louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00056173: Combination of Capecitabine and GTI-2040 in the Treatment of Renal Cell Carcinoma
Official title: A Phase I/II Study of GTI-2040 and Capecitabine Combination Therapy in Patients With Advanced or Metastatic Renal Cell Carcinoma (mRCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Renal Cell
Metastases, Neoplasm
Keywords: Metastatic Renal Cell Carcinoma
Lead sponsor: Aptose Biosciences Inc.
Sponsor class: INDUSTRY
Collaborators: name: Wake Forest University
name: University of Chicago
First posted: 2003-03-10
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II, 43 patient trial, will evaluate the efficacy of GTI-2040, an antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase (RNR) mRNA, in combination with capecitabine, in the setting of advanced/metastatic renal cell carcinoma. Preclinical studies have shown synergy between GTI-2040 and capecitabine against renal cell carcinoma.


Eligibility criteria: * Age greater than or equal to 18.
* Histologically or cytologically confirmed diagnosis of advanced or metastatic renal cell carcinoma for which no effective therapy is available or that is unresponsive to conventional therapy.
* Measurable disease. To be considered measurable, a lesion must be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT scan.
* Karnofsky performance status of greater than or equal to 70.
* Be able to have a central venous like access maintained throughout the study.
* Provide written informed consent prior to the initiation of protocol therapy.
* Appropriate organ function.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Concord
country: United States
facility: Bay Area Cancer Research Group
state: California
city: Los Angeles
country: United States
facility: USC-Norris Comprehensive Cancer Center and Hospital
state: California
city: Torrance
country: United States
facility: CA Hematology Oncology Medical Group
state: California
city: Miami Shores
country: United States
facility: Innovative Medical Research of South Florida, Inc.
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04279873: Use of Microscopy, Cultures and Molecular Biological Methods for Diagnosing Nosocomial Pneumonia
Official title: Use of Microscopy, Cultures and Molecular Biological Methods for Diagnosing Nosocomial Pneumonia in Patients Admitted to the Intensive Care Unit - an Exploratory Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nosocomial Pneumonia
Keywords: Nosocomial, Pneumonia
Diagnostics
16s
18s
PCR
Next Generation Sequencing
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Slagelse Hospital
First posted: 2020-02-21
Enrollment: 22
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: Adult patients with nosocomial pneumonia and the need of mechanical ventilation not intubated for more than 24 hours.

Brief summary: Nosocomial pneumonia in the Intensive Care Unit is often not properly diagnosed mainly due to ongoing antimicrobial therapy. The study investigates the feasibility of more advanced diagnostic technics.

Detailed description: ICU patients fulfilling the CDC criteria for nosocomial pneumonia and mechanically ventilated for no more than 24 hours are included in the study. The material for the diagnostic procedure is pulmonal secretion collected by 1. suctioning in the tracheal tube and 2. bronchioalveolar lavage. The diagnostic procedures are culturing, 16S and18S gene PCR and subsequent sequencing. The 3 diagnostic methods will be compared in order of proper diagnosis and the ability to determine a specific antimicrobial treatment.

Eligibility criteria: Inclusion Criteria:

* Patients intubated because of respiratory failure following nosocomial pneumonia

Exclusion Criteria:

* Terminal patients
* Patients with lung cancer
* Intubated for more than 24 hours at the sampling time
* Not fulfilling the CDC criteria for nosocomial pneumonia

Primary outcomes:
measure: Ratio of patients where the advanced methods are superior to routine
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital
state: Region Sjælland
Study officials:
affiliation: Zealand University Hospital
name: Lone Musaeus Poulsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01453673: Results of Knee Arthroscopic Surgery for Treatment of Cruciate Ligament and Meniscus
Official title: Results of Knee Arthroscopic Surgery for Treatment of Cruciate Ligament and Meniscus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Arthroscopic Surgery
Keywords: knee
Cruciate Ligament
Meniscus
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2011-10-18
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Knee Arthroscopic Surgery patients

Brief summary: This study is a retrospective review of chart. Clinical results including range of motion, muscle power and scores will be recorded. Arthrocopic surgery of cruciate ligament and meniscus will be re-evaluated for clinical application.


Eligibility criteria: Inclusion Criteria:

* ACL reconstructions
* PCL reconstructions
* Meniscectomy or Meniscus repair

Exclusion Criteria:

* Open surgery for knee lesion
* Combined fracture or other associated injury around knee

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University - WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Tai-Yuan Chuang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03378973: The Effects of Dexmedetomidine Dose on Motor Evoked Potentials
Official title: The Effects of Dexmedetomidine Dose on Motor Evoked Potentials During Spine Surgery: A Randomized, Single-blind Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Spinal Fusion
Keywords: motor evoked potentials
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on motor evoked potentials during spine surgery

Detailed description: This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on suitability of motor evoked potentials for intraoperative monitoring during spine surgery

Eligibility criteria: Inclusion Criteria:

* Patients undergoing multi-level posterior spine fusions requiring motor evoked potential monitoring

Exclusion Criteria:

* Allergy to dexmedetomidine, propofol
* Conditions knows to make recording of motor evoked potentials difficult, including poorly controlled diabetes, severe peripheral neuropathy, severe myelopathy, or previous surgery during which motor evoked potentials were difficult to obtain
* Hepatic disease

Primary outcomes:
measure: Percent of Patients With Monitorable of Motor Evoked Potentials
timeFrame: During a single surgery for the duration of the operation
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Ronald Emerson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00379873: Chiropractic Adjustment on Physiological Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2006-09-25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This research is designed to study the effects of chiropractic adjustment on the physiological responses (EEG, EMG, HRV, skin temperature, and respiration) of college student and faculty population.


Eligibility criteria: Inclusion Criteria:

Asymptomatic subjects (without somatosensory peripheral pain) will be recruited in the study.

Exclusion Criteria:

Subjects with heart failure and any nervous system diseases will be excluded from the study. Additional exclusions include osteoporosis, pregnancy, diabetes, vascular insufficiency, and history of joint replacement therapy. Subjects under medical treatment, surgery and trauma within six months will be excluded

Primary outcomes:
measure: to understand the physiological response of a chiropractic adjustment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Logan College of Chiropractic
name: John Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Logan College of Chirppractic
name: Rodger Tepe, PhD
role: STUDY_DIRECTOR
References:
citation: DeVocht JW, Pickar JG, Wilder DG. Spinal manipulation alters electromyographic activity of paraspinal muscles: a descriptive study. J Manipulative Physiol Ther. 2005 Sep;28(7):465-71. doi: 10.1016/j.jmpt.2005.07.002.
Clinical trial NCT03677973: A Study to Investigate the Safety of AB680 in Healthy Volunteers
Official title: A Double-Blind, Randomized, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB680 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Arcus Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a double-blind, randomized, placebo-controlled, single- and multiple-ascending dose study to investigate the safety, tolerability, and pharmacokinetic profile of AB680 in healthy volunteers.

Detailed description: AB680 will be administered as single and multiple intravenous doses to the healthy volunteers. In each group of 8 participants, 6 will receive AB680 and 2 will receive matching placebo.

The participants will be closely observed to monitor the general tolerability of AB680.

Eligibility criteria: Inclusion Criteria:

* 18 to 55 years, inclusive, at screening
* Body mass index 18 to 30 kg/m2
* Willing and able to sign informed consent
* Negative tests for hepatitis B surface antigen, anti-hepatitis C virus, and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening
* Healthy as determined by pre-study screening

Exclusion Criteria:

* History of clinically significant drug and/or food allergies
* Positive drug and alcohol screen at screening and (each) admission to the clinical research center.
* Participation in a drug study within 60 days prior to (the first) drug administration in the current study. Participation in more than 4 other drug studies in the 12 months prior to (the first) drug administration in the current study
* Participants who have significant infection or known inflammatory process on screening or admission

Primary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs).
timeFrame: From First Dose Date to 15 Days After the Last Dose of AB680.
measure: AB680 Peak Plasma Concentration (Cmax)
timeFrame: From First Dose Date to 15 Days After the Last Dose of AB680.
measure: AB680 Time of Peak Concentration (Tmax)
timeFrame: From First Dose Date to 15 Days After the Last Dose of AB680.
Secondary outcomes:
measure: Pharmacodynamic (PD) Effects of AB680
timeFrame: From First Dose Date to 15 Days After the Last Dose of AB680.
measure: Plasma Levels of Adenosine
timeFrame: From First Dose Date to 15 Days After the Last Dose of AB680.
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Melbourne, VIC
state: Victoria
Study officials:
References:
citation: Bowman CE, da Silva RG, Pham A, Young SW. An Exceptionally Potent Inhibitor of Human CD73. Biochemistry. 2019 Aug 6;58(31):3331-3334. doi: 10.1021/acs.biochem.9b00448. Epub 2019 Jul 23.
Clinical trial NCT01623973: Impact of Restriction of the Non Paretic Upper Limb Rehabilitation of Patients a With Stroke:Randomized Clinical Trial
Official title: Impact of the Restriction of the Non Paretic Upper Limb in Rehabilitation of Patients Post-stroke:Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: hemiparetic
cognitive
balance
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate whether the restriction of the non paretic upper limb (UL) is a factor that could interfere at the sensorimotor UL recovery for chronic stroke subjects and to verify the impact on daily function, quality of life. In this pilot, randomized, blind and allocation concealment clinical trial, nineteen individuals with chronic stroke was randomly assigned, after the first evaluation, into two groups: group without restriction (G1), subject only to the specific training of paretic UL, and restricted group (G2), which underwent specific training of paretic UL and use of the restriction of non paretic UL


Eligibility criteria: Inclusion Criteria:

* ability to actively extend at least 10° at the metacarpophalangeal the wrist;
* more than 6 months post onset of stroke;

Exclusion Criteria:

* Mini-Mental State Examination;
* no excessive spasticity in any joints of the affected.

Primary outcomes:
measure: To investigate the impact that the restriction of non-paretic upper limb recovery would have on sensorimotor with Fugl-Meyer Scale
timeFrame: 1 year
Secondary outcomes:
measure: Functional Independence Measure (FIM)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06786273: Time Course of Endometrium's Gene Expression Profiles Using Endometrial Tissue and Blood Samples
Official title: Time Course of Endometrium's Gene Expression and DNA Methylation Profiles Using Endometrial Tissue and Blood Samples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Fertility
Keywords: miRNAs
microRNAs
time course
blood
Lead sponsor: Inti Labs
Sponsor class: INDUSTRY
First posted: 2025-01-22
Enrollment: 62
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate whether the expression levels of microRNA (miRNA) in endometrial tissue and blood samples at various time points after ovulation can serve as biomarkers for assessing endometrial receptivity.


Eligibility criteria: Inclusion Criteria:

* Regular menstrual cycle of 28-32 days.
* Between 25-38 years old.
* BMI between 18 to 30.
* Endogenous progesterone (P4) level of \< 1 ng/mL prior to exogenous progesterone administration

Exclusion Criteria:

* Suspected intrauterine abnormality.
* Women who are breastfeeding
* Have a history of pelvic inflammatory disease, reproductive tract-related diseases, sexually transmitted diseases, systemic diseases or endocrine diseases.
* History of major illness.
* Use of hormonal contraceptives or intrauterine devices in the past 3 months.

Primary outcomes:
measure: miRNA expression profiles
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Lee Women's Hospital
Study officials:
References:
Clinical trial NCT03276273: Bispectral-Electroencephalography (EEG) in First Time Hemodialysis
Official title: The Utility of Using the Bispectral Index (BIS) for Detecting Dialysis Disequilibrium Syndrome (DDS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Failure Acute Chronic
Lead sponsor: Suez Canal University
Sponsor class: OTHER
Collaborators: name: Dalian Medical University
First posted: 2017-09-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First Time renal Dialysis

Brief summary: The severity of minimal dialysis disequilibrium syndrome (DDS) is currently detected and graded clinically using clinical criteria. Bispectral Index (BIS), an electroencephalographic (EEG) derived parameter is widely used in anesthesia and Critical Care setting to detect effects of anesthetic/hypnotic drugs. The aim of our study was to assess the discriminative power of BIS monitoring to accurately detect DDS.

Detailed description: Design: A consecutive, clinical, validation study. Setting: Medical University of Graz (Graz, Austria). Patients: Twenty consecutive patients undergoing first hemodialysis are enrolled at Medical University of Graz, Haemodialysis Unit. Agitated patients or patients who fell asleep during the recording are excluded from the final analysis.

During the first dialysis session of approximately 3 h, patients were observed for signs of disequilibrium; headaches, dizziness, nausea, vomiting, if they become obtunded, have visual impairments or cramps. Accordingly patients were divided into 2 groups; the "DDS group" of patients who experienced one of the DDS symptoms of headaches, dizziness, nausea, vomiting, become obtunded, have visual impairments or cramps and patients who do not experience any of the DDS symptoms in the "non-DDS group" An assigned nephrologist will assess the physical and mental status of the patients.

Eligibility criteria: Inclusion Criteria:

* First Time renal Dialysis

Exclusion Criteria:

* subjects' consumption of sedatives/hypnotics psychotropic drugs, or concomitant neurological disorders affecting mental state such as hepatic encephalopathy, stroke, stupor or dementia and renal transplant patients.

Primary outcomes:
measure: Change in the Bispectral Index value
timeFrame: Over a period of one year Time point 1= First Hemodialysis, Time point 2= Second Hemodialysis, Time point 3= Third Hemodialysis.
Secondary outcomes:
Other outcomes:
Locations:
city: Dalian
country: China
facility: Dalian Medical University
city: Cairo
country: Egypt
facility: Theodor Bilharz Research Institute
Study officials:
affiliation: Guest Professor
name: Ashraf Dahaba, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04508673: Impact of GH Measurements on GHD Diagnosis
Official title: Comparative Study of Human Growth Hormone Measurements: Impact on Clinical Interpretation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Deficiency
Keywords: growth hormone deficiency
immunoanalysis
hGH provocation test
diagnosis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 41
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From April to November 2019, forty-one young patients (26 boys and 15 girls) from the Paediatric Department of Montpellier Hospital were included in this study. They were mainly admitted for suspicion (short stature or growth retardation) or follow-up of GHD in pre-and pubertal age (median age= 12).

Brief summary: Human growth hormone (hGH) provocation test is an essential tool to assess growth hormone deficiency in children and young adults. It is important to have a robust and reliable method to determine the hGH peak of stimulation. This work aimed to compare three common automated immunoassays for hGH measurements and to assess whether there are still result-related differences influencing clinical decision.

Detailed description: The investigators analysed GH provocative test of 41 young patients (median age: 12 years) from Pediatric Department of Montpellier Hospital, (26 boys and 15 girls), admitted for follow-up or for suspicion of growth hormone deficiency. Serum GH of peak concentrations were compared using three automated immunoanalyses : COBAS 8000 e602 (ROCHE Diagnostics), IDS-iSYS (IDS immunodiagnostic systems) and Liaison XL (Diasorin S.A.).

Eligibility criteria: Inclusion criteria:

* Age\<18 years, admitted for suspicion (short stature or growth retardation) or follow-up of GHD in pre-and pubertal age
* patients undergoing insulin-induced hypoglycaemia stimulation test also called insulin tolerance test (ITT)
* Exclusion criteria:
* Age \> 18 years
* Patients undergoing different provocation tests

Primary outcomes:
measure: Comparative study of human growth hormone measurements
timeFrame: 1 day
Secondary outcomes:
measure: Stratification of patients based on GH peak secretion
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH MONTPELLIER
name: Manuela Lotierzo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lotierzo M, Olaru-Soare F, Dupuy AM, Plawecki M, Paris F, Cristol JP. Comparative study of human growth hormone measurements: impact on clinical interpretation. Clin Chem Lab Med. 2021 Dec 2;60(2):191-197. doi: 10.1515/cclm-2021-1109. Print 2022 Jan 27.