louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03212586: BAY 1902607: Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Bioavailability, Food Effect
Official title: Randomized, Placebo-controlled, Double-blind, Parallel-group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of BAY1902607 Including the Relative Bioavailability Between Different Pharmaceutical Formulations and the Effect of Food on the Pharmacokinetics of BAY1902607 in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clinical Trials, Phase I as Topic
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-07-11
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is a first-in-man study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1902607 using a placebo controlled, randomized, single center design. In addition the influence of food on the pharmacokinetics of BAY1902607 and the bioavailability between different pharmaceutical formulations will be investigated


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects.
* Age: 18 to 45 years (inclusive) .
* Body mass index (BMI) : ≥18 and ≤30 kg/m\^2.
* Race: White.

Exclusion Criteria:

* Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed by the investigator to be of clinical relevance.
* Relevant diseases within the 4 weeks before the first drug administration.
* Febrile illness within the week before the first taste test is conducted.

Primary outcomes:
measure: Number of subjects with treatment-emergent adverse events
timeFrame: Up to 11 weeks
measure: Number of subjects with severity of treatment-emergent adverse events
timeFrame: Up to 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: CRS Clinical Research Services Berlin GmbH
Study officials:
References:
Clinical trial NCT04356586: Immune Response to Covid-19 in 300 Health Care Workers With Mild Symptoms
Official title: Immune Response to Covid-19 in 300 Health Care Workers With Mild Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Serology
Lead sponsor: Sciensano
Sponsor class: OTHER_GOV
Collaborators: name: Jessa Hospital
First posted: 2020-04-22
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HCW previous tested for Covid-19 with mild symptoms in Jessa Ziekenhuis, Belgium

Brief summary: Three hundred healthcare workers with mild symptoms for Covid-19 will be followed during three months. Each two weeks, serological tests will be performed. Re-infection will be monitored by saliva-swabs.


Eligibility criteria: Inclusion Criteria:

* HCW previous tested for Covid-19 with mild symptoms in Jessa Ziekenhuis, Belgium

Exclusion Criteria:

-

Primary outcomes:
measure: Percentage of serological positive healthcare workers
timeFrame: three months
measure: Percentage of HCW with positive Saliva-sabs
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Sciensano
Study officials:
affiliation: Sciensano
name: Maria Goossens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05461586: Clinical Investigation of Refraction Techniques
Official title: Clinical Investigation of Refraction Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Error
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participant in PCOL-102-AHSF who were bilaterally implanted with TECNIS IOL, Models C1V000, C2V000 or ICB00 and have completed and are at least 30 days postoperative from their second eye surgery.

Brief summary: Prospective, multi-center, non-interventional, randomized, comparative clinical study to identify an optimal refractive technique that provides maximum plus refractive endpoint for best corrected distance visual acuity (BCDVA).


Eligibility criteria: Inclusion Criteria:

1. Participant in PCOL-102-AHSF who were bilaterally implanted with TECNIS IOL, Models C1V000, C2V000 or ICB00 and have completed and are at least 30 days postoperative from their second eye surgery;
2. At least one implanted eye with clear ocular media;
3. Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in Australia and New Zealand;
4. Availability, willingness and sufficient cognitive awareness to comply with examination procedures.

Exclusion Criteria:

1. Best-corrected distance visual acuity (BCDVA) worse than 0.66 decimal (6/9 or 20/30 Snellen);
2. Subjects with ongoing adverse events that might impact outcomes during the study visit as determined by the investigator.

Primary outcomes:
measure: Difference between two manifest refractive techniques on outcome variable MRSE
timeFrame: Day 0
measure: Difference between two manifest refractive techniques on visual acuity
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Birtinya
country: Australia
facility: Sunshine Eye Clinic
state: Queensland
Study officials:
affiliation: Johnson & Johnson Surgical Vision, Inc.
name: Johnson & Johnson Surgical Vision, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT02190786: Phase II Exploratory Clinical Study of KUX-1151
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperuricemia
Keywords: Hyperuricemia
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-07-15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of multiple oral administration of KUX-1151 in patients with hyperuricemia including gout.


Eligibility criteria: Inclusion Criteria:

* Japanese HU patients (Outpatient)
* Patients who meet the following criteria concerning serum uric acid levels at the screening \[1) Gout: \> 7.0 mg/dL, 2) HU with complications: ≥ 8.0 mg/dL, 3) HU without complications: ≥ 9.0 mg/dL\]

Exclusion Criteria:

* Patients who have any symptom of gouty arthritis within 2 weeks of investigational product administration

Primary outcomes:
measure: Proportion of subjects achieving serum uric acid level ≤ 6 mg/dL
timeFrame: 14 weeks
measure: Percent change from baseline in serum uric acid level
timeFrame: 14 weeks
measure: Change from baseline in serum uric acid level
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo and Other Japanese City
country: Japan
Study officials:
References:
Clinical trial NCT01071486: Busulfan Pharmacokinetic Analysis and GST Polymorphism in Adults Undergoing Hematological Stem Cell Transplantation
Official title: Busulfan Pharmacokinetic Analysis and Glutathione S-transferase (GST)Genetic Polymorphism (A1,T1,M1,P1)in Adults Undergoing Hematological Bone Marrow Transplantation (HSCT).
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Busulfan Pharmacokinetic Analysis
GST Genetic Polymorphism
Keywords: Busulfan
Glutathione S-transferase
Genetic polymorphism
HVOD
GVHD
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Israel Cancer Association
First posted: 2010-02-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Between 100 up to 200 adults undergoing HSCT for their primary disease will be included in this pharmacokinetic/pharmacogenetic study. In the preparative protocol Busulfan (BU)will be included as indicated in a known protocol. The GST polymorphism (A1,M1,T1 and P1) will be investigated using real time PCR. A correlation between pharmacokinetic parameters and patients polymorphism will be performed using known statistical technics for comparison. The aims of this study are, to correlate the demographic data, clinical presentation, clinical outcomes of the included individuals, the BU kinetics and the GST polymorphism and to establish an outcome "map" for those who receive HSCT for their primary disease.


Eligibility criteria: Inclusion Criteria:

* Malignant or Benign Diseases who need hematological stem cell transplantation as part of their treatment
* Busulfan should be part of the preparative protocol

Exclusion Criteria:

* Known sensitivity or allergy to Busulfan

Primary outcomes:
measure: Hepatic Veno-Occlusive Disease, Graft versus host disease
timeFrame: every week after HSCT up to 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
References:
Clinical trial NCT00635986: Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl
Official title: Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fentanyl Analgesia
Keywords: Analgesia
Fentanyl
Orthopedic
Mechanism of action
Surgery
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: CONTEXT AND OBJECTIVE: Controversies exist regarding the site of action of Fentanyl after epidural injection. The objective of this investigation was to compare the analgesic effect of epidural and intravenous Fentanyl for lower limb orthopedic surgeries.

DESIGN AND SETTING: A randomized and double-blind study was performed in Hospital São Paulo.

METHODS: 29 patients were divided into two groups. During the postoperative period, in the presence of pain, group 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n = 15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl intravenously. Analgesic supplementation consisted of 40 mg intravenous Tenoxicam and 5 mL epidural 0.25% bupivacaine (if pain relief was not achieved with Tenoxicam). Pain intensity was evaluated by numerical scale and plasma concentrations of Fentanyl were measured simultaneously.


Eligibility criteria: Inclusion Criteria:

* Both genders ranging in age from 18 to 65 years, American Society of Anesthesiologists (ASA) Physical Status 1 or 2, scheduled for orthopedic bone surgery of the lower limbs

Exclusion Criteria:

* Patients with infection in the puncture area and coagulation disorders, pregnant patients, and patients using opioids

Primary outcomes:
measure: Pain relief
timeFrame: 1 year
Secondary outcomes:
measure: fentanyl plasma concentration measure in different times
timeFrame: 1year
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Adriana M Issy, PhD
role: STUDY_CHAIR
References:
citation: Privado MS, Issy AM, Lanchote VL, Garcia JB, Sakata RK. Epidural versus intravenous fentanyl for postoperative analgesia following orthopedic surgery: randomized controlled trial. Sao Paulo Med J. 2010 Jan;128(1):5-9. doi: 10.1590/s1516-31802010000100002.
Clinical trial NCT03937986: Suvorexant and Cocaine
Official title: Influence of Orexin Antagonism on Motivation for Cocaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cocaine Use Disorder
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-05-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The research proposed here will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for cocaine, as well as other cocaine-associated maladaptive behaviors in active cocaine users. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of cocaine in humans. As such the outcomes will contribute to our understanding of the clinical neurobiology of cocaine use disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on cocaine addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans.


Eligibility criteria: Inclusion Criteria:

* Recent cocaine use

Exclusion Criteria:

* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
* Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
* Females not currently using effective birth control
* Contraindications to cocaine, methylphenidate or duloxetine

Primary outcomes:
measure: Reinforcing Effects of Cocaine
timeFrame: 12 times over approximately 1 month inpatient admission.
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: William W Stoops, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00652886: Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions
Official title: Compare the Relative Bioavailability of Oxandrolone 10mg Tablets With That of OXANDRIN 10 mg Tablets Following a Single Oral Dose(1*10 mg Tablet) in Healthy, Adult Subjects Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: To Determine the Bioequivalence Under Fasting Conditions
Keywords: Bioequivalence, Oxandrolone,fasting
Lead sponsor: Par Pharmaceutical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cetero Research, San Antonio
First posted: 2008-04-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: -To compare the single dose bioavailability of Kali and BTG

Detailed description: -To compare the bioavailability of Oxandrolone 10mg tablets with that of OXANDRIN 10mg tablets following a single -dose in healthy, adult subjects under fasting conditions.

Eligibility criteria: Inclusion Criteria:

* Healthy subject at least 18 years of age, may be male or they may be female who are unable to bear children.
* Each subject shall be given a general physical examination within 28days of the initiation study.
* At the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements.
* Each female subject will be given a serum test as part of the pregnancy study screening process.
* Clinical laboratory measurements will include Hematology, Clinical Chemistry, Urine Analysis, HIV Screen,hepatitis-B, C screen and Drugs of abuse Screen

Exclusion Criteria:

* Subjects with a history of alcoholism or drug addiction(during past 2 years), or serious gastrointestinal, renal hepatic or cardiovascular disease, tuberculosis, epilepsy. asthma, diabetes, psychosis or glaucoma will not be eligible for thsi study.
* Subjects with any history of breast or prostate cancer will not be eligible to participate in this study.
* Subjects who have a history of allergic response to the class of drug being tested will be excluded from the study.
* Subjects found to have urine/saliva concentration of any of the tested drugs will not be allowed to participate.
* Subjects who have taken any investigational drug within thirty days prior to the first dosing of the study will not be allowed to participate.
* Female subjects who are not able to bear children will not be allowed to participate.
* Female subjects with positive or inconclusive results will be withdrawn from the study.

Primary outcomes:
measure: Rate and Extend of Absorption
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: St.Charles
country: United States
facility: Gateway Medical Research, Inc
state: Missouri
Study officials:
affiliation: Cetero Research, San Antonio
name: Steve Herrmann
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04395586: Clinical Presentations, Microbiology, Antibiotic Resistance Patterns and Management Outcomes of Culture-proven Infection Among Adolescent and Adult in A Tertiary Hospital in Saudi Arabia
Official title: Clinical Presentations, Microbiology, Antibiotic Resistance Patterns and Management Outcomes of Culture-proven Infection Among Adolescent and Adult in A Tertiary Hospital in Saudi Arabia
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Culture-proven Infection
Lead sponsor: Aseer Central Hospital
Sponsor class: OTHER_GOV
First posted: 2020-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any individual aged ≥13 year old requested for him/her bacterial/fungal culture.

Brief summary: The characteristics of patients as well as microbiologic profile of culture-proven infection will be studies in conjunction with clinical outcome within 28-days


Eligibility criteria: Inclusion Criteria:

* Any individual aged ≥13 year old requested for him/her bacterial/fungal culture.
* Able to provide a written informed consent.

Exclusion Criteria:

* Age \<13 years old.
* Unable/unwilling to provide a written informed consent.

Primary outcomes:
measure: Mortality
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Aseer Central Hospital
name: Abdullah M Algarni, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04503486: Relationship Between Muscle Strength and Quality of Life in ICU Survivors
Official title: Relationship Between Grip and Quadriceps Strength on Quality of Life in ICU Survivors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Muscle Strength
Quadriceps Strength
Grip Strength
Quality of Life
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study includes patients in ICU after a stay of at least 7 days. They are included as soon as they are collaborative.

Brief summary: The aim is to study the impact of muscle strength measured in ICU and after ICU discharge on health-related quality of life measured after hospital discharge.


Eligibility criteria: Inclusion Criteria:

* critically ill patients with an ICU stay of at least 7 days
* collaborative

Exclusion Criteria:

* non collaborative, confusion, coma
* limb paresis or plegia
* patient refusal

Primary outcomes:
measure: health-related quality of life
timeFrame: 1 month after ICU discharge
measure: health-related quality of life
timeFrame: 3 months after ICU discharge
measure: health-related quality of life
timeFrame: 6 months after ICU discharge
measure: health-related quality of life
timeFrame: 1 month after ICU discharge
measure: health-related quality of life
timeFrame: 3 months after ICU discharge
measure: health-related quality of life
timeFrame: 6 months after ICU discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University Hospital of Liège
Study officials:
References:
Clinical trial NCT04228263: Hydroxychloroquine and Unexplained Recurrent Miscarriage
Official title: Hydroxychloroquine for Improvement of Pregnancy Outcome in Unexplained Recurrent Miscarriage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unexplained Recurrent Miscarriage
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 156
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Recurrent miscarriage affects women of childbearing age worldwide. Vascular endothelial dysfunction and immunological impairment are associated with recurrent miscarriage To date, there is no effective or optimal therapeutic approach for these condition. Hydroxychloroquine has endothelial protective action via ant diabetic, lipid lowering, antioxidant effects or direct endothelial protection. Hydroxychloroquine is an antimalarial and immunomodulatory agent. In pregnancy, hydroxychloroquine is prescribed for inflammatory conditions associated with adverse perinatal outcomes such as systemic lupus erythematosus, antiphospholipid syndrome and placental inflammatory lesions such as chronic histiocytic intervillositis, hydroxychloroquine has therapeutic potential to improve placental function in pregnancies associated with heightened inflammation.


Eligibility criteria: Inclusion criteria

1. Women aged between 20- 40 years inclusive. 2. Body Mass Index (BMI) between 18.5 -35 Kg/m2 3. Had at least 2 previous miscarriage before 20 weeks 4. Women willing to conceive. 5. Regular Ovulatory cycles. 6. No anatomical or endocrine cause of recurrent pregnancy loss. 7. Women who have given their informed consent. 8. Negative antibody test for antiphospholipid syndrome (Lupus anticoagulant, Anticardiolipin IgM, IgG, B2glycoprotein) Exclusion criteria

1. Women who are already pregnant.
2. Known contraindication to a treatment by HCQ (retinopathy, hypersensitivity to chloroquine or HCQ, G6PD deficiency, acute intermittent porphyria, chronic liver or kidney insufficiency, extensive cutaneous psoriasis not controlled by local treatment, significant chronic digestive , hematologic disease epilepsy or psychotic disorders.) or known rare disorder of lactose metabolism .
3. Patient already using HCQ
4. Patient not get pregnant after 12 months of HCQ use.

Primary outcomes:
measure: Number of viable fetuses at 20 weeks gestation
timeFrame: 5 months
Secondary outcomes:
measure: Number of patients with miscarriage before 20 weeks
timeFrame: 5 months
measure: Number of pregnancy complications such as ( FGR or preeclampsia, IUFD after 20 week gestation)
timeFrame: 9 months
measure: Number of fetus with Major congenital anmalies
timeFrame: 9 months
measure: Number of Live birth
timeFrame: 9 months
measure: Number of Preterm delivery before 37 week gestation.
timeFrame: 8 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Abdel-rahman Mahmoud Mohammed
Study officials:
References: