louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00997919: A Study of the Safety, Tolerability, Pharmacokinetics, and Bioavailability of IV and SC MABT5102A in Healthy Volunteers
Official title: A Phase I, Single-Dose, Randomized, Parallel-Group, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, and Bioavailability of IV and SC MABT5102A in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase I, single-dose, randomized, parallel-group, open-label study will evaluate the safety, tolerability, and pharmacokinetics of MABT5102A following subcutaneous (SC) and intravenous (IV) administration in healthy volunteers.


Eligibility criteria: Inclusion Criteria

* Male subjects aged 18-50 years and female subjects aged 18-50 years who are not of childbearing potential and who are in good general health at the screening visit
* Body weight between 50 and 100 kg
* For male subjects of reproductive potential, a reliable means of contraception must be used (e.g., abstinence or a condom) for the duration of the study

Exclusion Criteria

* Female subjects with reproductive potential.
* Subjects with evidence of clinically significant neurologic, psychiatric, hepatic, renal, hematologic, pulmonary, respiratory, immunologic system abnormalities, acute infection, or other unstable medical disease
* Subjects with any malignancy (with the exception of completely excised basal cell or squamous cell carcinoma of the skin)
* History of alcohol, drug, or substance abuse within 6 months prior to randomization that, in the judgment of the investigator, may put the subject at risk for being unable to participate fully in the study for the duration of the study
* Past history of seizures, with the exception of childhood febrile seizures
* Clinically significant laboratory or ECG abnormalities
* Hospitalization during the 4 weeks prior to screening

Primary outcomes:
measure: Safety (adverse events, laboratory abnormalities, physical and neurological examination findings, vital signs, electrocardiogram (ECG) results)
timeFrame: Until study discontinuation
Secondary outcomes:
measure: Pharmacokinetic/Pharmacodynamic (area under the concentration-time curve, volume of distribution, clearance [CL] and apparent CL, terminal half-life)
timeFrame: Until study discontinuation
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Robert Paul, Ph.D., M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00405119: A Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine.
Official title: A Randomized, Double-blind, Four Period Cross-over Comparison of the Effect of Two Doses Lavoltidine, Esomeprazole, and Placebo on 24 Hour Gastric pH and Frequency of Heartburn in Symptomatic GERD Subjects Without Esophageal Erosions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroesophageal Reflux Disease
Reflux, Gastroesophageal
Keywords: tolerance
pharmacodynamics
ranitidine
esomeprazole
pharmacokinetics
gastroesophageal reflux disease (GERD)
AH23844
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-29
Enrollment: 92
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Current treatment for gastroesophageal reflux disease (GERD) confirms an unmet need in patients, based on slow onset of action and an inability to provide 24-hour gastric-acid suppression. Clinical data on AH234844 demonstrates a rapid onset of action, high potency, and prolonged duration of effect. The present study endeavors, in part, to compare lavoltidine to two GERD drugs, NEXIUM and ranitidine.

Detailed description: A three-part study in healthy male volunteers to determine the most effective of four different lavoltidine doses on gastric pH and to compare the most effective dose with NEXIUM (esomeprazole) 40mg for the inhibition of gastric-acid secretion and with ranitidine (300mg/day) for the amount of pharmacodynamic tolerance

Eligibility criteria: Inclusion criteria:

* Subject must have a Body Mass Index (BMI) from 19-30 kg/m2
* Subject does not present with abnormal clinical lab findings
* Subject is able to tolerate a nasogastric pH electrode.

Exclusion criteria:

* Subject is Helicobacter-positive on a C13 urea breath test
* Subject has a baseline median 24-hour gastric pH\>3
* For Part B of the study, subjects are CYP 2C19 poor metabolizers.

Primary outcomes:
measure: pH over 24hours
timeFrame: over 24hours
Secondary outcomes:
measure: %24 hours pH>4 Median gastric pH Adverse events
timeFrame: over 24 hours
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Herston
country: Australia
facility: GSK Investigational Site
state: Queensland
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01611519: Early or Late Foley Removal After Thoracotomy
Official title: Optimal Timing of Foley Catheter Removal in Patients Undergoing Thoracic Surgery With Epidural Analgesia: A Randomized, Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Keywords: urinary bladder
urinary catheterization
epidural analgesia
catheters, indwelling
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing thoracic surgery at the Mayo Clinic

Brief summary: Is the early removal of Foley catheter safe in patients undergoing general thoracic surgery with an epidural catheter in place?

Detailed description: We hypothesis that removing the foley catheter within 48 hours after a thoracotomy in patients that have an epidural catheter will result in an increase in the rate of urinary infections and the need for reinsertion of the foley. We have designed a randomized trial to test this hypothesis.

Eligibility criteria: Inclusion Criteria:

* epidural catheter after thoracic surgery
* foley in place

Exclusion Criteria:

* \< 18 years of age
* death in hospital within 30 days of the operation
* length of hospital stay is less than 48 hours
* epidural catheter is removed before the 3rd postoperative day
* patients who have a suprapubic catheter or no bladder
* patients who require a urologist or a urologic technician to insert the Foley catheter at the time of surgery
* patients who were being intermittently catheterized before surgery
* patients with a known urinary tract infection preoperatively
* patients required to keep Foley in since they required close monitoring of urinary output

Primary outcomes:
measure: Need for insertion of catheter after Foley removed.
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary outcomes:
measure: Development of urinary tract infection
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark Allen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
Clinical trial NCT01338519: Database Study on Patients With PCOS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hirsutism
PCOS
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2011-04-19
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Premenopausal women referred with hirsutism or PCOS to Odense University hospital

Brief summary: All newly referred patients with PCOS and hirsutism are listed in a database.

Detailed description: All premenopausal women referred to the outpatient clinic at the Department of Endocrinology from 1997 and onward with the referral diagnoses hirsutism and/or PCOS are included in a clinical database. The patients should fulfill the Rotterdam criteria for PCOS or have clinical/biochemical hyperandrogenemia.

Routine evaluation include medical history, clinical examination, transvaginal ultrasound (US), and fasting blood samples. Cycle history is recorded in all patients using a standard scheme prepared for hirsute patients. Blood tests include androgens, LH, FSH, prolactin, and lipid profile.

OGTT and ACTH are performed in high risk patients

Eligibility criteria: Inclusion Criteria:

* premenopausal
* hirsutism or PCOS

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense Univeristy Hospital
name: Marianne Andersen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03898219: Hematogenous Osteomyelitis in Childhood Can Relapse Dozens of Years in Adulthood
Official title: Hematogenous Osteomyelitis in Childhood Can Relapse Dozens of Years in Adulthood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteomyelitis
Hematogenous Osteomyelitis Relapse
Keywords: Hematogenous osteomyelitis
relapse
adulthood
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (≥ 18 years) who presented a relapse between 2003-2015 of a hematogenous osteomyelitis acquired in childhood.

Brief summary: To our knowledge, few cases of relapse in adulthood are described in the literature except in patients with sickle cell disease and the epidemiological, clinical, laboratory, radiological features and the management of osteomyelitis relapsing in adulthood are not described. The aim of this retrospective multicentric cohort study : in France is to describe the epidemiological, clinical, laboratory, and radiological features and the management of adult patients who experienced a relapse between 2003-2015 of an acute hematogenous osteomyelitis acquired in the childhood (description of characterization of the period between the first episode of osteomyelitis and the second episode, description of signs of relapse and description of treatments used in the relapse). The data are analysed with non-comparative descriptive statistics.


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥ 18 years) who presented a relapse between 2003-2015 of a hematogenous osteomyelitis acquired in childhood.
* the time limit between the 2 episodes must be at least 2 years
* antecedent of osteomyelitis before 16 years

Exclusion Criteria:

* inability to give the information to the patient
* patients opposed to the use of their data

Primary outcomes:
measure: Rate of patients having an osteomyelitis
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Secondary outcomes:
measure: rate of bacteria responsible for infection
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
measure: rate of management with surgery
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
measure: Rate of Treatment Failure
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hopital de la Croix Rousse
Study officials:
References:
Clinical trial NCT02804919: CPAP In-home Assessment NZ
Official title: CPAP In-home Assessment NZ
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2016-06-17
Enrollment: 30
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: Phase 1:The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.

Phase 2: To evaluate the CPAP device with communication functionality with data upload.

Detailed description: Phase 1:Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.

Phase 2: 10 participants from Phase 1 will be recruited to use the device for up to 6 month in-home. Participants will attend 3 study visits at day 0, 7 30. The trial may be extended to 60 days if longer term data is required.

Eligibility criteria: Inclusion Criteria:

* Aged 18 and over
* Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
* Be fluent in spoken and written English

Exclusion Criteria:

* Contraindicated for Positive Airway Pressure (CPAP or AutoCPAP) therapy
* Persons with other significant sleep disorder(s) (e.g periodic leg movements, insomnia, central sleep apnea)
* Persons with obesity hypoventilation syndrome or congestive heart failure
* Persons that require supplemental oxygen with their Positive Airway Pressure (CPAP or AutoCPAP) device.
* Persons with implanted electronic medical devices (e.g cardiac pacemakers)
* Persons who are pregnant or think they may be pregnant.

Primary outcomes:
measure: Apnea Hypopnea Index (AHI), measured as number of events/hour hour.
timeFrame: 6 months
measure: Log of safety-related events, measured as number of safety-related faults
timeFrame: 6 months
measure: Machine reported faults, measured as number of machine faults
timeFrame: 6 months
measure: Participant reported faults, measured as number of participant complaints
timeFrame: 6 months
Secondary outcomes:
measure: Perception of the device, measured through questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher & Paykel Healthcare
Study officials:
affiliation: Fisher & Paykel Healthcare
name: Irene Cheung, MSc/RPSGT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05485519: Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit at King Abdullah Specialist Children Hospital- Ministry of National Guard Health Affairs.
Official title: Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit (PICU) at KASCH-MNGHA.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dexmedetomidine
Midazolam
Withdrawal Symptoms
Failure of Extubation
Keywords: Dexmedetomidine
Midazolam
Intubation
Withdrawal Symptoms
failure of Extubating
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 430
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. Total of 430 patients will participate to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours in pediatric Intensive Care Unite.

Detailed description: Prospective, randomized, open label, controlled study, will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. 340 patients will be randomly randomized to Midazolam (M) or Dexmedetomidine (D), to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours.

Eligibility criteria: Inclusion Criteria:

1. Age 1-14 years both male and female who require mechanical ventilation
2. Informed consent from signed by patient's legal representatives, and for patients aged 12- 14 who has an age-appropriate understanding additional assent form signed by patient is required.
3. Intubated within 6 hours and anticipated to require mechanical ventilation for more than 48 hours

Exclusion Criteria:

1. Septic shock and/or multi-organ failure.
2. Hemodynamically instability and requires inotropes.
3. Severe intracranial or spinal trauma with high intracranial pressure
4. Liver failure
5. Acute or chronic renal failure.
6. Glasgow Coma Scale (GCS) ≤8
7. Known to have allergy to the study drugs
8. Airway surgery

Primary outcomes:
measure: Mean time taken from end of sedation to extubation with no or minimal withdrawal symptoms
timeFrame: from end of sedation to extubation assessed up to 24 hrs
Secondary outcomes:
measure: To compare length of PICU stay in both groups
timeFrame: from Intubation to discharge assessed up to 1 month
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdullah Specialist Children Hospital (KASCH)
Study officials:
References:
Clinical trial NCT01641419: Trial Comparing Duration of Analgesia After Popliteal Fossa Sciatiac Nerve Block With Ropivacaine 0.5% When Combined With Placebo, Dexamethasone 4mg or Dexamethasone 8 mg
Official title: Randomized, Controlled Trial Comparing Duration of Analgesia After Popliteal Fossa Sciatiac Nerve Block With Ropivacaine 0.5% When Combined With Placebo, Dexamethasone 4mg or Dexamethasone 8 mg
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain, Sciatic Block
Keywords: Pain
Ropivacaine
sciatic block
dexamethasone
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2012-07-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose is to find out if the addition of dexamethasone to ropivacaine 0.5% increases the duration of pain relief provided by popliteal sciatic nerve block performed for foot/ankle surgery. The investigators also want to find out if there is a difference between 4 and 8 mg dose of dexamethasone.


Eligibility criteria: Inclusion Criteria:

* Ages 18-64
* ASA Physcial Status classification 1-3
* Foot and ankle surgery at Ben Taub General Hospital

Exclusion Criteria:

* diabetes mellitus
* peripheral neuropathy
* coagulopathy
* allergy to study drugs
* systemic glucocorticoid treatment (for 2 weeks or more) within 6 months of surgery
* chronic opioid use at home
* patient inability to properly describe pain to investigators
* pregancy
* prisoners
* patient or surgeon refusal

Primary outcomes:
measure: Duration of analgesia
timeFrame: 48 hours
Secondary outcomes:
measure: Total pain medication
timeFrame: 24 hours
measure: Pain scores
timeFrame: 24 hours
Other outcomes:
Locations:
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
Study officials:
References:
Clinical trial NCT06210919: Safety and Tolerability of Autologous Adipose-derived Mesenchymal Stem Cells Therapy in Adults With Atrophic Scars
Official title: A Phase 1, Single-Center, Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Single Dose of TRTP-101 in Adults With Atrophic Scars
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Atrophic Scar
Lead sponsor: CellinCells
Sponsor class: INDUSTRY
First posted: 2024-01-18
Enrollment: 3
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial was to evaluate the safety and tolerability for 12 weeks after one dose of TRTP-101 in adults with atrophic scars.

Detailed description: A phase 1 clinical trial to evaluate dose-limiting toxicity by administering a singe dose of TRTP-101 to each of the four sites of atrophic scar.

Eligibility criteria: Inclusion Criteria:

1. Male or Female aged greater than 19 years
2. Four or more atrophic scars in the joints, genitals, perineum, and face except for the lips, eyes and nose

Exclusion Criteria:

1. History of cell therapy
2. Treatment of Dermal resurfacing, Chemical/Mechanical Peel and Skin Photorejuvenation
3. Treatment of Hyaluronic acid/collagen skin filler, non-permanent soft tissue filler and fat grafting
4. Positive for virus infection
5. Use of Anticoagulant therapy or NSAIDs
6. Thrombocytopenia or other coagulation disorder
7. History of keloid scars
8. Infectious disease or other dermatitis in the area of the atrophic scar
9. Use of Immunosuppressant, immunomodulating drug, anticancer drug or radiation therapy
10. Use of systemic steroid medication
11. History of hypersensitivity or severe allergic reactions (e.g., anaphylaxis, Guillain-Barre syndrome, etc.)
12. Use of retinoid medications

Primary outcomes:
measure: Number of Participants with Dose Limiting Toxicity
timeFrame: within 4 weeks
Secondary outcomes:
measure: Mean percent change in atrophic scar volume
timeFrame: 1, 4, 8 and 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jonghee Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kwon HH, Yang SH, Lee J, Park BC, Park KY, Jung JY, Bae Y, Park GH. Combination Treatment with Human Adipose Tissue Stem Cell-derived Exosomes and Fractional CO2 Laser for Acne Scars: A 12-week Prospective, Double-blind, Randomized, Split-face Study. Acta Derm Venereol. 2020 Nov 4;100(18):adv00310. doi: 10.2340/00015555-3666.
citation: Cho YB, Lee WY, Park KJ, Kim M, Yoo HW, Yu CS. Autologous adipose tissue-derived stem cells for the treatment of Crohn's fistula: a phase I clinical study. Cell Transplant. 2013;22(2):279-85. doi: 10.3727/096368912X656045. Epub 2012 Sep 21.
citation: Salloum RH, Rubin JP, Marra KG. The role of steroids in mesenchymal stem cell differentiation: molecular and clinical perspectives. Horm Mol Biol Clin Investig. 2013 Aug;14(1):3-14. doi: 10.1515/hmbci-2013-0016.