louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01080651: Influence of Drug-drug Interactions on the Pharmacokinetics (PK) of Voriconazole
Official title: Clinical Trials to Evaluate the Influence of CYP2C19 Genotype and Drug-drug Interactions on the Pharmacokinetics of Voriconazole in Healthy Korean Male Volunteers (Part B)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Invasive Aspergillosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-03-04
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: To evaluate the drug-drug interaction between rifampicin and voriconazole according to CYP2C19 genotype quantitatively following a single oral administration of 200 mg voriconazole


Eligibility criteria: Inclusion Criteria:

* 1.Healthy male subjects aged 20 - 50 years.
* 2.A body mass index (BMI) in the range 17-28 kg/m2.
* 3.Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully informed about the study procedures.

Exclusion Criteria:

* 1.Presence or history of severe adverse reaction to any drug or a history of severe allergic disease.
* 2.Clinically relevant abnormal medical history that could interfere with the objectives of the study.
* 3.Presence or history of eye disease or eye field defect.
* 4.A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.
* 5.A subject whose liver function test (AST, ALT, GGT, ALP, LDH) result is over 1.25 times of upper limit of normal range.
* 6.A subject whose SBP is over 140 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
* 7.Presence or history of drug abuse.
* 8.Participation in other clinical trial within 2 months.
* 9.Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication within 1 week before first dose.
* 10.Blood donation during 2 months or apheresis during 1 month before the study.
* 11.Presence or history of alcohol abuse.
* 12.Smoking of more than 10 cigarettes/day.
* 13.Use of grapefruit juice, xanthine containing beverage, alcohol or smoking during restriction period.
* 14.Subject judged not eligible for study participation by investigator.

Primary outcomes:
measure: Plasma concentration of voriconazole
timeFrame: pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Clinical Trial Center
Study officials:
affiliation: Professor
name: In-Jin Jang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03119077: Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116
Official title: Randomized, Double-blind, Placebo-controlled, Escalating Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of Orally Administered BAY1161116 in Healthy Postmenopausal Women Including Food-effect and Drug-drug-interaction With Itraconazole
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 32
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will be conducted in a single center, double-blind with 6 dose escalation groups to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of BAY1161116.


Eligibility criteria: Inclusion Criteria:

* Healthy female postmenopausal subjects
* Age: 45 to 65 years (inclusive)
* Body mass index (BMI) : ≥18 and ≤30 kg/m²
* Non-smoker for 3 months (former smokers who quit smoking \>3 months before the first study drug administration may be included)

Exclusion Criteria:

* Incomplete recovery from pre-existing disease for which it can be assumed that the absorption, distribution, excretion,and effect of the study drugs will not be normal
* Any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, from screening to the first drug administration (occasional use of paracetamol or ibuprofen is permissible)
* Any severe disease within the last 4 weeks prior to the first study drug administration
* History of orthostatic hypotension, fainting spells, blackouts
* Any malignant tumor and history thereof
* Any other medical condition which, at the discretion of the investigator, would make study participation unadvisable
* Any clinically relevant finding at the physical- and gynecological examinations
* Allergy, hypersensitivity, or non-allergic drug reactions to any excipient of the IMP or reference/interaction product
* Regular alcohol consumption equivalent to \>20 g alcohol per day
* Urine screen positive for any drug or cotinine

Primary outcomes:
measure: Incidence of TEAEs
timeFrame: 5 weeks
measure: Severity of TEAEs
timeFrame: 5 weeks
measure: AUC of BAY1161116
timeFrame: 5 weeks
measure: Cmax of BAY1161116
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: CRS Clinical Research Services Berlin GmbH
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05988177: Efficacy and Safety of Carrimycin Tablets in HLH Patients With Carbapenem-resistant Infections
Official title: Clinical Study on the Efficacy and Safety of Carrimycin Tablets in Hemophagocytic Lymphohistiocytosis Patients With Carbapenem-resistant Infections
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carbapenem Resistant Bacterial Infection
Hemophagocytic Lymphohistiocytoses
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the efficacy and safety of Carrimycin tablets in hemophagocytic lymphohistiocytosis patients with Carbapenem-resistant infections.

Detailed description: Hemophagocytic lymphohistiocytosis (HLH) is a critical condition characterized by the undue activation of cytotoxic T lymphocytes, natural killer cells, and macrophages, resulting in excessive secretion of infammatory cytokines. Infection is an important trigger for HLH. This study aimed to investigate the efficacy and safety of Carrimycin tablets in hemophagocytic lymphohistiocytosis patients with Carbapenem-resistant infections.

Eligibility criteria: Inclusion Criteria:

* Met HLH-2004 diagnostic criteria;
* Active infection；
* Empirical treatment with carbapenems did not respond after 72 hours；
* Age \>18 years old, no gender limitation;
* Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

* Other antibiotics should be selected according to the results of drug sensitivity；
* Systemic antibiotics other than carbapenems are used with 72 hours；
* Inability to take oral medications due to disease of gastrointestinal tract；
* Severe liver insufficiency;
* Expected survival time \< 1 month;
* Pregnant or breasting-feeding women;
* Allergic to Carrimycin tablets;
* Active hepatitis B or hepatitis C infection;
* Patients with HIV infection;
* Patients with other contraindications considered unsuitable for participation in this study.

Primary outcomes:
measure: Cure rates of infections
timeFrame: 1 week and 2 weeks after initiation of treatment
measure: Overall response rate of HLH
timeFrame: 2 weeks after treatment
Secondary outcomes:
measure: Overall Survival
timeFrame: 1 years
measure: Incidence and Severity of Adverse Events
timeFrame: 28 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhao Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06920277: Ultrasound Image Collection for the Development of an AI Software
Official title: Data Collection for the Development of Artificial Intelligence (AI) Software to Support Ultrasound-Guided Regional Anesthesia Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound Scan
Keywords: Data collection
Artificial Intelligence
Regional Anesthesia
Lead sponsor: Smart Alfa Teknoloji San. ve Tic. A.S.
Sponsor class: INDUSTRY
First posted: 2025-04-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: volunteers from the U.S. population

Brief summary: This study is designed to collect ultrasound images from healthy volunteers in the U.S.

Detailed description: The goal of this study is to create an ultrasound image dataset of healthy volunteers from the U.S. population. This dataset will be used for development of an AI software which will assist anesthesiologists in detection of key anatomical structures on the ultrasound image for peripheral nerve block applications. These blocks are:

* Interscalene Brachial Plexus
* Supraclavicular Brachial Plexus
* Infraclavicular Brachial Plexus
* Cervical Plexus
* Axillary Brachial Plexus
* PECS I \& II
* Transversus Abdominis Plane (TAP)
* Rectus Sheath
* Femoral Nerve
* Adductor Canal
* Popliteal Sciatic
* Erector Spinae Plane (ESP)

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* At least 18 years of age and older
* Stated willingness to comply with all study procedures and availability for the duration of the study
* In good general health

Exclusion Criteria:

* Pregnancy
* Inability to lie to flat
* Any complaint or anatomical deformity on the regions to be scanned

Primary outcomes:
measure: Number of ultrasound scan recordings relevant to peripheral nerve blocks collected
timeFrame: Day 1, 2 and 3
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Conference Room at Doubletree by Hilton Austin
state: Texas
Study officials:
affiliation: Smart Alfa Teknoloji San. ve Tic. A.S.
name: Senanur Samur Duysal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04008277: Investigation of Heart Rate Variability During the Menstrual Cycle
Official title: Investigation of Heart Rate Variability During the Menstrual Cycle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovulation
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: In this study, women will be required to wear a heart rate monitor continuously and collect daily early morning urine samples for the duration of one complete menstrual cycle. This will enable comparisons between data collected from the heart rate monitor and hormone analysis in urine samples to be made.

Detailed description: This pilot study is a prospective observational study of women's heart rate and heart rate variability throughout one complete menstrual cycle. A minimum of 10 volunteers aged 18 years of age or over will be recruited via a variety of methods according to the criteria detailed in section 9. They will be required to wear a heart rate monitor continuously and collect daily early morning urine samples throughout one menstrual cycle.

Urine samples will be returned to SPD on a regular basis for measurement of urinary hormones related to pregnancy and fertility. Data collected via the monitor including heart rate and heart rate variability will be downloaded for comparison.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and over
* Regular menstrual cycles

Exclusion Criteria:

* Taking any hormonal medications
* Taking any medications that may affect heart rate
* Known heart condition or use of a pacemaker
* Skin condition where there is sensitivity to wearing a skin monitor
* Currently suffering with anxiety or panic attacks
* Pregnant or breastfeeding

Primary outcomes:
measure: Heart Rate
timeFrame: 1 month
measure: Heart Rate Variability
timeFrame: 1 month
Secondary outcomes:
measure: Day of ovulation
timeFrame: 1 month
measure: Fertile window
timeFrame: 1 month
measure: Fertile window closure
timeFrame: 1 month
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: SPD Development Company Ltd.
state: Bedfordshire
Study officials:
affiliation: SPD Development company Ltd.
name: Sarah Johnson
role: STUDY_DIRECTOR
References:
Clinical trial NCT02153177: The Effect of NSAIDs After a Rotator Cuff Repair Surgery.
Official title: The Effect of NSAIDs After a Rotator Cuff Repair Surgery. A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Rotator Cuff Tear
Keywords: Randomized Controlled Trial (RCT)
RCT
rotator cuff tear
NSAIDs
non-steroidal anti-inflammatory drugs
rotator cuff repair
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of the study is to determine the effect of Non-steroidal Anti-inflammatory Drugs (NSAIDs) on the healing process after a rotator cuff repair procedure.

Detailed description: Furthermore, the study will also determine the rate of narcotic medications use and the retear rate after a rotator cuff repair procedure.

Eligibility criteria: Inclusion Criteria:

* rotator cuff tear
* age 45-75 years

Exclusion Criteria:

* diabetes
* pregnancy
* chronic kidney disease
* liver cirrhosis
* hematologic malignancy
* alcohol abusing
* drug abusing

Primary outcomes:
measure: American Shoulder and Elbow Surgeons (ASES) Shoulder Score
timeFrame: one year
Secondary outcomes:
measure: Ultrasound evaluation of retear rate
timeFrame: one year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Lewis L Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04653077: MSCs Therapy for Cerebral Palsy
Official title: Bone Marrow Stem Cells Transplantation for the Treatment of Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stem Cell Transplant Complications
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: AMR KHALIL ORTHOPEDIC SURGERY CENTER
First posted: 2020-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cerebral palsy (CP) is the most common physical disability in childhood. CP comprises a heterogeneous group of disorders that are the result of a non-progressive disruption or injury that occurred during fetal brain development or within the first two years of life.

Detailed description: This disruption can result in spasticity, dystonia, muscle contractures, weakness and difficulty in coordination that ultimately affects the ability to control movements. Resultant activity limitations may affect gross motor movements, fine motor movements, speech and communication, as well as eating and drinking.

Eligibility criteria: Inclusion Criteria:

* • Must be more than 2 year of age and less than 12 years of age at the time of screening for inclusion in the study.

  * Clinical evidence of a non-progressive motor disability due to brain dysfunction.

Exclusion Criteria:

* • Intractable seizures

  * Traumatic brain injury
  * Genetic disorder
  * Current Infection
  * Renal insufficiency
  * Hepatic disease
  * HIV+ (as demonstrated by positive blood test)
  * Immunosuppression

Primary outcomes:
measure: Changes in Motor Performance.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Aljazeera( Al Gazeera) hospital
Study officials:
References:
Clinical trial NCT04052477: Social Web Mining for Suicide Prevention
Official title: Social Web Mining for Suicide Prevention of Young People
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicidal Behaviors
Keywords: Suicide
Prevention
Social network
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: LIRMM - Montpellier - France
First posted: 2019-08-09
Enrollment: 9
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (major or minor) presenting suicidal behaviors (recent suicide attempt or suicidal ideations)

Brief summary: According to a recent and alarming WHO (World Health Organisation) report (September 4, 2014), one person dies of suicide every 40 seconds in the world. Suicide is the third-leading cause of death for 15- to 24-year-olds, according to the Centers for Disease Control and Prevention , after accidents and homicide.

This major public health issue need prevention strategies especially directed to at-risk populations. Since 2013, more than 2 billion users are enrolled in social networks such as Twitter or Facebook. Young adults (ages 18 to 29) are the most likely to use social media - fully 90% do.

Consequently, in this project, we focus on suicide prevention in social media network..

The aim of this project is the validation of the algorithm. This algorithm build a decision support system that monitor young people at-risk based on large volume of heterogeneous data collected through social media to improve suicide prevention.

Detailed description: This study is composed of two steps :

1. 9 subjects were recruited. After patients agreement, computer scientists were accessing to patient social network profile. Computer scientists were not able to visualize the content of publications, just run the algorithm that will analyse the content of messages (text, frequency, emoticons...)

   The algorithm defines the 3 most at-risk periods of suicide behaviors, on the next month. This result were compared to periods found by psychiatric interview. The psychiatrist then confirmed or not to LIRM whether periods found by the algorithm conrrespond to those defined by the psychitrist. No data of the social network were collected.
2. the 2nd step aim to improve the algorithm by collecting sociodemographic and clincal data related to patients included.

Eligibility criteria: Inclusion criteria:

* Major patient
* Minor patient with parents approval
* Patient hospitalized due to suicide attempt or suicide ideations
* Frequent active user of social netword (Facebook, Instagram, Youtube, Twitter)

Exclusion criteria:

- Patient's refusal to participate

Primary outcomes:
measure: sensitivity of the algorithm
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Sébastien Guillaume, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04064177: Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study
Official title: Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Output, Low
Cardiac Output, High
Blood Pressure
Keywords: Blood Pressure
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 148
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All term and preterm infants (24-42 weeks of gestational age) for the validation study and preterm infants with fetal growth restriction for the longitudinal study.

Brief summary: This is an observational study in newborn term and preterm infants. The study will validate if non-invasive continuous cardiac output monitoring is feasible in newborn infants, if normative values can be constructed and what is the effect of fluid boluses and inotropes on cardiac output and peripheral vascular resistance.

Detailed description: This is a 3-year prospective observational study.

Principal research question:

Is non-invasive continuous cardiac output (CO) measurement a validated tool of comprehensive cardiovascular assessment in neonatal intensive care (NICU)?

Secondary research questions:

1. Can robust normal ranges of CO be constructed for neonates undergoing cardiovascular measurement?
2. How do neonatal interventions (fluid boluses, ventilation and inotropes) affect CO?
3. Does the Non-invasive continuous cardiac output monitoring in children with foetal growth restriction (FGR) differ from normative CO data as above (1)?

A prospective study of stable newborn babies in the postnatal ward and sick term and preterm infants in the NICU in 36 months.

Eligibility criteria: Inclusion Criteria:

* Healthy term infants in postnatal ward (within the first 72 hours of age)
* Term and Preterm infants (including those with FGR) admitted to the neonatal unit
* Written informed parental consent (prospective for postnatal ward and retrospective for babies admitted to the neonatal units)

Exclusion Criteria:

* Antenatal or postnatal diagnosis of severe congenital anomaly
* Infants with no realistic chance of survival
* Infants who are \>12 hours of age
* Infants with fragile skin not permitting skin probe placement

Primary outcomes:
measure: Haemodynamic outcome comparison to echocardiography measured CO
timeFrame: 36 months
measure: Changes in cardiac output
timeFrame: 36 months
Secondary outcomes:
measure: Changes in clinical outcome - Survival at discharge
timeFrame: 36 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Neonatal consultant
name: Jayanta Banerjee
role: PRINCIPAL_INVESTIGATOR
References: