louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03378284: A Study to Evaluate Safety, Tolerability, and PD of Tegoprazan on Healthy Male Volunteers
Official title: A Randomized, Open-label, Active-controlled, Multiple Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, and Pharmacodynamics of Tegoprazan After Oral Administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacodynamics
Healthy Male Volunteers
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2017-12-19
Enrollment: 16
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A randomized, open-label, active-controlled, multiple dose phase 1 clinical trial to evaluate safety, tolerability, and pharmacodynamics of tegoprazan after oral administration in healthy male volunteers

Detailed description: * To compare the pharmacodynamics of multiple oral dose of tegoprazan versus the pharmacodynamics of multiple oral dose of comparator drug in healthy male volunteers.
* To evaluate the safety and tolerability of multiple oral dose of tegoprazan in healthy male volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy adult males aged ≥ 19 years and ≤ 50 years
* Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening

Exclusion Criteria:

* Presence or history of clinically significant diseases
* Presence or history of gastrointestinal disorder (gastric ulcer, GERD, Crohn's disease, etc.)
* Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
* Serologic test positive
* Abnormal obstacle to insertion and maintenance of pH meter catheter
* History of drug abuse
* Excessive caffeine intake or persistent alcohol intake
* Not use of a medically acceptable method of contraception

Primary outcomes:
measure: Gastric pH
timeFrame: up to 7 days
measure: Serum gastrin concentration
timeFrame: up to 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: In Jin Jang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00783484: A Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539 In Healthy Adult Subjects
Official title: A Double-Blind (3rd Party Open), Placebo-Controlled, Crossover, Dose Escalating Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539, To Assess The Potential Of PF-03716539 To Inhibit CYP3A4 (In Vivo) And To Evaluate The Drug Interaction Potential Between PF-03716539 And Darunavir Or Maraviroc In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: First in Human (FIH), PF-03716539, PK enhancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 37
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: First in human study to evaluate the safety, tolerability, and pharmacokinetics of PF-03716539. The potential of PF-03716539 to increase the concentrations of midazolam, darunavir and maraviroc will also be evaluated.


Eligibility criteria: Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.

Body Mass Index (BMI) of approximately 18 to 30 kg/m2. Total body weight \>50 kg (110 lbs).

Exclusion Criteria:

Pregnant or nursing females. females of childbearing potential. Evidence or history of clinically significant hematological, renal (including kidney stones), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or clinical findings at screening.

Treatment with an investigational drug within 30 days (or determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.

Primary outcomes:
measure: To evaluate the safety and tolerability of escalating single oral doses of PF 03716539 administered as Extemporaneous Powder for Solution (EPS) in healthy adult subjects.
timeFrame: 27 days
measure: To explore the pharmacokinetics of escalating single oral doses of PF 03716539 in healthy adult subjects.
timeFrame: 6 days
Secondary outcomes:
measure: To assess the potency of PF 03716539 for CYP3A4 inhibition utilizing single dose IV midazolam as a probe substrate for CYP3A4/5.
timeFrame: 6 days
measure: To evaluate the potential of PF 03716539 to enhance or "boost" the pharmacokinetics of both darunavir and maraviroc.
timeFrame: 8 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02287584: Confirmatory Study of DSP-5423P in Patients With Schizophrenia
Official title: Confirmatory Study of DSP-5423P in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Sumitomo Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-11-10
Enrollment: 580
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: The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with placebo in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Patients who have schizophrenia diagnosed by DSM-5, diagnostic criteria
* Patients who are aged 18 years or older at informed consent
* Patient understands the objectives and procedures of the study and who provide written voluntarily consent to participate in the study, etc.

Exclusion Criteria:

* Patients who fall under a contraindication listed in the blonanserin (LONASEN) package insert
* Patients with Parkinson disease
* Patients who previously received blonanserin, etc.

Primary outcomes:
measure: Change in PANSS Total Score From Baseline at Week 6
timeFrame: Week 6
Secondary outcomes:
measure: Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
timeFrame: Week 6 (LOCF)
measure: Treatment Continuation Rate at 28 Weeks and 52 Weeks
timeFrame: Open-Week 28 and Open-Week 52 in the open-label treatment phase
Other outcomes:
Locations:
city: Beijing, Etc.
country: China
facility: 3 Sites
city: Tokyo Etc.
country: Japan
facility: 53 Sites
city: Seoul, Etc.
country: Korea, Republic of
facility: 7 Sites
city: Kuala Lumpur, Etc.
country: Malaysia
facility: 14 Sites
city: Manila, etc.
country: Philippines
facility: 9 Sites
city: Smolensk, Etc
country: Russian Federation
facility: 8 Sites
city: Taipei, Etc.
country: Taiwan
facility: 6 Sites
city: Poltava, Etc
country: Ukraine
facility: 8 Sites
Study officials:
affiliation: Sumitomo Pharma Co., Ltd.
name: Director, Drug Development Division
role: STUDY_DIRECTOR
References:
Clinical trial NCT00171184: Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder
Official title: Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: Overactive bladder, Darifenacin, M3 muscarinic receptor antagonist, elderly population
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Procter and Gamble
First posted: 2005-09-15
Enrollment: 400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the efficacy, safety and tolerability of 12-weeks treatment with darifenacin in patients aged \>Ý 65 years with OAB.


Eligibility criteria: Inclusion Criteria:

* Symptoms of OAB for at least six months prior to Visit 3
* Symptoms of OAB during the 7 day diary period immediately preceding Visit 3:
* ≥ 1 UUIE on average per day and
* ≥ 10 episodes of micturition on average per day

Exclusion Criteria:

* A total daily urinary volume \> 3000 ml or a mean volume voided per micturition of \> 300 ml as verified in the micturition diary before randomization
* Post-void residual (PVR) urinary volume \> 100 ml
* Clinically significant stress urinary incontinence as determined by the investigator
* Clinically significant bladder outlet obstruction as determined by the investigator
* Concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh B and C), severe ulcerative colitis, toxic megacolon.

Other protocol inclusion / exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in number of urge urinary incontinence episodes (UUIE) per week at week 12.
Secondary outcomes:
measure: Change from baseline in : number of UUIE per week at week 1, 2 and 6, number of micturitions per day at week 1,2 and 12; number of urinary incontinence pads used per week at week 1,2,6 & 12; number of nocturnal voids per week at week 1,2,6 & 12.
measure: Safety and tolerability.
measure: Quality of life at week 6 and/or 12.
Other outcomes:
Locations:
city: Houston
country: United States
facility: Scott Department of Urology Baylor College of Medicine
state: Texas
Study officials:
affiliation: East Hanover NJ
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT06117384: Systems Oncology Approach to Optimize Ovarian Cancer Treatment
Official title: Systems Oncology Approach to Optimize Ovarian Cancer Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
First posted: 2023-11-07
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All ovarian cancer patients who give their informed consent to the study.

Brief summary: The overall aim is to identify effective therapeutic strategies to ovarian cancer (OC) using serial tumor, ascites and blood samples, and carry out state-of-the-art sequencing approaches, functional assays and associated bioinformatics to understand mechanisms behind chemoresistance in OC and identify new treatment options for OC patients. In this observational trial, we will systematically collect, analyze and interpret functional, molecular and clinical data from real-world ovarian cancer patients.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with ovarian cancer
* Available tumor tissue/blood samples

Exclusion Criteria:

* Inability to consent to the study

Primary outcomes:
measure: Recruitment and collection of real-world clinical data from ovarian cancer patients
timeFrame: 5 years
measure: Successful collection and translational analysis of biospecimens
timeFrame: 5 years
Secondary outcomes:
measure: Discovery of candidate prognostic and predictive biomarkers
timeFrame: 5 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University and Helsinki University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Anniina Färkkilä, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03751384: Improvement of Compliance for High Doses of EPA Amongst Patients With Colorectal Cancer
Official title: Fish Oil Supplementation in Cancer Patients - Capsules or in Nutritional Supplements. A Controlled Trial of Compliance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compliance
Abdominal Cancer
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2018-11-23
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation, not randomized
Primary purpose: SUPPORTIVE_CARE

Brief summary: Several studies indicate beneficial effects of eicosapentanoic acid (EPA) on cancer cachexia. However, compliance is generally low. This case control study is conducted in order to investigate if compliance depends upon the physical properties of the supplement (capsules vs. drinks). In order to further investigate how compliance can be improved, a possible correlation between sideeffects and rate of increased polyunsaturated fatty acid concentration in blood is also tested

Detailed description: Patients with abdominal cancer in active chemotherapeutic were allocated to either EPA in an oral nutritional drink (commercial) or capsules with fish oil. The dose of EPA was the same in both groups, and diets were adjusted as iso-caloric. Compliance to the fish oil treatment was the primary outcome. Blood concentrations of EPA secondary.

Eligibility criteria: Inclusion Criteria:

* Patients receiving chemotherapy on Rigshospitalet due to colorectal cancer
* Not terminally ill
* Subjects must be18 years of age (or older)

Exclusion Criteria:

* Subjects who do not read/speak/understand Danish
* Familial hypercholesterolemia
* Predialytic patients (GFR \< 15 ml/min/1,73 m2 or creatinine ≥ 500 mmol/L)
* Use of blood thinners
* Bleeder's disease

Primary outcomes:
measure: Compliance
timeFrame: 4 weeks
Secondary outcomes:
measure: Erythrocyte concentration of EPA
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: University of Copenhagen
name: Jens R Andersen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt N, Moller G, Baeksgaard L, Osterlind K, Stark KD, Lauritzen L, Andersen JR. Fish oil supplementation in cancer patients. Capsules or nutritional drink supplements? A controlled study of compliance. Clin Nutr ESPEN. 2020 Feb;35:63-68. doi: 10.1016/j.clnesp.2019.12.004. Epub 2020 Jan 3.
Clinical trial NCT03041584: Dental Implants Placed by Using a Drill Guide Versus Non-guided Placement. Follow-up Study
Official title: Implant-centered Outcomes of Guided Surgery, a 3-year Follow-up: An RCT Comparing Guided Surgery With Non-guided Implant Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Failure Nos
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Dentsply Sirona Implants and Consumables
First posted: 2017-02-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess implant outcomes, both clinical and radiological, in a randomized study on guided implant placement after 3-year follow-up, compared to non-guided treatment.


Eligibility criteria: Inclusion Criteria:

1. Provision of informed consent
2. An age of at least 18 year
3. Extraction socket healing for at least 6 months

Exclusion Criteria:

1. Unlikely to be able to comply with study procedures
2. History of intravenous bisphosphonate treatment
3. Medical history that makes implant insertion unfavorable
4. Current pregnancy
5. Present alcohol and/or drug abuse
6. Major systemic diseases
7. Untreated, uncontrolled caries and/or periodontal disease
8. History of local irradiation
9. Need for bone grafting and/or sinus lift in the planned implant area

Primary outcomes:
measure: Radiographic outcome
timeFrame: Change between baseline and 3 Year
Secondary outcomes:
measure: probing pocket depth
timeFrame: Change between baseline and 3 Year
measure: bleeding on probing
timeFrame: Change between baseline and 3 Year
measure: plaque
timeFrame: Change between baseline and 3 Year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05260502: The Relationship Between Brain Volume and Sensory Integration in Autistic and Attention Deficit Hyperactivity Disorder.
Official title: The Relationship Between Brain Volume and Sensory Integration in Children and Adolescence With Attention Deficit Hyperactivity Disorder and Autistic Spectrum Disorder.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sensory Integration Dysfunction
Keywords: sensory disintegration
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 105
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Both males and females were included. Age ranges from 6- 18 years.

Brief summary: The relationship between brain volume and sensory integration in children and adolescence with attention deficit hyperactivity disorder and autistic spectrum disorder; comparative study

Detailed description: Detect pattern of sensory disintegration in autistic and attention deficit hyperactivity disorder children and adolescence. Also detect relationship between changes in brain and sensory disintegration in each group.

Eligibility criteria: Inclusion Criteria .Diagnosis of Autism spectrum disorders /ADHD verified and confirmed on a clinical basis.

. Willing of the parents or the caregivers to participate in the study.

Exclusion Criteria:

.Children with intelligence quotient below 70. .Children with history or current substance use. .Children with medical or other neurological conditions. .Children with history of preterm labour (as brain volume lower than term delivery).

-

Primary outcomes:
measure: sensory disintegration in neurodevelopmental disorders
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gourley L, Wind C, Henninger EM, Chinitz S. Sensory Processing Difficulties, Behavioral Problems, and Parental Stress in a Clinical Population of Young Children. J Child Fam Stud. 2013 Oct 1;22(7):912-921. doi: 10.1007/s10826-012-9650-9.
citation: Al-Heizan MO, AlAbdulwahab SS, Kachanathu SJ, Natho M. Sensory processing dysfunction among Saudi children with and without autism. J Phys Ther Sci. 2015 May;27(5):1313-6. doi: 10.1589/jpts.27.1313. Epub 2015 May 26.
citation: Schaaf RC, Lane AE. Toward a Best-Practice Protocol for Assessment of Sensory Features in ASD. J Autism Dev Disord. 2015 May;45(5):1380-95. doi: 10.1007/s10803-014-2299-z.
Clinical trial NCT06266702: Evaluation of a Nutritional Technology for Vitamin D Absorption
Official title: Evaluation of a Lipid-based Nutritional Technology for Enhancing Vitamin D Absorption in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition, Healthy
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a prospective, 2-group crossover, randomized, double-blind study to evaluate nutrient absorption.


Eligibility criteria: Inclusion Criteria:

* Adult participants (18-55 years of age)
* Body mass index (BMI) \<30 kg/m2
* Males and nonpregnant, nonlactating females
* Free of gastrointestinal disorders that my impact nutrient absorption in the small intestine, endocrine, hepatic, renal, or bone diseases

Exclusion Criteria:

* Use of vitamin D or calcium supplements within 3 weeks prior to the Screening Visit.
* Use of a tanning booth/lamp within 3 weeks prior to the Screening Visit.
* Travel to sunny location within 3 weeks prior to the Screening Visit.
* Consumption of more than 3 alcoholic drinks per day starting 48 hours before the Screening Visit.
* Has an allergy or intolerance to any ingredient in the study product.
* Participating in another study that has not been approved as a concomitant study by Abbott Nutrition.
* Use of the following medications that may have interactions with vitamin D absorption or metabolism:

  * Aluminum-containing phosphate binders
  * Anticonvulsants
  * Atorvastatin
  * Calcipotriene
  * Cholestyramine
  * Cytochrome P-450 3A4 substrates
  * Digoxin
  * Diltiazem
  * Orlistat
  * Thiazide diuretics
  * Corticosteroids
  * Stimulant laxatives
  * Verapamil

Primary outcomes:
measure: Vitamin D Absorption
timeFrame: Time 0 to 24 Hours
Secondary outcomes:
measure: Vitamin D Absorption - Peak
timeFrame: Time 0 to 48 Hours
measure: Vitamin D Absorption - AUC
timeFrame: Time 0 to 48 Hours
Other outcomes:
measure: Body Mass Index
timeFrame: Visit 1, Baseline Collection
measure: Adverse Events
timeFrame: Study Day 1 to Study Day 7 up to 20 Days
Locations:
city: North Canton
country: United States
facility: Walsh University
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: Steve Hertzler
role: STUDY_CHAIR
References: