louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05909553: Study to Assess Adverse Events and Compare How Crushed, Ground, and Intact Oral Tablets Venetoclax Moves Through the Body of Healthy Female Adult Volunteers
Official title: A Phase 1, Open-Label Study to Evaluate the Effect of Crushing and Grinding on the Bioavailability of Venetoclax Tablet in Healthy Adult Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Venetoclax
ABT-199
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the oral bioavailability of crushed and ground venetoclax commercial tablets relative to the intact venetoclax commercial tablets under fed condition in healthy female participants.


Eligibility criteria: Inclusion Criteria:

* Must either be: postmenopausal, permanently surgically sterile, or perimenopausal or premenopausal and practicing a method of birth control until at least 1 month after the last dose of study drug.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease within the past 6 months that in the opinion of the investigator would adversely affect her participating in this study.
* History of any clinically significant sensitivity or allergy to any medication or food.
* History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption.

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events
timeFrame: Up to 75 Days
measure: Maximum Observed Plasma Concentration (Cmax) of Venetoclax
timeFrame: Up to 45 Days
measure: Time to Cmax (Tmax) of Venetoclax
timeFrame: Up to 45 Days
measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Venetoclax
timeFrame: Up to 45 Days
measure: AUC From Time 0 to the Time Infinity (AUCinf) of Venetoclax
timeFrame: Up to 45 Days
measure: Apparent Terminal Phase Elimination Rate Constant (β) of Venetoclax
timeFrame: Up to 45 Days
measure: Terminal Phase Elimination Half-life (t1/2) of Venetoclax
timeFrame: Up to 45 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 255783
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03683953: The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells
Official title: The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Safety Issues
Effect of Drugs
Keywords: mesenchymal stem cells
safety
effect
BPD
Lead sponsor: Guangdong Women and Children Hospital
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 200
Sex: ALL
Minimum age (years): 28
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effect and saftey of intratracheal instillation of mesenchymal stem cells for treatment BPD

Detailed description: This is a Phase 1 clinical trial that constitues two points cohorts with 100 participants per cohort who will receive instillation dose of mesenchymal stem cells-25 million cells/kg,with ventilation after 14 days.And the placebol will be 0.9% sodium choride. The investigator will proceed the groups during the same period.

1. Deographic Data and Baseline charateristics of the studied groups were collected:

   Gestational age (weeks) Birth weight (g) gender Cesarean section delivery Antenatal steroids Prolonged rupture of membrane Multiple pregnancies APGAR score at 5 minutes
2. mesenchymal stem cels dose is 25 million cells/kg
3. Assessment the incidence of BPD after instillation of Mesenchymal stem cells
4. the adverse after instillation of Mesenchymal stem cells

Eligibility criteria: Inclusion Criteria:

twenty-eight weeks to thirty-seven weeks prematures who need ventilaton for 14 days after birth, and the oxygen concentration is more than 30%

Exclusion Criteria:

Preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection

Primary outcomes:
measure: number of patients with BPD after instillation mesenchymal stem cells
timeFrame: up to 28 days after birth
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Guangzhou, Guangdong,China，511442
name: Jie Yang, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mezey E, Nemeth K. Mesenchymal stem cells and infectious diseases: Smarter than drugs. Immunol Lett. 2015 Dec;168(2):208-14. doi: 10.1016/j.imlet.2015.05.020. Epub 2015 Jun 4.
Clinical trial NCT06632353: Biomarkers in Dermal Interstitial Fluid for Early Diagnosis and Follow-up of Cardiovascular Diseases
Official title: Biomarkers in Dermal Interstitial Fluid for Early Diagnosis and Follow-up of Cardiovascular Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Lead sponsor: Ascilion AB
Sponsor class: INDUSTRY
First posted: 2024-10-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and subjects recruited at hospital

Brief summary: Sampling of dISF and blood plasma for qualitative measurements.

Detailed description: Sampling of dISF will be performed to investigate biomarkers in dISF for early diagnosis and follow-up of cardiovascular diseases.

Eligibility criteria: Inclusion criteria:

Group 1: Chronic heart failure with stable therapy. NYHA classification III and IV. Age \> 60 years. Group 2: Age 18-40 years.

Exclusion criteria:

* Participating in another clinical investigation which may affect the study outcome according to clinical judgement.
* Previous use of sampling system used.
* Pregnancy or lactating.
* Any disease or condition that may be affected.
* Individuals who lack the ability to fully consent to participate in the study.
* Severe skin injury.
* Tattoo or piercing close to sampling area.
* Group 1: All forms of emergency care.
* Group 1: Non-stable therapy.
* Group 1: Sepsis.
* Group 1: BMI \> 30kg/m2.
* Group 1: Age \> 84 years.
* Group 2: Known heart or vascular disease.
* Group 2: Diabetes.
* Group 2: Kidney disease.

Primary outcomes:
measure: Presence of dISF biomarker
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Danderyd
country: Sweden
facility: Danderyd Hospital
Study officials:
References:
Clinical trial NCT03880253: Multiple Ascending Dose Study of CTP-692 in Healthy Volunteers
Official title: A Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of CTP-692 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess in healthy male and female subjects the safety and pharmacokinetic (PK) profiles of 3 dose levels of CTP-692 following 7 days of dosing.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males and females between 18 and 55 years of age, inclusive
* Body weight ≥ 55 kg and body mass index within the range of 18 to 32 kg/m2, inclusive

Exclusion Criteria:

* Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/or prior to the first dose of study drug
* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen or hepatitis C virus antibody
* History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions
* Positive drug or alcohol test at screening or prior to the first dose of study drug

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety
timeFrame: Assessments done Day 1 - 9
measure: Measurement of CTP-692 exposure in plasma
timeFrame: Assessments done Day 1 - 9
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
Study officials:
References:
Clinical trial NCT00881153: To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.
Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz GmbH and Bristol-Myers Squibb Company (Cefzil) 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose In Healthy Adults Volunteers Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Antibiotic
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 20
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: The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MDS Pharma Services
name: Magdy L. Shenouda, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05657353: Relation Between Bruxism and Cervical Function
Official title: Correlation Between Bruxism And Cervical Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bruxism
Keywords: Bruxism
cervical pain
cervical proprioception
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Observational Cohort Study

Brief summary: correlation between Bruxism and Cervical function

Detailed description: Bruxism is defined as an unconscious oral habit of dysfunctional rhythmic pressing, clenching and grinding of the teeth when performing movements that are not part of the masticatory function that leads to occlusal trauma and it is an oral parafunctional activity it is not related to normal physiological functions, such as speech, breathing, chewing and swallowing , and/or by bracing or thrusting of the mandible , and it accelerates abnormal tooth wear, periodontal disease, and temporomandibular disorders (TMD)

Bruxism should be considered a potential protective risk factor rather than a disorder in otherwise healthy individuals. In most persons bruxism is not a disorder, it is a sign of a disorder (e.g. in individuals with obstructive sleep apnea, epilepsy , being the ending episode of respiratory arousals, so as to prevent the collapse or restore the patency of the upper airway whilst asleep) , which would classify bruxism as an attribute that decreases the chance of a negative health outcome.

There is two distinct circadian manifestations, either occurring during wakefulness or during sleep. Awake bruxism is a semivoluntary masticatory muscle activity during wakefulness that is characterized clenching or grinding tooth and/or by bracing or thrusting of the mandible

Eligibility criteria: Inclusion Criteria:

* Tooth-grinding or clenching .
* Sounds associated with bruxism or jaw muscle discomfort.
* Pain in the jaw, temple, ear or front of the ear and pain modified by jaw movement, function, or parafunction.

Exclusion Criteria:

* History of trauma to the face .
* History of orthodontic treatment, craniofacial anomalies, degenerative disease, or TMJ trauma .
* Any systematic joint or muscle disease and neurologic disorder. neurologic disorders (eg, trigeminal neuralgi ,neurologic disorders (eg, trigeminal neuralgi neurologic disorders (eg, trigeminal neuralgi
* Osteoarthrosis or arthritis of temporomandibular joint .
* Tumors in the head and neck area.

Primary outcomes:
measure: Pressure Algometer
timeFrame: 4 months
Secondary outcomes:
measure: Bubble Incliniometer
timeFrame: 4 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: IPC clinic
Study officials:
affiliation: university
name: Rania karkousha, Assis.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05870553: A Phase 3 Trial in Bowel Preparation for Colonoscopy
Official title: A Prospective, Randomized, Single-blinded (Evaluator), Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bowel Preparation
Lead sponsor: Taejoon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-23
Enrollment: 137
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Male and female outpatients and inpatients aged: ≥19
* A prospective colonoscopy person
* Written informed consent to participate in the trial

Exclusion Criteria:

* Patients with past history of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
* Patients with ongoing severe acute Inflammatory Bowel Disease.
* Patients who have had previous significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection, defunctioning colostomy.
* Pregnant women or pregnant women or pregnant women
* Severe heart disease (cardiac failure (NYHA class 3 and 4))
* Acute coronary artery disease within 24 weeks before screening (an unstable angina pectoris, acute myocardial infarction), clinically significant arrhythmia, hypertrophic obstruction Cardiomyopathy, valvular disease, aortic and peripheral vascular diseases.
* People who have hypersensitivity or allergies to clinical trial drug components.

Primary outcomes:
measure: Number of Patients With Successful Bowel Cleansing (Overall Colon)
timeFrame: 1 day of scheduled colonoscopy
Secondary outcomes:
measure: Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
timeFrame: 1 day of scheduled colonoscopy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Taejoon Pharmaceutical Co., Ltd.
Study officials:
References:
Clinical trial NCT02806453: Effect of Magnesium Alginate on Gastroesophageal Reflux in Infants.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gastroesophageal Reflux
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 99
Sex: ALL
Minimum age (years): 3
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized controlled cross-over trial in full-term infants affected by symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised).

The parents of all of the enrolled infants will be reassured on the benign nature of the condition and will advise to apply lifestyle changes for one week.

Than, the patients will be randomized into one of the two sequence treatment groups. (group A: Mg alginate/thickened formula; group B: thickened formula/Mg alginate) for two weeks. Evaluation of symptom scores will be performed at day 0, day 7, day 21 and day 35.


Eligibility criteria: Inclusion Criteria:

* full-term ages 3 to 12 months, affected by symptoms suggestive of GER.
* infant regurgitation defined according to the Rome IV criteria
* informed consent

Exclusion Criteria:

* Evidence of chronic diseases, hepatic, renal, or cardiac diseases, metabolic or central nervous system diseases, or use of acid suppressor treatment (H2-receptor antagonists or proton pump inhibitors \[PPIs\]), thickened formula, or a history of prematurity or atopy

Primary outcomes:
measure: Evaluation of symptom scores
timeFrame: From day 0 to day 35
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Study officials:
References:
Clinical trial NCT00862953: Study to Assess the Effects of High Protein Diet in Obesity, the LOWER Study
Official title: The Lifestyle, OverWeight, Energy Restriction Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: low carbohydrate
high protein diet
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2009-03-17
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This program is carried out in a dedicated outpatient-clinic in the city of Hengelo for the evaluation and treatment of subjects with obesity. The program puts emphasis on intervention with appropriate diet and physical exercise, and supports the patients in achieving long-term behaviour changes. Interventions which are compared are normal vs high protein/low carb diets.

Detailed description: Assessment focuses on the effect of the specific diets on weight reduction after 3 months, and weight maintenance after 12 months.

Eligibility criteria: Inclusion Criteria:

* Obesity with BMI \> 27 kg/m2

Exclusion Criteria:

* Recent loss of body weight (\>10%)
* Underlying malignancy, HIV infection, psychiatric disease
* Pregnancy or breast feeding

Primary outcomes:
measure: Body weight
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hengelo
country: Netherlands
facility: Hospital Hengelo
Study officials:
affiliation: Previtas Hengelo
name: F NR Van Berkum, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01627353: Post Hysterectomy Pain Prevention: Pre-op Wound Infiltration With Anesthetic Protocol Versus Standard of Care
Official title: Post Hysterectomy Pain Prevention: Randomized Clinical Trial of High Volume Preoperative Wound Infiltration and Pain Specific Anesthetic Protocol Versus Standard of Care (no Wound Infiltration and Routine Anesthetic Protocol)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hysterectomy
Keywords: Hysterectomy
Pain Prevention
Wound Infiltration
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2012-06-25
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a blinded randomized clinical trial, comparing policies of high volume preemptive wound infiltration with a specific anesthetic cocktail versus standard of care (no wound infiltration and routine anesthesia) for post operative pain management after hysterectomy. Morphine use and pain will be measured during index admission, and pain will also be measured six weeks postoperatively. The study will be conducted at a single site, Rockyview General Hospital.


Eligibility criteria: Inclusion Criteria:

* women may be included if they require total abdominal hysterectomies (+/- BSO) at Rockyview hospital.

Exclusion Criteria:

* have endometrial cancer,
* require a vertical midline incision,
* have any additional surgery planned
* have a contraindication to morphine, Magnesium Sulfate, Dexmethasone, Lidocaine or Marcaine
* have difficulty communicating in English

Primary outcomes:
measure: Post Operative Morphine
timeFrame: For the entire post-operative hospital admission (3 days on average)
Secondary outcomes:
measure: Pain measurement using Visual Analogue Scale (VAS) post operatively
timeFrame: Daily until discharge (3 days on average)
measure: Time in recovery (hours)
timeFrame: Until discharge from recovery (on average 2 hours)
measure: Morphine use in recovery
timeFrame: Until discharge from recovery (on average 2 hours)
measure: Adverse events as a result of morphine overdosage
timeFrame: Until discharge from recovery (on average 2 hours)
measure: Change in pain score
timeFrame: baseline - 6 weeks post-operative
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Rockyview General Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Wynne Leung
role: PRINCIPAL_INVESTIGATOR
References: