louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00292071: Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia (0991-042)
Official title: A Multicenter, Open, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of 2 Separate Doses of Caspofungin Acetate in Children Between the Ages of 3 to 24 Months With New Onset Fever and Neutropenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fungal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-02-15
Enrollment: 16
Sex: ALL
Minimum age (years): 3
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label study of MK0991 in children between 3 to 24 months of age with new onset fever and neutropenia. The purpose of the study is to investigate plasma drug levels of caspofungin.


Eligibility criteria: Inclusion Criteria:

* Patient is 3 to 24 months of age with one or more of the following conditions:
* Leukemia, lymphoma, or other cancers
* Bone marrow or peripheral stem transplantation
* High dose chemotherapy leading to a decrease in white blood cells
* Aplastic anemia
* Patient has an absolute neutrophil count \<500 mm3 (a specific type of white blood cell that fights infection) AND at least one recording of fever \> 38 degreesC (oral or oral equivalent) within 72 hours of screening.

Exclusion Criteria:

* Patient is \<3 months or \>24 months of age at the time of study drug administration
* Patient has proven or probable invasive fungal infection at the time of enrollment
* Patient has certain blood clotting or liver function abnormalities
* Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days
* Patient is taking rifampin, cyclosporin A, phenytoin, carbamazepine, or phenobarbital.

Primary outcomes:
measure: Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults.
timeFrame: 28 Days
Secondary outcomes:
measure: Caspofungin is generally safe and well tolerated in children 3 to 24 months of age.
timeFrame: 28 Days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Neely M, Jafri HS, Seibel N, Knapp K, Adamson PC, Bradshaw SK, Strohmaier KM, Sun P, Bi S, Dockendorf MF, Stone JA, Kartsonis NA. Pharmacokinetics and safety of caspofungin in older infants and toddlers. Antimicrob Agents Chemother. 2009 Apr;53(4):1450-6. doi: 10.1128/AAC.01027-08. Epub 2008 Dec 29.
Clinical trial NCT05666271: Radiofrequency Ablation for Hepatocellular Carcinoma Using Octopus MP Electrodes
Official title: Radiofrequency Ablation for Small Hepatocellular Carcinoma Using Octopus MP Electrodes or Octopus Electrodes With Adjustable Tips: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have been referred for radiofrequency ablation for the treatment of small hepatocellular carcinomas (equal or less than 3 cm) located in the periphery of the liver (within 5 cm from the liver capsule) on preprocedural computed tomography or magnetic resonance imaging.

Brief summary: This study is to investigate the therapeutic effect and treatment results of radiofrequency ablation using the Octopus MP electrode capable of temperature monitoring and drug injection and a variable-length electrode for treatment of small hepatocellular carcinomas (≤ 3cm).


Eligibility criteria: Inclusion Criteria:

* Child-Pugh Class A or B
* chronic hepatitis B or chronic hepatitis C or liver cirrhosis
* presence of hepatocellular carcinoma (HCC) after confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to the Korean Liver Cancer Study Group (KLCSG)-National Cancer Center (NCC) Korea practice guidelines.
* up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment.

Exclusion Criteria:

* number of recurrent HCCs, more than 3
* largest HCC size over 3 cm
* presence of vascular invasion by HCC
* platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%
* presence of extrahepatic metastasis

Primary outcomes:
measure: Adjacent organ thermal injury rate
timeFrame: Immediately after radiofrequency ablation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT02669771: Long-Term Specified Drug Use-Results Survey for Xtandi Capsule
Official title: Xtandi® Capsules 40 mg Protocol for Long-Term Specified Drug Use-Results Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Castration-resistant Prostate Cancer
Keywords: Xtandi
MDV3100
long term use
enzalutamide
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2016-02-01
Enrollment: 1018
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with castration-resistant prostate cancer

Brief summary: The purpose of this study is to confirm the long term safety and efficacy of enzalutamide in patients.


Eligibility criteria: Inclusion Criteria:

* no history of treatment with enzalutamide

Exclusion Criteria:

-

Primary outcomes:
measure: Incidences of Adverse Events
timeFrame: Up to 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 2 years
measure: Change from baseline in PSA value
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Aichi
country: Japan
city: Akita
country: Japan
city: Aomori
country: Japan
city: Chiba
country: Japan
city: Ehime
country: Japan
city: Fukui
country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Gifu
country: Japan
city: Gunma
country: Japan
city: Hiroshima
country: Japan
city: Hokkaido
country: Japan
city: Hyogo
country: Japan
city: Ibaraki
country: Japan
city: Ishikawa
country: Japan
city: Iwate
country: Japan
city: Kagawa
country: Japan
city: Kagoshima
country: Japan
city: Kanagawa
country: Japan
city: Kochi
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Mie
country: Japan
city: Miyagi
country: Japan
city: Miyazaki
country: Japan
city: Nagano
country: Japan
city: Nagasaki
country: Japan
city: Nara
country: Japan
city: Niigata
country: Japan
city: Oita
country: Japan
city: Okayama
country: Japan
city: Okinawa
country: Japan
city: Osaka
country: Japan
city: Saga
country: Japan
city: Saitama
country: Japan
city: Shiga
country: Japan
city: Shimane
country: Japan
city: Shizuoka
country: Japan
city: Tochigi
country: Japan
city: Tokushima
country: Japan
city: Tokyo
country: Japan
city: Tottori
country: Japan
city: Toyama
country: Japan
city: Wakayama
country: Japan
city: Yamagata
country: Japan
city: Yamaguchi
country: Japan
city: Yamanashi
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02123771: Gamma-Glutamyl Transpeptidase (GGT): A Potential Diagnostic Marker for Helicobacter Pylori Infections
Official title: Gamma-Glutamyl Transpeptidase (GGT): A Potential Diagnostic Marker for Helicobacter Pylori Infections
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HELICOBACTER PYLORI INFECTIONS
Keywords: Focus of Study : HELICOBACTER PYLORI INFECTIONS
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 100 patients seen in Gastro clinic will be recruited for this study. Patient should 21 years and above and agreeable for study. Patient should not have been treated for H. pylori prior to stool collection.

Brief summary: The investigators hypothesis:

Presence of anti-GGT (antibody against GGT) indicates H. pylori infection.

Detailed description: Subjects will be requested to provide 1-5g of their solid/semi-solid stool sample, to be collected within 24 hours prior to their scheduled visit for urea breath test. Patients should not have been treated for H. pylori prior to stool collection. Stool samples will be tested using ELISA for the presence of the H. pylori GGT antigen using monoclonal antibodies against GGT. Stool samples will also be tested for the presence of H. pylori DNA using PCR and Western blot analysis respectively.

Presence of the GGT antigen in stool will be compared between H. pylori-positive and H. pylori-negative patients. Rapid urease test results will be used as the gold standard of H. pylori diagnosis. The sensitivity and specificity of the stool antigen test will be established.

Eligibility criteria: Inclusion Criteria:

* The subject is greater than 21 years of age.
* The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
* The subject must be willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

* Subjects who have been taking antibiotics over the past 1 month will be excluded from study.

Primary outcomes:
measure: Stool anti-GGT for the diagnosis of Helicobactor Pylori Infection
timeFrame: 1 month after stool samples collected
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Nuhs Umc/Udc
Study officials:
affiliation: NUHS
name: Lee Guan Lim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gong M, Ling SS, Lui SY, Yeoh KG, Ho B. Helicobacter pylori gamma-glutamyl transpeptidase is a pathogenic factor in the development of peptic ulcer disease. Gastroenterology. 2010 Aug;139(2):564-73. doi: 10.1053/j.gastro.2010.03.050. Epub 2010 Mar 27.
Clinical trial NCT03311971: Single Center Study Evaluating the Possible Effect of Virtual Reality Spectacles on Pain Following Total Knee Replacement Surgery
Official title: Single Center Study Evaluating the Possible Effect of Virtual Reality Spectacles on Pain Following Total Knee Replacement Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain Post Joint Arthroplasty
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of intervention with conventional therapy. The intervention group includes use of virtual reality spectacles. The control group includes routine postoperative care
Primary purpose: TREATMENT

Brief summary: The trial aims to evaulate the possiblity that use of virtual reality spectacles will affect post operative pain in total knee arthroplasty patients. The trial is a single center open label design. Patients will be randomized into two arm study comparing the effect of the use of virtual reality spectacles on pain levels and analgesic consumption in the perioperative period. The controls shall receive standard post operative care. The endpoints are VAS levels and analgesic use.

Detailed description: Evaluation Procedure This is a single center, interventional, randomized, unblinded two arm study assessing pain and analgesic use in post knee arthroplasty patients. The randomization ratio is 2:1 intervention to control. Both groups will receive routine post operative care. The intervention group will be treated with virtual reality spectacles. The control group will receive routine post operative care. Pain levels will be assessed using VAS and analgesic use.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing total knee arthroplasty gender indifferent, aged over 18 years old
* Patient with ability to see in three dimensions

Exclusion Criteria:

* Inability to comply with the study protocol
* Single eye vision
* Blindness

Primary outcomes:
measure: VAS pain response
timeFrame: One week
Secondary outcomes:
measure: Analgesic use
timeFrame: one week
Other outcomes:
Locations:
city: Petaẖ Tiqwa
country: Israel
facility: Hasharon Hospital
Study officials:
References:
Clinical trial NCT03159871: Closing Uterine Incision During C-section Using Barbed Suture (Stratafix) or Vicryl Suture.
Official title: Closing Uterine Incision During C-section Using Barbed Suture (Stratafix) or Vicryl Suture: a Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: Cesarean section
C- section
Suture
Lead sponsor: Barzilai Medical Center
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the suturing time during C-Section.

Detailed description: A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the suturing time during C-Section. In addition, the need of additional sutures to control bleeding after the 2- layer closure will be estimated.These will be the primary outcome measures. The secondary outcome measures will be factors related to the blood loss at the time of the uterine closure, surgical complications, duration of hospital stay, postoperative infection (endometritis) and wound infection..

Eligibility criteria: Inclusion Criteria:

• Pregnant patients with an obstetrical indication for delivery by Cesarean section

Exclusion Criteria:

• Patients with blood clotting disorders.

Primary outcomes:
measure: Time required for uterine closure.
timeFrame: From the beginning of first uterine suture till the last suture ending uterine incision complete closure and any additional hemostatic sutures if applicable. The estimated period of time is 8 minutes (average).
Secondary outcomes:
measure: Blood loss during uterine closure
timeFrame: Estimated period of time is 4 days.
Other outcomes:
Locations:
city: Ashqelon
country: Israel
facility: Barzilai Medical Center
Study officials:
References:
citation: Greenberg JA, Goldman RH. Barbed suture: a review of the technology and clinical uses in obstetrics and gynecology. Rev Obstet Gynecol. 2013;6(3-4):107-15.
citation: Giampaolino P, De Rosa N, Tommaselli GA, Santangelo F, Nappi C, Sansone A, Bifulco G. Comparison of bidirectional barbed suture Stratafix and conventional suture with intracorporeal knots in laparoscopic myomectomy by office transvaginal hydrolaparoscopic follow-up: a preliminary report. Eur J Obstet Gynecol Reprod Biol. 2015 Dec;195:146-150. doi: 10.1016/j.ejogrb.2015.10.011. Epub 2015 Oct 24.
Clinical trial NCT00624871: Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy
Official title: Ascorbic Acid Combined With Ibuprofen in Hypoxic Ischemic Encephalopathy: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxic Ischemic Encephalopathy
Perinatal Asphyxia
Keywords: Interleukin 1-beta
Interleukin 6
Vitamin C
HIE
neonates
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2008-02-28
Enrollment: 60
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oxygen radicals and inflammation are important causes for brain injury in neonates following perinatal asphyxia. Animal studies demonstrated potential benefits to the brain when using both of vitamin C and ibuprofen. The efficacy of these 2 drugs when combined in protecting the human brain has not been studied. We aimed in this study to test the hypothesis that a combination of anti-oxidants (vitamin C) and anti-inflammatory (ibuprofen) drugs can decrease the brain injury in perinatal asphyxia and improve outcomes when given to infants immediately after birth.


Eligibility criteria: Inclusion Criteria:

* Apgar score at 5 minutes \< 6
* Profound metabolic or mixed acidosis with pH \< 7 in the initial blood gas
* Evidence of encephalopathy such as coma, seizures or hypotonia
* Evidence of multi-system compromise, in addition to encephalopathy

Exclusion Criteria:

* Major congenital anomalies
* Early sepsis
* Gastrointestinal bleeding
* Thrombocytopenia

Primary outcomes:
measure: DDST-II
timeFrame: 6 months
measure: Neurological Examination
timeFrame: 6 months
Secondary outcomes:
measure: Death
timeFrame: On Discharge
measure: Neurological Examination
timeFrame: On Discharge
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Bab El-Shariya Hospital
Study officials:
affiliation: Al-Azhar University
name: Ahmed Elsayed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Azhar University
name: Laila Abd-Rabboh, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06368271: Acute Effects of Dietary Medium-chain Fatty Acids on Lipid Profile
Official title: Acute Effects of Dietary Medium-chain Fatty Acids on Llipid Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Nutrition
Diet, Healthy
Keywords: medium-chain fatty acids
lipidomics
acute intervention
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 4
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a randomized, double-blinded crossover design. Participants ingest Medium-chain-fatty acids (MCT) or Long-chain fatty acids (LCT) oil on two test days with one-week period between the experimental days. The day prior to the experimental days, the participants consume a eucaloric control diet, and abstain from alcohol and vigorous physical activity to ensure similar conditions on experimental days.
Primary purpose: BASIC_SCIENCE

Brief summary: In the present study the plasma lipid profile was elucidated in healthy, lean males by the use of lipidomic analysis in the hours after an acute intake of medium-chain fatty acids (MCT) and long chain fatty acids (LCT),, respectively. In addition oxygen uptake was measured to study energy turnover.

Detailed description: Four participants ingested MCT or LCT oil on two test days with one-week period between the experimental days. The day prior to the experimental days, the participants consumed a eucaloric control diet, and abstained from alcohol and vigorous physical activity to ensure similar conditions on experimental days.

On the test days, participants arrived by passive transport in the overnight fasted state (12 h) at 8 a.m., and a catheter was inserted into an antecubital vein. Following 30 min in supine rest, an overnight-fasted, basal venous blood sample was obtained. Subsequently, participants ingested the same test drink as in study 1 (containing 35g of MCT or LCT oil diluted in 100g of low-fat, low-carbohydrate cocoa milk) within five min. 100 ml water was provided together with the test drink. Venous blood samples were drawn every 30 min for the first two hours and every 60 minutes for the last two hours following intake. Participants rested in a bed throughout the test day. this This process was repeated on the second test day.

Eligibility criteria: Inclusion Criteria:

healthy males BMI:20-27 recreationally physical active non-smoker no medicine

-

Exclusion Criteria:

* high habitual intake of MCT-rich foods as coconut, coconut oil and dairy products

Primary outcomes:
measure: Meal test including medium-chain fatty acids
timeFrame: 0-4 hours
Secondary outcomes:
measure: Resting metabolic rate
timeFrame: 0-4 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports
Study officials:
affiliation: University of Copenhagen
name: Bente Kiens, D.sci, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02947971: Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System
Official title: Pilot Study for TCE (Tethered Capsule Endomicroscopy) Imaging of the Esophagus Using an OFDI (Optical Frequency Domain Imaging) Capsule With a Compact Imaging System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Barrett's Esophagus
Keywords: Device
OFDI
Tethered Capsule Endomicroscopy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2016-10-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this research is to test a distal scanning capsule and a compact redesigned version of the OFDI imaging system in healthy and BE subjects to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.

Detailed description: Ten healthy volunteer subjects and ten volunteers with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled in the study.

The capsule is attached to a string-like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using peristalsis.

Images of the esophagus will be acquired in real time to be analyzed later.

Eligibility criteria: Inclusion Criteria:

* A previous diagnosis of BE (not an inclusion criteria for healthy volunteers)
* Subjects must be over the age of 18 but less than 70 year of age.
* Subjects must be able to give informed consent
* Subjects must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.

Exclusion Criteria:

* Subjects over 70 years of age
* Subjects with the inability to swallow pills and capsules.
* Subjects with a strong gag reflex
* Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
* Pregnancy. If the subject is unsure, she will be asked to take a pregnancy test.

Primary outcomes:
measure: Assessment of quality and performance of Compact Imaging System (CIS)
timeFrame: 5-7 Minutes of imaging
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: