louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05677035: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LINO-1713 in Healthy Korean Female Subjects
Official title: A Single-center, Open-label, Parallel-group, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LINO-1713 in Healthy Korean Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Contraception
Lead sponsor: Hyundai Pharm
Sponsor class: INDUSTRY
First posted: 2023-01-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A single-center, open-label, parallel-group, phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of LINO-1713 in healthy Korean female subjects


Eligibility criteria: Inclusion Criteria:

* Women with a Body Mass Index (BMI) between 18kg/m2 \~ 28kg/m2

Exclusion Criteria:

* Clinically significant cardiovascular disease, respiratory disease

Primary outcomes:
measure: Pharmacokinetics parameters: Cmax
timeFrame: Before and after administration 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144, and 168 hours
measure: Pharmacokinetics parameters: Tmax
timeFrame: Before and after administration 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144, and 168 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
Clinical trial NCT00821535: Investigation Of Safety And Pharmacokinetics Following A Single Oral Dose Of 300 Mg Maraviroc In Healthy Male Japanese Volunteers
Official title: An Open Label Single Dose Study To Investigate Safety And Pharmacokinetics Of Maraviroc Following A Single Oral Dose Of 300 Mg Maraviroc (Two 150 Mg Maraviroc Commercial Tablets) Under Fasting Conditions In Healthy Male Japanese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Immunodeficiency Virus (HIV) Infection
Keywords: pharmacokinetics, Japanese, healthy volunteer, maraviroc
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2009-01-13
Enrollment: 12
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg maraviroc in healthy male Japanese volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male Japanese subjects between the ages of 21 and 50 years inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Positive result for HIV, Hepatitis B surface antigen (HbsAg) or HCV antibody.
* Hypersensitivity/allergic reactions to any component of maraviroc, including soy lecithin.

Primary outcomes:
measure: Plasma and urine maraviroc concentrations for pharmacokinetic analysis
timeFrame: pre-48 hrs post dose
measure: Adverse event monitoring
timeFrame: Day 0 to Day 3
measure: Bood pressure, pulse rate
timeFrame: Day 0, Day 1, and Day 3
measure: Blood and urine safety laboratory tests
timeFrame: Day 0 and Day 3
measure: ECG
timeFrame: Day 0 and Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02594358: Caffeine in Amblyopia Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Amblyopia
Keywords: Caffeine
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective data on the visual acuity response in children treated by patching concurrently treated with caffeine and estimate the magnitude of effect that might be seen in a randomized trial (if no improvement in acuity is seen, this would be sufficient evidence to decide not to conduct a randomized, double blind trial).

Collect prospective data on the tolerability of caffeine in two dosages as an adjuvant treatment for amblyopia and provide limited data on its safety.

Evaluate the potential for a dietary intervention to enhance the acceptance and tolerability of patching on the child and family.

Demonstrate recruitment potential of subjects to participate in a dietary intervention study.


Eligibility criteria: Inclusion Criteria:

* Amblyopia from strabismus and amblyopia

Exclusion Criteria:

* Known intolerance to caffeine
* Diagnosis and/or treatment of attention deficit/hyperactivity disorder
* Presence of an ocular cause for reduced visual acuity
* Myopia with a special equivalent -6.00 diopters
* Current vision therapy or orthoptics - any type
* Ocular cause for reduced visual acuity
* Prior intraocular or refractive surgery
* History of narrow-angle glaucoma
* Strabismus surgery planned within 16 weeks
* Nystagmus per se does not exclude the subject if the above visual acuity criteria are met
* Known skin reactions to patch or bandage adhesives
* Known allergy or intolerance to food dyes
* Current treatment with topical atropine eyedrops
* Menarche, pregnancy or lactation
* Use of any of the following medications which may affect caffeine metabolism: nafcillin, verapamil, fluvoxamine, ciprofloxacin and other fluoroquinolones, modafinil, nafcillin, and omeprazole

Primary outcomes:
measure: Visual acuity
timeFrame: 12 weeks
Secondary outcomes:
measure: Questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Michael X Repka, MD, MBA
role: STUDY_CHAIR
References:
Clinical trial NCT05793658: Role of Respiratory Rate Derived From Capnography in Sedated Patients
Official title: Is Respiratory Rate Derived From Capnography Can Prevent Adverse Events Occurred in Sedated Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation Problems
Keywords: Sedation
capnography
Respiratory rate
colonoscopy
Lead sponsor: Al Jedaani Hospital
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Although appropriate sedation is recommended during colonoscopy, patients are at risk for adverse events e.g hypoventilation and hypoxemia due to inadvertent oversedation. The aim of this study was to evaluate the benefit of additional quantitative capnography monitoring ( respiratory rate )in management of patient undergoing colonoscopy under sedation in preventing or reducing the incidence of adverse events and also determine when to start the procedure and when to give and not to give increments of sedative drugs during the procedure.


Eligibility criteria: Inclusion Criteria:

* ASA 1 and 2 adult patients
* Age from 20 to 50 years old
* elective colonoscopy

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) above Class II
* History of psychiatric or neurological disease

Primary outcomes:
measure: Hypoxemia
timeFrame: 1 hours
Secondary outcomes:
measure: Patient movements during the procedure
timeFrame: 1 hour
measure: Effort exerted by the anesthesiologist ( the provider)
timeFrame: 1 hour
measure: Patient satisfaction
timeFrame: 1 hour
measure: Gastroenterologist satisfaction
timeFrame: 1 hour
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Al Jedaani group of hospitals
state: Meccah
Study officials:
References:
Clinical trial NCT04159558: Development and Evaluation of mHealth Solutions to Monitor and Involve Cardiometabolic Patients in Self-care
Official title: Development and Evaluation of mHealth Solutions to Monitor and Involve Cardiometabolic Patients in Self-care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Diabetes
Heart Failure
Copd
Asthma
Obesity
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To develop, using barcode systems and virtual pillbox (TuMedicina and Alice), an App aimed at patients and carers of patients with cardiometabolic diseases as the main diagnosis, over 45 years of age, who have one or more pathologies and use one or more drugs on a daily basis and to analyze their effectiveness in terms of achieving therapeutic objectives, self-efficacy and self-efficacy in self-care or provision of care (as the case may be), healthy behavior, therapeutic compliance and safe use of medication.

Detailed description: In order to achieve the objective of this study, an experimental study will carry out on patients with cardiometabolic and respiratory diseases and their caregivers. A participation of 100 patients and 85 caregivers is planned. The aim is for them to use the mobile application developed over three months in order to evaluate their health improvement comparing several clinical and analytic parameters before and after the use of the App, and also evaluating the satisfaction of the participants.

Eligibility criteria: Inclusion Criteria:

* Cardio-metabolic disease, respiratory disease or neurologic disease

Exclusion Criteria:

-

Primary outcomes:
measure: Satisfaction with the mobile application assessed by an ad hoc questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: Treatment adherence assessed by Morisky Medication Adherence Scale (MMAS)
timeFrame: 3 months
Other outcomes:
measure: Health goals compliance assessed by an ad hoc questionnaire
timeFrame: 3 months
Locations:
city: Elche
country: Spain
facility: Miguel Hernández University
state: Alicante
Study officials:
References:
Clinical trial NCT04218058: Reduction of Zygomatic Arch in Zygomaticomaxillary Fractures
Official title: Ultrasound Guided Closed Reduction Versus Open Reduction of Zygomatic Arch in Zygomaticomaxillary Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Zygomatic Arch Reduction
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare between ultrasound guided closed reduction and open reduction of zygomatic arch in cases of zygomaticomaxillary fracture.

To evaluate the role of intra-operative ultrasound during zygomatic arch reduction.

To compare between esthetic appearance, orbital movement, wound healing, scaring, and postoperative ocular complications in both groups.


Eligibility criteria: Inclusion Criteria:

* Patients presenting with ZMC fractures that require reduction and fixation
* Patients between 20 to 50 years old with no gender predilections

Exclusion Criteria:

* Existence of infection at the fracture line
* Chronic systemic diseases such as metabolic bone disease, immunocompromised status

Primary outcomes:
measure: zygomatic arch reduction
timeFrame: immediate post operative CT scan
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Dentistry
Study officials:
References:
Clinical trial NCT00210158: Intraoperative Nitrous Oxide and Postoperative Pain for Patients With Current Opioid Treatment
Official title: Effects of Intraoperative Nitrous Oxide on Postoperative Pain for Patients With Current Opioid Treatment After Vertebroplasty.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Current opioid treatment
Nitrous oxide
Chronic pain
Opioid therapy
Postoperative hyperalgesia
Acute opioid tolerance
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peroperative opioids are known to induce N-Methyl-D-Aspartate dependent enhancement of postoperative hyperalgesia. For patients with current opioid treatment, these phenomena could be exagerated and could produce greater postoperative opioid consumption and higher pain score. Since Nitrous oxide has anti- N-Methyl-D-Aspartate properties, the aim of this study was to evaluate, in patients with current opioid treatment, the effects of peroperative Nitous oxide on postoperative opioid consumption and pain score, after vertebroplasty.


Eligibility criteria: Inclusion criteria:

\> 18 years old Current opioid treatment \> 1 month patients scheduled to undergo vertebroplasty with general anesthesia

Primary outcomes:
measure: Visual Analogue Scale (VAS) and morphine consumption recorded for 48 postoperative hours (every 8 hours).
Secondary outcomes:
measure: Preoperative and postoperative pressure pain threshold (pressure algometer)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer DE Bordeaux et du Sud Ouest
Study officials:
affiliation: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
name: Fabrice LAKDJA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04410458: Recruit Blood Donors Via SMS During Epidemic of COVID-19 （Repeat Trial）
Official title: Recruit Blood Donors Via SMS With Different Contents During Epidemic of COVID-19（Repeat Trial）
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Donation
Lead sponsor: Guangzhou Blood Center
Sponsor class: OTHER_GOV
First posted: 2020-06-01
Enrollment: 506517
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The fight against the spread of the 2019-nCoV epidemic has achieved some success in China, but the epidemic is far from over. A key factor making the epidemic under control in China is the government's call for social distance, which has led to few people going out for donation. As a result, the number of blood donors on the streets has been continuing to decline. The first urgent recruitment of blood donors had been implemented during the period from 30 April to 10 May via emergency recruitment SMS . This repeat trial has been designed to further confirm the results from the the first recruitment by comparing which information extraction frameworks would be more sensitive to blood donors in emergency situations.

Detailed description: Researches has showed that that the information extraction and processing in emergency was different from the normal situation. To understand what information the blood donors are more sensitive to in an environment that may pose a potential threat to themselves, the first urgent recruitment of blood donors had been implemented during the period from 30 April to 10 . This interventional study is the repeat trail of the first trail. The same with first trail, eligible blood donors in Guangzhou Blood Center has been randomly divided into four groups according to their sociological variables, their interval since last blood donation , their history donation times and the location of their last blood donation. Three groups of donors has been randomly selected as interventional groups, and will receive three kindly of emergency blood donor recruitment SMS respectively. The placebo group donors will only receive a thank-you SMS. One recruitment SMS will emphasize what blood services will do to ensure the safety of blood donors during their donation in 2019-nCoV epidemic,one will shows information about a loss-based framework, while the third one will show information about a benefit-based framework .

Eligibility criteria: Inclusion Criteria:

* Blood donors whose last turning up were between November 31, 2016 to November 31, 2019

Exclusion Criteria:

* Blood donors who were deferral by blood screening result and other situations. Blood donors who have indicated that they would not accept urgent recruitment.

Primary outcomes:
measure: Blood donation rate
timeFrame: 12 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Blood Center
state: Guangdong
Study officials:
References:
Clinical trial NCT06084858: Effect of Changes in Dialysate Bicarbonate on Serum Calcification Propensity and Calciprotein Particles in Hemodialysis Patients
Official title: Effect of Dialysate Bicarbonate Prescription on Serum Calcification Propensity and Calciprotein Particles in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: Elisabethinen Hospital
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: This is a single-center, prospective, proof-of-priciple, pilot study. Bicarbonate for dialysis will be modified step-by-step from 27 mmol/l to 37 mmol/l.
Primary purpose: DIAGNOSTIC

Brief summary: This is a single-center, prospective, proof-of-priciple, pilot study in 24 end-stage renal disease patients on chronic hemodiaysis.

Detailed description: This single-arm, proof-of-principle study will be conducted at the dialysis facility of the Ordensklinikum Linz Elisabethinen Hospital. The dialysate bicarbonate prescription will be decreased from standard of care (usually 35mmol/l) in a stepwise fashion (2 mmol/l per change) to 27 mmol/l and subsequentially increased in a stepwise fashion (2 mmol/l per change) to 37 mmol/l over the course of 6 weeks.

Eligibility criteria: Inclusion Criteria:

* age ≥18 years
* chronic (≥3 months) treatment with hemodialysis or hemodiafiltration
* stable clinical condition

Exclusion Criteria:

* inability to provide informed consent
* dialysis treatment less than thrice weekly
* morbid obesity (body mass index \>40 kg/m2)
* chronic inflammation (C reactive protein \>10 mg/dL, reference: \<0.5 g/dL)
* current immunosuppressive medication,
* severe chronic obstructive pulmonary disease (COPD stage III or IV)
* history of severe hypercapnia or hypoxemia
* overt congestive heart failure
* history of severe hypokalemia (\<3.0 mmol/l) or hyperkalemia (\>6.5 mmol/L) within 3 months prior to study inclusion.

Primary outcomes:
measure: T50-Laboratory Test for measuring calcification
timeFrame: 6 Weeks
Secondary outcomes:
measure: CPP Levels
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
state: Upper Austria
Study officials:
affiliation: Head of Nephrology
name: Daniel Cejka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03829358: The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation
Official title: The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation: Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Constipation - Functional
Keywords: Constipation
Quality of Life
Probiotic
PAC-QOL
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2019-02-04
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the relationship between administration of probiotics and improvement in quality of life in women with functional constipation.


Eligibility criteria: Inclusion Criteria:

* Being declared healthy based on initial examination and the Structured Interview Questionnaire (SIQ)
* Having the symptoms and signs of functional constipation refer to ROME IV
* Able to communicate well
* Able to consume 1 bottle of fermented milk each day for three weeks
* Not using antibiotic no later than one week before supplementation

Exclusion Criteria:

* Diagnosed with functional bowel disorder
* Using anesthesia at least 4 weeks before treatment
* Having a serious pathological disorder (carcinoma)
* During healing phase of acute gastrointestinal disorders at least 4 weeks before treatment
* Having severe heart disease
* Taking chronic medications such as antidepressants or analgesics

Primary outcomes:
measure: Improvement in quality of life
timeFrame: Three weeks after intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Puskesmas Petamburan
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Hasan Maulahela, MD
role: PRINCIPAL_INVESTIGATOR
References: