from 10 to 60 mA 3,4.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-64 y.o. scheduled for knee arthroscopy (therapeutic or diagnostic)

Exclusion Criteria:

* Cardiac or pulmonary disease
* Antiplatelet or anticoagulant drugs use during 7 days before surgery
* History of coagulative disorders
* Bilateral procedures

Primary outcomes:
measure: Probability of Motor Block
timeFrame: 200 minutes
Secondary outcomes:
measure: Failed Spinal Block Rate
timeFrame: 15 minutes after dose
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Fundación Valle del Lili
state: Valle del Cauca
Study officials:
affiliation: Fundacion Clinica Valle del Lili
name: Fredy J Ariza, MD., MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Unidad de Investigaciones Clínicas, Fundación Valle del Lili
name: Marisol Badiel, MD., MSc.
role: STUDY_CHAIR
References:
Clinical trial NCT03175887: Investigational TMS Treatment for Depression
Official title: Dorsolateral Versus Medial Prefrontal TMS for Depression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Treatment Resistant Depression
Keywords: depression
trd
treatment-resistant depression
TMS
Lead sponsor: White River Junction Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2017-06-05
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed to help us learn about the effects of Transcranial Magnetic Stimulation at the forehead versus the left side of the head for treatment of Treatment Resistant Depression.

Detailed description: While transcranial magnetic stimulation (TMS) to the left dorsolateral prefrontal cortex (DLPFC) is an FDA approved treatment for depression, a growing and converging database suggests the medial prefrontal cortex (MPFC) may be even more critical to the neurobiology of depression and antidepressant treatment response. This study will compare the efficacy of high frequency transcranial madntic stimulation on these two sections of the brain.

Eligibility criteria: Inclusion Criteria:

* 21-70 years old
* inadequate response to one current antidepressant medication
* currently depressed

Exclusion Criteria:

* psychiatric comorbidities

Primary outcomes:
measure: Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale
timeFrame: Change from baseline Hamilton-17 score to follow-up visit at 1 week after final TMS intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: White River Junction
country: United States
facility: White River Junction VA Medical Center
state: Vermont
Study officials:
References:
Clinical trial NCT04226287: Compact Pneumatic Compression Device for Patients With Lymphedema
Official title: Pilot Study of a Compact Pneumatic Compression Device for Patients With Lymphedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema of Limb
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2020-01-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a pilot study for usability and efficacy, and as such it is designed for 15 participants.

The primary objective of this study is to assess the usability of the Monterey Investigational System in the home setting.

The primary objective of this study is to assess the usability of the Monterey Investigational System in the home setting over one week of daily use. Usability will be determined using a 11 point Likert Scale where a score of 10 is considered very favorable and a score of 0 is very unfavorable.


Eligibility criteria: Inclusion Criteria:

* Patients who are ≥ 18 years, mentally able to understand and follow the instructions of the study personnel.
* A diagnosis of lower limb Lymphedema.
* Able to provide written and informed consent.
* Patient can read and comprehend English.

Exclusion Criteria:

* Subject undergoing cancer treatment.
* Subject has active lower limb wounds.
* Subject is pregnant or trying to become pregnant.
* History of pulmonary edema or decompensated congestive heart failure.
* Subject has any condition in which increased venous and lymphatic return is undesirable.
* Subject has inbuilt electrical stimulator, e.g., cardiac pacemaker

Primary outcomes:
measure: Usability of the Monterey Investigational System in a monitored clinic environment
timeFrame: 1 week
Secondary outcomes:
measure: Efficacy of Therapy provided by Monterey Investigational system
timeFrame: 1 week
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Progressive Physical Therapy and Rehab
state: California
Study officials:
References:
Clinical trial NCT05554887: Effect of Thoracic Manipulation on Latent Trigger Point
Official title: Effect of Thoracic Manipulation on Muscle Strength and Pressure Pain Threshold in Healthy Individuals With Rhomboid Latent Trigger Point: A Randomized Sham Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigger Points
Keywords: latent trigger point
thorasic manipulation
muscle strength
pressure pain threshold
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised sham controlled study involving 2 parallel groups
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of one session thoracic manipulation on pressure pain threshold and rhomboid muscle strength in healthy individuals with latent trigger point.

Detailed description: Within the scope of the study, all individuals studying at Sarayköy Vocational School and volunteering to participate in the study will be screened.Immediately after determining the latent trigger points in the rhomboid muscles, the participants will be randomized by computer method and divided into 2 groups. Participants who underwent thrust thoracic manipulation will form the study group, and participants who received sham thrust thoracic manipulation will form the control group.Pressure pain threshold will be evaluated with an algometer and rhomboid muscle strength will be evaluated with a hand dynamometer.

Eligibility criteria: Inclusion Criteria:

* not having any systemic disease
* not having any neuromuscular deficit
* To be defined as inactive (less than 30 minutes of moderate physical activity five times a week) according to the minimum activity guidelines published by the American College of Sports Medicine

Exclusion Criteria:

* Being actively involved in any sport
* Participating in a regular exercise program

Primary outcomes:
measure: pressure pain threshold
timeFrame: up to 3 months
measure: rhomboid muscle strength
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Şule Şimşek
state: Sarayköy
Study officials:
affiliation: Phd faculty member
name: Şule Şimşek, Phd
role: STUDY_DIRECTOR
References:
citation: Hanney WJ, Puentedura EJ, Kolber MJ, Liu X, Pabian PS, Cheatham SW. The immediate effects of manual stretching and cervicothoracic junction manipulation on cervical range of motion and upper trapezius pressure pain thresholds. J Back Musculoskelet Rehabil. 2017 Sep 22;30(5):1005-1013. doi: 10.3233/BMR-169573.
citation: The effect of lower cervical and upper thoracic spinal manipulative therapy on pressure algometer readings of rhomboid and infraspinatus muscles by influencing the fascial tension of the spiral line: Doctoral dissertation, Johannesburg: University of Johannesburg, 2015.
Clinical trial NCT01669187: The Effects of Pre-operative Physical Therapy Education
Official title: Phase 1 of the The Effects of Pre-operative Physical Therapy Education and Exercise on Patient Outcomes Post Breast Cancer Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Oakland University
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is expected that patients who receive physical therapy before surgery will have greater range of motion (ROM), strength, function, satisfaction, and less swelling, pain, and anxiety following surgery compared to those in the control group.


Eligibility criteria: Inclusion Criteria:

* be over the age of 18,
* have a good understanding of the English language, and
* be scheduled to undergo either a mastectomy, lumpectomy, ALND or Sentinel Lymph Node Dissection (SLND) with or without breast reconstruction.

Exclusion Criteria:

* if they previously underwent one of the previously mentioned procedures mastectomy, lumpectomy, ALND or Sentinel Lymph Node Dissection (SLND) with or without breast reconstruction.

Primary outcomes:
measure: Change in score for Shoulder Pain and Disability Index (SPADI)
timeFrame: Before sugery (range 0-4 weeks before surgery), 2 weeks post operatively and 6 weeks post-operatively
Secondary outcomes:
measure: Change in Shoulder range of motion with goniometer
timeFrame: Pre-operatively (0-4 weeks pre-operatively), 2 and 6 weeks post-operatively
Other outcomes:
measure: Change in other physical therapy test and measures
timeFrame: Once pre-operatively (0-4 weeks before surgery), 2 and 6 weeks after surgery
Locations:
city: Saginaw
country: United States
facility: St-Mary's of Michigan
state: Michigan
city: Saginaw
country: United States
facility: St. Mary's of Michigan
state: Michigan
Study officials:
affiliation: Oakland University
name: Marie-Eve S Pepin, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00162487: Genetic Determinants of the Hypokalemic and Hyperglycemic Effect of Albuterol Inhalation
Official title: Evaluation of β2 Genetic Polymorphisms and the Effect of Albuterol Inhalation on Potassium and Glucose Plasma Concentration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperkalemia
Chronic Renal Failure
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Several studies have indicated that albuterol administered either intravenously or by inhalation can significantly reduce plasma potassium concentration in patients suffering from chronic renal failure.In conjunction with the decrease in potassium concentration a modest rise in glucose concentration is usually noted. These metabolic effects are characterized by rapid onset occurring as early as 3-5 minutes following salbutamol administration and lasting for at least 1 hour.

The role played by ß2AR polymorphisms in determining the bronchial and vascular response to ß2AR agonist drugs, have been confirmed by several studies.

The purpose of the present study is to examine possible causal relationships between genetically based alteration in the structure of ß2AR and the metabolic effects of inhaled albuterol.


Eligibility criteria: Inclusion Criteria:

* patients regularly attending the nephrological clinic or the dialysis unit
* persistent potassium concentration above 5 mEq/L

Exclusion Criteria:

1. Patients suffering from active ischemic heart disease
2. Patient with a recent history of arrhythmia
3. Patients treated regularly with ß blockers
4. Patients treated regularly with salbutamol or other ß2AR agonists
5. Patients suffering from persistent tachycardia (pulse \> 100 beats/min)
6. Patients who are hemodynamically unstable
7. Patients suffering from any acute illness

Primary outcomes:
measure: The extent of decrease in plasma potassium concentration
measure: The extent of increase in plasma glucose concentration
measure: Plasma concentration of albuterol
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Yoseph Caraco, MD
role: PRINCIPAL_INVESTIGATOR
References: