louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01415349: SSP-002358 Drug Interaction Study With Omeprazole
Official title: A Phase 1, Open-label, Randomized, 2-period Crossover Drug Interaction Study in Healthy Adult Subjects to Evaluate the Effect of the Proton Pump Inhibitor Omeprazole on the Pharmacokinetics of SSP-002358
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-08-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a drug interaction study evaluating whether blood plasma concentrations of SSP-002358-base are altered when SSP-002358 is taken together with omeprazole.


Eligibility criteria: Inclusion criteria:

1. Age 18-55 years inclusive at the time of consent.
2. Subject is willing to comply with any applicable contraceptive requirements of the protocol and is:

   * Male, or
   * Non-pregnant, non-lactating female
   * Females must be at least 90 days post-partum or nulliparous.

Exclusion criteria:

1. Any current or recurrent disease (eg, cardiovascular, renal, liver, gastrointestinal, malignancy or other conditions) that could affect the action, absorption, or disposition of the investigational product, or could affect clinical or laboratory assessments.
2. Any known or suspected intolerance or hypersensitivity to the investigational product or omeprazole, closely related compounds, or any of the stated ingredients.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) for SSP-002358
timeFrame: Assessed over 48 hours post-dose
measure: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358
timeFrame: Assessed over 48 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
facility: PRA International
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00309049: Ixabepilone Administered as an Enteric Coated Formulation.
Official title: An Exploratory Study of Ixabepilone Administered as an Enteric Coated Formulation in Patients With Advanced Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cancer
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2006-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the pharmacokinetics of oral Ixabepilone.


Eligibility criteria: Inclusion Criteria:

* ECOG status of 0-2.

Exclusion Criteria:

* Unable to swallow pills.
* Current or recent GI disease or GI surgery.
* Brain mets.
* Severe nerve damage.
* ANC \<1,500/mm3
* Platelets \<125K.
* Bilirubin \>=1.5 times the IULN.
* ALT/AST \>=1.5 times the IULN.
* Creatine \>1.5 times the IULN.
* Prior treatment with Ixabepilone.
* Strong use of CYPP450 drugs.

Primary outcomes:
measure: Determine the action of Ixabepilone in the body over a period of time including the process of absorption, distribution, metabolism and elimination.
Secondary outcomes:
measure: Determine the rate and extent to which Ixabepilone is absorbed or otherwise available to the treatment site in the body.
Other outcomes:
Locations:
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Detroit
country: United States
facility: Local Institution
state: Michigan
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02750449: Human Photoallergy Test
Official title: Human Photoallergy Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-04-25
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To evaluate the potential of a test material to produce a photo allergic response.


Eligibility criteria: Inclusion Criteria:

* be male or female between the ages of 18 and 60 inclusive;
* be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability Act (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164;
* be in general good health as determined by the subject's medical history and in the discretion of the investigator;

Exclusion Criteria:

* have a visible sunburn;
* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses;
* have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products;
* subjects who are employees of the CRO and/or Bayer or is a household member of an employee;

Primary outcomes:
measure: Intensity of skin reactions is evaluated by 5 point grading scale
timeFrame: Up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01189149: Intravenous Fluids Versus Naso/Orogastric-tube Feeding in Hospitalized Infants With Bronchiolitis
Official title: Intravenous Fluids vs. Naso/Orogastric-tube Feeding in Hospitalized Infants With Acute Viral Bronchiolitis: a Randomized, Controlled, Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Viral Bronchiolitis
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-08-26
Enrollment: 35
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oro- or nasogastric tube feeding is safe and may be more physiologic than intravenous (IV) fluids in hospitalized infants with acute viral bronchiolitis.


Eligibility criteria: Inclusion Criteria:

* Infants with bronchiolitis \< 6 months who need to be hospitalized and are not able to eat per os.

Exclusion Criteria:

* Infants with severe bronchiolitis not allowed to get any gastric feeds or those that their parents will not sign an informed consent.

Primary outcomes:
measure: Clinical outcomes
timeFrame: 3 winters
Secondary outcomes:
measure: Possible side effects of each method (IV vs. Oro/nasogastric feedings)
timeFrame: 3 winters
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Pediatric Department
Study officials:
affiliation: Bnai Zion Medical Center
name: Amir Kugelman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kugelman A, Raibin K, Dabbah H, Chistyakov I, Srugo I, Even L, Bzezinsky N, Riskin A. Intravenous fluids versus gastric-tube feeding in hospitalized infants with viral bronchiolitis: a randomized, prospective pilot study. J Pediatr. 2013 Mar;162(3):640-642.e1. doi: 10.1016/j.jpeds.2012.10.057. Epub 2012 Dec 20.
Clinical trial NCT04669249: Reward-Based Recovery Outcomes Management for Opioid Use Disorder
Official title: PROCare: Cloud Process Support for Opioid Recovery Participation and Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Lead sponsor: Medical Decision Logic, Inc.
Sponsor class: INDUSTRY
Collaborators: name: PRO Health Group
name: National Institute on Drug Abuse (NIDA)
First posted: 2020-12-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized pilot study assessing feasibility, acceptability, and preliminary effectiveness of a reward-based recovery management platform (PROCare) designed to enhance participation in outcomes monitoring, engagement in treatment care, and adherence to medication for opioid use disorder.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* access to internet-enabled smartphone device
* primary DSM-5 opioid use disorder diagnosis
* receiving medication treatment for opioid use disorder with buprenorphine
* English language proficient

Exclusion Criteria:

* active suicidal ideation or psychotic symptoms

Primary outcomes:
measure: Percentage of Participants Fully-Adherent to Buprenorphine
timeFrame: 4-week
measure: Percentage of Participants Fully-Adherent to Care Plan
timeFrame: 4-week
measure: Percentage of Participants Completing Outcomes Monitoring Surveys
timeFrame: 4-week
Secondary outcomes:
measure: Percentage of Participants Using Opioids
timeFrame: 4-week
measure: Percentage of Participants Using Other Substances (Non-opioids)
timeFrame: 4-week
measure: Change in Quality of Life as Assessed by EUROHIS-QOL 8-item Index From Baseline to 4-Week Follow-up
timeFrame: 4-week
measure: Change in Opioid Craving as Assessed by Opioid Craving Scale (OCS) From Baseline to 4-Week Follow-up
timeFrame: 4-week
measure: Motivation as Assessed by Readiness Ruler
timeFrame: 4-week
measure: Change in Self-Efficacy as Assessed by Brief Situational Confidence Questionnaire (BSCQ) From Baseline to 4-Week Follow-up
timeFrame: 4-week
measure: Change in Opioid Use Disorder Impairment From Baseline to 4-Week Follow-up
timeFrame: 4-week
Other outcomes:
measure: Usability of PROCare App as Assessed by System Usability Scale (SUS)
timeFrame: 4-week
Locations:
city: Miami
country: United States
facility: South Florida Behavioral Health Network, Inc.
state: Florida
Study officials:
affiliation: PRO Health Group
name: Steven L Proctor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Decision Logic, Inc.
name: Allen Tien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05132049: Pharmacokinetics and Safety Profiles After Administration of DA-5211 and Co-administration of DA-5211-R1 and DA-5211-R2 in Healthy Adult Volunteers
Official title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of DA-5211 and Co-administration of DA-5211-R1 and DA-5211-R2 in Healthy Adult Volunteer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-23
Enrollment: 42
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pharmacokinetics and safety Profiles after administration of DA-5211 and co-administration of DA-5211-R1 and DA-5211-R2 in healthy adult volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* BMI between 18 and 30 kg/m2
* Body weight: Male≥50kg, Female≥45kg
* Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study

Exclusion Criteria:

* Subjects with allergy or drug hypersensitivity
* Subjects with clinically significant medical history
* Subjects with history of drug abuse or addicted

Primary outcomes:
measure: AUCt
timeFrame: pre-dose~72 hours post-dose
measure: Cmax
timeFrame: pre-dose~72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Bumin Hospital
Study officials:
References:
Clinical trial NCT05900349: Carbohydrate Rinsing and Caffeine Gum on Performance of Romanian Deadlifts Performance
Official title: Carbohydrate Mouth Rinses and Caffeine Gum Increase the Romanian Deadlift Performance on the Flywheel Training Device: A Randomised, Cross-Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carbohydrate
Caffeine
Keywords: Eccentric exercise
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Two experiments were completed to investigate the effects of carbohydrate mouth rinsing and caffeine gum chewing on inertial resistance exercise performance. It was found that both carbohydrate gargling and caffeine gum chewing could improve inertial resistance exercise performance.

Detailed description: This study compared the effects of mouth rinsing with carbohydrates trial (CMR) or a placebo trial (PL) on inertial weight training performance with an inertial weight resistance device. The participants were recruited in this study. Participants were randomly allocated to the CMR and PL groups and subjected to a crossover experiment in which they performed maximum inertial resistance training comprising five sets of six reps, with 3-min rests between sets. After deducting the first repetition of each sets, the mean values from the five sets were analyzed.

Eligibility criteria: Inclusion Criteria:

1. regular weight training habits,
2. familiarity with Romanian deadlift movements
3. no chronic diseases such as hypertension, diabetes, and kidney disease or sports injuries such as lacerated knee ligaments, inflammation and rupture of tendons, strained biceps femoris or quadriceps, and strained biceps within the 6 months prior.

Exclusion Criteria:

1. did not have regular exercise habits,
2. were unfamiliar with Romanian deadlift movements
3. had certain health problems that prevented them from performing exercise or injury from which they had not recovered for more than 6 months were excluded.

Primary outcomes:
measure: average power performance of Romanian deadlifts on flywheel training device
timeFrame: immediately after intervention
measure: concentric peak power performance of Romanian deadlifts on flywheel training device
timeFrame: immediately after intervention
measure: eccentric peak power performance of Romanian deadlifts on flywheel training device
timeFrame: immediately after intervention
Secondary outcomes:
measure: peak overload performance of Romanian deadlifts on flywheel training device
timeFrame: immediately after intervention
measure: average force performance of Romanian deadlifts on flywheel training device
timeFrame: immediately after intervention
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: National Taiwan University of Sport
Study officials:
affiliation: National Taiwan University of Sport
name: ChihHui Chiu, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01194349: The Role of Reactive Thrombocytosis in Children With Pneumococcal Infection
Official title: The Role of Reactive Thrombocytosis in Children With Pneumococcal Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombocytosis
S. Pneumoniae Infection
Keywords: S. pneumoniae
thrombocytosis
pediatric patients
The study aimed to understand the diagnostic value of thrombocytosis in children with S. pneumoniae infection
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
Collaborators: name: University of Alberta
First posted: 2010-09-03
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric hospitalized patients less than 18 year-old.

Brief summary: Thrombocytosis, mostly reactive in nature, is common in pediatric hospitalized patients with infections. Streptococcus pneumoniae (S. Pneumoniae) is the most common pathogen. In this study, the investigators investigated the associations of clinical profiles and thrombocytosis and evaluated platelet counts, leukocyte counts and CRP levels as predictors of hospitalization days in patients with S. pneumoniae infection.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients diagnosed with pneumococcal infection.

Exclusion Criteria:

* Patients with automatic discharge.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Jinn-Li Wang
Study officials:
References:
Clinical trial NCT06550349: ScanNav Anatomy PNB Data Collection Study 2024
Official title: ScanNav Anatomy PNB Data Collection Study 2024
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Data Collection
Lead sponsor: IntelligentUltrasound Limited
Sponsor class: INDUSTRY
First posted: 2024-08-13
Enrollment: 77
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: Healthy adult volunteers.

Brief summary: Study to gather additional data for AI-driven medical device, ScanNav Anatomy PNB.

Detailed description: Volunteer study to gather additional ultrasound training and/or validation data for Artificial Intelligence (AI)-algorithms used in the medical device ScanNav Anatomy PNB.

Eligibility criteria: Inclusion Criteria:

1. Male or female, at least 18 years of age;
2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

1. Aged \<18 years of age;
2. Unwilling or unable to provide informed consent.

Primary outcomes:
measure: Training and/or validation data (in the form of recorded ultrasound scans)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Hodge House
Study officials:
References:
Clinical trial NCT07002749: ROLE OF PROPHYLACTIC TRANEXAMIC ACID IN PREVENTION OF POST-PARTUM HEMORRHAGE IN ELLSCS
Official title: ROLE OF PROPHYLACTIC TRANEXAMIC ACID IN PREVENTION OF POST-PARTUM HEMORRHAGE IN ELLSCS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Post Partum Hemorrhage
Lead sponsor: Patel Hospital, Pakistan
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: IN THIS STUDY WOMEN UNDER GOING ELLSCS WOULD BE DIVIDED INTO TWO GROUPS , ONE GROUP WOULD BE GIVEN TRANEXAMIC ACID WHILE THE OTHER WOULD BE GETTING PLACEBO PROPHYLACTICALLY TO SEE THE EFFECT OF TRANEXAMIC ACID IN PREVENTING PPH.

THIS IS A RANDOMIZED CONTROLLED TRIAL. THE SAMPLING TECHNIQUE WOULD BE NON-PROBABILITY TECHNIQUE RANDOMIZATION WOULD BE DONE VIA BALLOTING METHOD.


Eligibility criteria: Inclusion Criteria:

* Pregnant women with singleton pregnancy and low risk for PPH admitted for ELLSCS

Exclusion Criteria:

Women with medical disorder or complex pregnancy.

* Women with history of PPH.
* Women with bleeding disorder.
* Abnormal placentation (MAP, placenta previa)
* Multiple pregnancy.

Primary outcomes:
measure: prophylactic tranexamic acid in prevention of post-partum haemorrhage in ELLSCS
timeFrame: 6 months from the time of approval from CPSP till the completion of data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Patel Hospital
state: Sindh
Study officials:
References:
Clinical trial NCT00636649: Escitalopram Treatment of Night Eating Syndrome
Official title: Escitalopram Treatment of Night Eating Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Night Eating Syndrome
Keywords: Eating disorder
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: St. Louis University
First posted: 2008-03-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Night-Eating Syndrome (NES) is an eating disorder characterised by excessive eating at night, sleep disturbance and morning anorexia. This 12-week study examines the effect of escitalopram on symptoms of NES.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 years
* Presence of NES
* BMI 25-50

Exclusion Criteria:

* History of schizophrenia or other psychoses
* History of bipolar disorder, anorexia nervosa, bulimia, binge eating disorder
* Current major depressive disorder
* Suicidal ideation
* Psychotropic drugs in the past month
* Drugs or herbal remedies that significantly affect body weight, current participation in a weight loss program, currently following a specialized diet (e.g., Atkins, Zone, etc)
* Lack of benefit with SSRI treatment for NES
* Serious or unstable medical illness
* Allergy or hypersensitivity to escitalopram
* Pregnant, breast-feeding, or planning pregnancy in the next six months.

Primary outcomes:
measure: Night Eating Questionnaire
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Change in Beck Depression Inventory II (BDI-II) Score
timeFrame: Baseline, 12 weeks
measure: Change in Coping Inventory for Stressful Situations (CISS)
timeFrame: Baseline, 12 weeks
measure: Change in Perceived Stress Scale (PSS)
timeFrame: 12 weeks
measure: Change in Three Factor Eating Questionnaire (TFEQ)
timeFrame: Baseline, 12 weeks
measure: Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2
timeFrame: 12 weeks
measure: Change in Lipid Panel
timeFrame: Baseline,12 weeks
measure: Change in Beck Anxiety Inventory (BAI) Score
timeFrame: Baseline, 12 weeks
measure: Change in Glucose
timeFrame: Baseline, 12 Week
measure: Change in Weight
timeFrame: Baseline, 12 week
measure: Number of Participants Who no Longer Meet the NESHI Criteria
timeFrame: Week 12
measure: Number of Participants Who Had a 50% Reduction in NEQ Scores
timeFrame: Week 12
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Kishore Gadde, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vander Wal JS, Gang CH, Griffing GT, Gadde KM. Escitalopram for treatment of night eating syndrome: a 12-week, randomized, placebo-controlled trial. J Clin Psychopharmacol. 2012 Jun;32(3):341-5. doi: 10.1097/JCP.0b013e318254239b.