louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00113113: Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction
Official title: Phase I Study of Rubitecan (RFS 2000) in the Treatment of Cancer Patients With Organ Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Keywords: rubitecan
Orathecin
9-nitrocamptothecin
solid tumors
organ dysfunction
renal dysfunction
hepatic dysfunction
RFS 2000
Lead sponsor: Astex Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2005-06-06
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cancer patients with liver or renal dysfunction will be treated with rubitecan capsules to define the maximum tolerated dose and the dose-limiting toxicity in this patient population, and to perform pharmacokinetic studies of rubitecan in this patient population.


Eligibility criteria: Inclusion Criteria:

* The patient is at least 18 years of age.
* The patient has histologically or cytologically proven malignancy recurrent or refractory to standard treatment or for which there is no standard therapy.
* The patient has measurable disease.
* The patient has sufficiently recovered from the acute toxic effects of previous chemotherapy, radiotherapy (no less than 3 weeks prior to randomization), and/or immunotherapy.
* The patient's estimated life expectancy is at least 8 weeks.
* The patient has a National Cancer Institute Common Toxicity Criteria (NCI CTC) Performance Status between 0 and 2.
* The patient has adequate bone marrow function.
* The patient must not have active central nervous system (CNS) metastases.

Exclusion Criteria:

* The patient has any serious, uncontrolled intercurrent illness or infection.
* The patient is receiving anti-retroviral therapy (HAART) for HIV infection.
* The patient is pregnant or nursing.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: The Center for Cancer Care and Research
state: Missouri
Study officials:
References:
Clinical trial NCT03377413: Novel Equation for Estimating Resting Energy Expenditure
Official title: Novel Equation for Estimating Resting Energy(REE) Expenditure in Chronic Kidney Disease(CKD) 3-5 Stages Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resting Energy Expenditure
Chronic Kidney Disease
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic kidney disease 3-5 stages

Brief summary: The energy and nutrition states are closely associated with CKD patients complications and outcomes.To reach the energy balance target, we need the accurate resting energy expenditure level of patients. Traditional equations are not applicable to CKD patients,so we aim to develop and validate a equation for estimating resting energy expenditure in CKD patients.


Eligibility criteria: Inclusion Criteria:

* CKD 3-5 stages
* Age:18-80 years old

Exclusion Criteria:

* Dialysis and kidney transplantation;
* Acute complications to hospitalization
* 1 month prior to the study;
* Acute or chronic infections, cancer and other wasting diseases in the past year;
* Thyroid dysfunction;
* Acute onset of podagra; Musculoskeletal diseases;
* Respiratory diseases (asthma, pleural effusion, pneumothorax, COPD);
* History of hormonal drugs use;
* During pregnancy or lactation

Primary outcomes:
measure: Novel equation development
timeFrame: September 1, 2017 to June 1, 2018
measure: Novel equation validation
timeFrame: June 1, 2018 to March 1, 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Renal Division and Institute of Nephrology, Peking University First Hospital
state: Beijing
Study officials:
affiliation: Renal Division and Institute of Nephrology, Peking University First Hospital
name: Jie Dong
role: STUDY_DIRECTOR
References:
citation: Xu X, Yang Z, Ma T, Li Z, Chen Y, Zheng Y, Dong J. Novel equation for estimating resting energy expenditure in patients with chronic kidney disease. Am J Clin Nutr. 2021 Jun 1;113(6):1647-1656. doi: 10.1093/ajcn/nqaa431.
Clinical trial NCT00676013: Comparison of Skin Substitutes Used in Burn Care
Official title: The Use of Alloderm and Other Skin Substitutes in Acute Burn Treatment and Burn Scar Reconstruction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Burns
Keywords: Burns
Skin grafting
AlloDerm
Integra
Homograft
Autograft
Burn Scar
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2008-05-12
Enrollment: 158
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if using a DERMAL LAYER under skin grafts:

1. will reduce scar formation of skin grafts
2. will reduce burn wound contractures
3. will improve functional outcome of joints requiring grafts

Compare scarring outcome of Dermal products

Detailed description: Various skin substitutes are compared for healing, scar and functional and cosmetic outcomes.

Eligibility criteria: Inclusion Criteria:

* Burn injury requiring grafting
* 0 years-90 years

Exclusion Criteria:

* Partial thickness burns only

Primary outcomes:
measure: Burn Scar Comparison
timeFrame: 2 years post burn injury
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch, Galveston
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: David N Herndon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01407913: Caudal Epidural Steroid Injections for Low Back Pain/Sciatic Lumbar Pain
Official title: Efficacy Study of Caudal Epidural Steroid Injections in Patients With Low Back Pain/Radiculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Disability
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2011-08-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study hypothesis is that caudal epidural steroid injections provides short term relief to patients with persistent low back pain and sciatica due degenerative disc disease or lumbar spinal stenosis. Patients will be evaluated wiht clinical examination and radiological examinations before injections. They will be followed up with questionnaires on pain and disability up to 6 months postinjection.


Eligibility criteria: Inclusion Criteria:

* low back pain and sciatica due to lumbar disc herniation or lumbar spinals stenosis

Exclusion Criteria:

* infection, cancer, allergy to steroids or anesthetic, non controlled diabetes or hypertension, clotting disorder

Primary outcomes:
measure: change from preinjection of oswestry disability index at 15 days and at 3-6 months postinjection
timeFrame: pre injection to 3-6 months postinjection
measure: change from preinjection of Visual Analogue Scale at 15 days and at 3-6 months postinjection
timeFrame: preinjection to 3-6 months postinjection
Secondary outcomes:
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
Study officials:
References:
Clinical trial NCT05015413: Effect of Shockwave Versus LLL Therapy on Sacroiliac Joint Pain in Postnatal Women
Official title: Effect of Shockwave Versus Low Level Laser Therapy on Sacroiliac Joint Pain in Postnatal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sacroiliac Joint Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A will receive shock wave therapy Group B will receive low level laser therapy
Primary purpose: TREATMENT

Brief summary: Sacroiliac joint pain is the most causes of back pain In pregnancy caused ligament laxity in sacroiliac joint so cause pain and this pain continue after natal Shock wave is new conservative treatment used in physical therapy Shock wave is most effective for sacroiliac joint pain Low level laser is a most effective pain relive and effective on sacroiliac joint pain

Detailed description: The study is to determine if there is any difference between the effect of shockwave and low level laser therapy on sacroiliac joint pain in postnatal women This study will be randomly distributed into two equal group Group A consisted of 25 postpartum women complaining from sacroiliac joint pain . They will receive shockwave therapy 2 session per week for 6 weeks Group B consisted of 25 postpartum women complaining from sacroiliac joint pain . They will receive low level laser therapy 2 session per week for 6 weeks

Evaluation procedures History taking recording in recording data sheet Weight and height measurement by calculate BMI Disability assessment by OWDI Pain assessment by VAS scale Assessment of pressure of pain threshold by pressure algometry

Eligibility criteria: Inclusion Criteria:

* postnatal women suffering from sacroiliac joint pain for at least 3 months.
* They should have moderate to severe pain .
* They should have positive findings in at least 3 of 5 provocation sacroiliac joint tests

Exclusion Criteria:

* lumber or hip joint pathology
* Acute pelvic bacterial or viral infection .
* Receiving corticosteroid injections within the previous 6 weeks

Primary outcomes:
measure: Sacroiliac joint pain
timeFrame: About two months
measure: Functional disability
timeFrame: About 2 month
measure: Pain pressure threshold
timeFrame: About 2 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00704613: Planning Margin Requirements for Pediatric Radiation Oncology
Official title: Planning Margin Requirements for Pediatric Radiation Oncology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Radiation
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2008-06-25
Enrollment: 375
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving external beam radiation therapy at St. Jude Children's Research Hospital will be screened for participation on this research protocol based on the Inclusion Criteria.

Brief summary: The planning target volume (PTV) and planning organ at risk volume (PRV) margins used for pediatric radiation therapy are empiric, and quantitative assessment of these margins is needed to improve therapy planning and delivery.

Detailed description: Data will be gathered to develop a model to quantify the setup margin (SM) portion of the planning target volume (PTV) margin for pediatric tumor sites according to age, localization technique, treatment position, and the use of general anesthesia. Patient specific PTV and PRV margin recommendations will be developed based on the number of participants.

Eligibility criteria: Inclusion Criteria:

* Patients will receive conformal or intensity-modulated radiation therapy (3D or IMRT).
* Research participant or legal guardian/representative gives written informed consent.

Exclusion Criteria:

* Unwillingness of research participant or legal guardian/representative to give written informed consent

Primary outcomes:
measure: Acquire data to develop setup margin (SM) portion of the planning target volume (PTV) margin for pediatric tumor sites according to age, localization technique, treatment position, and the use of general anesthesia.
timeFrame: 4 year
Secondary outcomes:
measure: Estimate the number of patients required to develop a patient specific PTV and RTV margin recommendations.
timeFrame: 4 year
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Thomas Merchant, DO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04479813: Role of Sympathetic Activation in Ischemia Reperfusion Injury
Official title: Role of Sympathetic Activation in Ischemia Reperfusion Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Central Sympathetic Nervous System Diseases
Keywords: Ischemia
re-perfusion
Remote conditioning
Lead sponsor: Royal Perth Hospital
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to assess the effect of forearm ischemia-reperfusion injury on sympathetic nerve activity. To determine whether reduced sympathetic responsiveness is a contributor to the protective effects of remote ischemic preconditioning. In addition it will assess whether pharmacologic inhibition of the sympathetic nervous system can ameliorate ischemia reperfusion injury induced endothelial dysfunction.

Detailed description: This is a randomized single blind study where subjects will be allocated to undergo one of the 4 protocols. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20 minutes prior to the first endothelial function measurement.

This medication acts by reducing the activity of nerves believed to be involved in the conditioning process. The placebo pill, designed to have no effect, will be used as a comparison. Comprehensive tests will occur which include Microneurography, Endothelial function ,Blood Sampling, Temporary block of arm blood flow and Remote conditioning

Eligibility criteria: Inclusion Criteria:

* healthy males, not on any medication, free of any history of metabolic, cardiovascular or cerebrovascular disease.

Exclusion Criteria:

* smoker

Primary outcomes:
measure: change in muscle sympathetic nerve activity
timeFrame: 1 day
Secondary outcomes:
measure: Endothelial Function using the EndoPat2000 device
timeFrame: 2 days
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Dobney Hypertension Centre
Study officials:
affiliation: Royal Perth Hospital
name: Markus Schlaich, MD,FAHA,FESC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01807013: Evaluating Ultrasound, Elastometry, Minilaparoscopy and Histology for the Diagnosis of Compensated Liver Cirrhosis.
Official title: Prospective Study to Evaluate the Diagnostic Value of B-mode Ultrasound, Elastometry and Minilaparoscopic Guided Liver Biopsy for the Diagnosis of Compensated Liver Cirrhosis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cirrhosis
Keywords: cirrhosis
liver
elastometry
ultrasound
laparoscopy
diagnosis
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with suspected chronic liver disease

Brief summary: Prospective study to evaluate the dignostic value of b-mode ultrasound, elastometry and mini-laparoscopic guided liver biopsy for the diagnosis of compensated liver cirrhosis.

Detailed description: Up to now the gold standard for the diagnosis of liver cirrhosis is to perform liver biopsy. This invasive methode is not undisputed. Therefore there is constant effort to improve, develop and apply better diagnostic tools. This study is designed to evaluate the in our eyes now a days most promising examinations: (1) high frequency ultrasound, (2) elastometry and (3) minilaparoscopy. Patients for whom the clinical decision to perform mini laparoscopic guided liver biopsy was taken should be recruited. Successive at three time points the examiner has to decide for or against cirrhosis: (1) after conventional and high frequency ultrasound (2) after elastometry and (3) after laparoscopy.

Eligibility criteria: Inclusion Criteria:

* clinical decision to perform minilaparoscopic guided liver biopsy for the staging of liver disease including the assessment of the degree of fibrosis.

Exclusion Criteria:

* ascites
* decompensated liver disease
* esophageal varices
* other collateral circulations
* obstructive cholestasis
* severe heart insufficiency (NYHA III-IV)

Primary outcomes:
measure: Prospective Evaluation of Acoustic Radiation Force Impulse (ARFI) Elastography and High-Frequency B-Mode Ultrasound in Compensated Patients for the Diagnosis of Liver Fibrosis/Cirrhosis in Comparison to Mini-Laparoscopic Biopsy
timeFrame: blood tests, b-mode ultrasound, ARFI and minilaparoscopy to be done preferential within 48 hours
Secondary outcomes:
measure: Can the non invasive tests be combined resulting in a better accuracy for the prediction of liver cirrhosis/fibrosis?
timeFrame: blood tests, b-mode ultrasound, ARFI and minilaparoscopy to be done preferential within 48 hours
Other outcomes:
measure: What liver related complications develop and by which test are they best predicted?
timeFrame: Follow up patients for 3/5 years
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen Nürnberg
state: Bayern
Study officials:
affiliation: Universitätsklinikum Erlangen-Nürnberg
name: Deike Stobel, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06553313: Analysis of Protein Expression in Serum of KOA Subjects
Official title: Analysis of Protein Expression in Serum of Subjects With Knee Arthritis Control Group and Evaluation by Meridian and Pulse Wave Energy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In the previous study "Using omics technology to explore the mechanism of acupuncture treatment of different acupoints of knee osteoarthritis: a randomized controlled trial (CMUH109-REC3-113)", we found that acupuncture for knee osteoarthritis(KOA) significantly reduces inflammation, apoptosis, and metabolism-related serum protein profiles. However, due to the lack of serum protein data from the control group, it is impossible to establish standard values for comparison. To analyze the protein expression in the serum of KOA control group subjects, we also measured the spectral energy values of the radial artery pulse wave obtained from the pulse sphygmograph and the meridian energy values obtained from Ryodoraku. The results obtained can be compared with previous studies, thus this experiment was designed.


Eligibility criteria: Inclusion Criteria:

* Adults over 50 years old without knee pain

Exclusion Criteria:

1. Clinical diagnosis of knee osteoarthritis
2. Taking anti-inflammatory and analgesic drugs in the past month
3. Taking blood-lipid-lowering drugs or health foods in the past month
4. Received any acupuncture treatment in the past 3 weeks

Primary outcomes:
measure: Micro-Western Array and Enzyme-linked immunosorbent assay
timeFrame: the first and the fifth weeks
Secondary outcomes:
measure: pulse sphygmograph and Ryodoraku
timeFrame: the first and the fifth weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
affiliation: China Medical University, China
name: Wan-Zhen Yu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03818113: Clinical Comparative Analysis of Bretschneider and St. Thomas Cardioplegia Solution in Case of Mitral Valve Repair Via Anterolateral Right Thoracotomy
Official title: Clinical Comparative Analysis of Bretschneider and St. Thomas Cardioplegia Solution in Case of Mitral Valve Repair Via Anterolateral Right Thoracotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve Reconstruction
Keywords: mitral valve insufficiency
cardioplegia
cardioplegia Solution
HTK-Bretschneider (Custidiol®) solution
St. Thomas solution
cardiac biomarker
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with mitral valve reconstruction done via minimal invasive antero- lateral thoracotomy (2009-2018) at Universitätsspital Basel.

Brief summary: Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy is done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).

This study investigates HTK-Bretschneider versus St. Thomas cardioplegic solution regarding peri- and postoperative outcome, especially for cardiac biomarkers.


Eligibility criteria: Inclusion Criteria:

* Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).

Exclusion Criteria:

* Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with cardioplegic Solutions other than HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).

Primary outcomes:
measure: high specific troponin T (hs-TrT) (μg/l)
timeFrame: perioperative during minimal invasive surgery
measure: Creatin-Phosphokinase (CK) (U/l)
timeFrame: perioperative during minimal invasive surgery
measure: Creatinkinase Muscle- Brain (CK-MB) (U/l)
timeFrame: perioperative during minimal invasive surgery
Secondary outcomes:
measure: mortality rate
timeFrame: from minimal invasive surgery until 30 days post surgery
measure: length of stay in intensive care unit (days)
timeFrame: from minimal invasive surgery until 30 days post surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Klinik für Herzchirurgie, Universitätsspital Basel
Study officials:
affiliation: Klinik für Herzchirurgie, Universitätsspital Basel
name: Martin Grapow, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: