louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03006094: The Greek Version of the Chronic Pain Grade Questionnaire (CPGQ)
Official title: Validity, Reliability and Responsiveness of the Greek Version of the Chronic Pain Grade Questionnaire (CPGQ) in Chronic Hip Pain Sufferers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hip Pain
Keywords: questionnaire
hip
pain
Lead sponsor: Asklepieion Voulas General Hospital
Sponsor class: OTHER_GOV
First posted: 2016-12-30
Enrollment: 87
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: Orthopaedic outpatients

Brief summary: The aim of the present study is to investigate and report on the psychometric properties of a Greek version of the Chronic Pain Grade Questionnaire (CPGQ).

Detailed description: The Chronic Pain Grade Questionnaire (CPGQ) is designed to evaluate overall severity of chronic pain based on two dimensions, pain intensity and pain-related disability. Currently, there is no reliable, valid and sensitive to change self-report instrument as brief and easy to understand and complete as the CPGQ available in Greek. A culturally adapted version of the CPGQ would facilitate the study of chronic pain and its implications in the Greek population and allow for cross-cultural comparisons. The aim of the present study is to examine the validity, reliability and responsiveness of a Greek version of the CPGQ in chronic hip pain sufferers.

Eligibility criteria: Inclusion Criteria:

* chronic hip pain (persistent or recurrent hip pain for at least 12 weeks)

Exclusion Criteria:

* severe systemic disease that is a constant threat to life
* known psychiatric disorder
* impaired cognition or dementia
* mother language other than Greek

Primary outcomes:
measure: Factor analysis of the Greek version of the CPGQ
timeFrame: At recruitment (baseline)
measure: Correlations between the CPGQ items, total, subscale scores and the SF-12 PCS, MCS scores
timeFrame: At recruitment (baseline)
measure: Cronbach's alpha values for the total scale and each subscale of the Greek version of the CPGQ
timeFrame: At recruitment (baseline)
measure: Intraclass correlation coefficient (ICC) values for the total scale and each sub scale of the Greek version of the CPGQ
timeFrame: 48 hours
measure: Change in CPGQ total scale and subscale scores
timeFrame: At recruitment (baseline) and 6 months following total hip replacement surgery
Secondary outcomes:
measure: Percentage of patients who were able to complete the Greek version of the CPGQ by themselves
timeFrame: At recruitment (baseline)
measure: Time employed in filling out the Greek version of the CPGQ
timeFrame: At recruitment (baseline)
Other outcomes:
Locations:
city: Voula
country: Greece
facility: General Hospital Asklepieio Voulas
Study officials:
References:
Clinical trial NCT00897494: Identification of Biomarkers for Early Detection of Pancreatic Cancer
Official title: Michigan Center for Pancreatic Cancer Molecular Diagnosis: The Serum Protein Microarray Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Venous blood collection samples from newly dianosed

Brief summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is examining blood samples from patients with cancer to identify biomarkers that may help in the early detection of pancreatic cancer.

Detailed description: OBJECTIVES:

* Identify specific proteins of interest to evaluate for their potential role as markers for pancreatic cancer.
* Analyze serum proteins directly by mass spectrometry to identify new biomarkers of pancreatic cancer that can be used for early diagnosis.

OUTLINE: Blood from patients is collected prior to treatment. Plasma proteins are analyzed by matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF/MS) and/or electrospray mass spectrometry (ESI/MS).

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of pancreatic cancer

  * Newly diagnosed disease
* Planning to undergo surgery or other treatment for pancreatic cancer at Karmanos Cancer Institute or its affiliates

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Identification of specific proteins of interest to evaluate for their potential role as markers for pancreatic cancer
timeFrame: Upon collection when patient agrees to provide a one time venous blood collection
measure: Analysis of serum proteins directly by mass spectrometry to identify new biomarkers of pancreatic cancer that can be used for early diagnosis
timeFrame: After separation from the plasma
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Fazlul Sarkar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00757094: Safety and Feasibility of Fasting While Receiving Chemotherapy
Official title: Safety and Feasibility of Fasting While Receiving Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasting
Chemotherapy
Cancer
Keywords: Fasting
Chemotherapy
Cancer
Lead sponsor: King Fahad Medical City
Sponsor class: OTHER_GOV
First posted: 2008-09-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fasting patients who are schedulled to receive chemotherapy during the month of Ramadan

Brief summary: Fasting (refraining from eating and drinking) during the day is safe while receiving chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Established diagnosis of cancer
* Signed informed consent
* Adequate CBC and chemistry to receive chemotherapy

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Safety of fasting while receiving chemotherapy
timeFrame: two months
Secondary outcomes:
measure: Effect of fasting on chemotherapy side effects
timeFrame: two months
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
Study officials:
affiliation: King Fahad Medical City
name: Ali SM Al-Shanqeeti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raffaghello L, Lee C, Safdie FM, Wei M, Madia F, Bianchi G, Longo VD. Starvation-dependent differential stress resistance protects normal but not cancer cells against high-dose chemotherapy. Proc Natl Acad Sci U S A. 2008 Jun 17;105(24):8215-20. doi: 10.1073/pnas.0708100105. Epub 2008 Mar 31.
citation: Weindruch R, Walford RL. Dietary restriction in mice beginning at 1 year of age: effect on life-span and spontaneous cancer incidence. Science. 1982 Mar 12;215(4538):1415-8. doi: 10.1126/science.7063854.
citation: Ross MH, Bras G. Lasting influence of early caloric restriction on prevalence of neoplasms in the rat. J Natl Cancer Inst. 1971 Nov;47(5):1095-113. No abstract available.
citation: Klurfeld DM, Welch CB, Lloyd LM, Kritchevsky D. Inhibition of DMBA-induced mammary tumorigenesis by caloric restriction in rats fed high-fat diets. Int J Cancer. 1989 May 15;43(5):922-5. doi: 10.1002/ijc.2910430532.
citation: Dirx MJ, Zeegers MP, Dagnelie PC, van den Bogaard T, van den Brandt PA. Energy restriction and the risk of spontaneous mammary tumors in mice: a meta-analysis. Int J Cancer. 2003 Sep 20;106(5):766-70. doi: 10.1002/ijc.11277.
Clinical trial NCT04446494: Identification and Preservation of Arm Lymphatics
Official title: Identification and Preservation of Arm Lymphatics (DEPART) in Axillary Dissection for Breast Cancer to Reduce Arm Lymphedema Events: A Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Related Lymphedema
Keywords: breast cancer
axillary lymph node dissection
lymphedema
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Controversy in axillary reverse mapping in axillary lymph node dissection (ALND) possibly results from incomplete recognition of the arm lymphatic system (ALS) and its compromise to oncological safety. The iDEntification and Preservation of ARm lymphaTics (DEPART) technique facilitates complete identification of ALS; therefore, its use may decrease the occurrence of arm lymphedema. This study aimed to examine the arm lymphedema rate, locoregional recurrence, and feasibility to perform DEPART in ALND.

In the study group, indocyanine green and methylene blue (MB) were utilized to identify arm sentinel nodes, and 0.1 ml MB was injected into the arm sentinel nodes to reveal the subsequent-echelon nodes and lymphatics. Gross arm lymph nodes were examined by intraoperative partial frozen section and were removed if positive. Arm lymphedema, local recurrence, regional recurrence, and distant metastasis were recorded at different follow-up examinations.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older with T1-3 invasive breast cancer;
* Clinically node-positive breast cancer, defined as positive on preoperative axillary palpation, ultrasound examination, and computed tomography scan with contrast;
* Patients who underwent mastectomy with a positive sentinel lymph node (SLN);
* Patients who underwent breast-conserving surgery containing more than two positive SLNs.

Exclusion Criteria:

* Neoadjuvant chemotherapy;
* Previous history of breast cancer.

Primary outcomes:
measure: Rate of arm lymphedema
timeFrame: Up to 2 years
Secondary outcomes:
measure: Rate of locoregional recurrence
timeFrame: 5-year estimate reported after a median follow-up of 60 months
measure: Rate of distant metastasis
timeFrame: 5-year estimate reported after a median follow-up of 60 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
References:
citation: Yuan Q, Wu G, Xiao SY, Hou J, Ren Y, Wang H, Wang K, Zhang D. Identification and Preservation of Arm Lymphatic System in Axillary Dissection for Breast Cancer to Reduce Arm Lymphedema Events: A Randomized Clinical Trial. Ann Surg Oncol. 2019 Oct;26(11):3446-3454. doi: 10.1245/s10434-019-07569-4. Epub 2019 Jun 25.
Clinical trial NCT03753594: Changes of Regional Tissue Oxygenation Saturation After Successful Femoral Nerve Block
Official title: Changes of Regional Tissue Oxygenation Saturation After Successful Femoral Nerve Block With Ropivacaine at Different Concentrations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Local
Keywords: Peripheral nerve block
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred adult patients scheduled for elective knee arthroscopy with peripheral nerve block

Brief summary: Regional tissue oxygenation saturation has been shown to increase in innervated regions after sympathetic block. The aim of this prospective observational study was to evaluate the changes of regional tissue oxygenation saturation by near-infrared spectroscopy after successful femoral nerve block with ropivacaine and determine whether the changes of regional tissue oxygenation saturation can be affected by the concentration of ropivacaine.

Detailed description: Successful peripheral nerve blocks induce sympathetic blockade, which increases local blood flow by vasodilation. The relationship between successful femoral nerve block and the variation of regional tissue oxygenation saturation was unclear.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* American Society of Anesthesiologists physical statusⅠ-Ⅱ
* Undergo elective elective knee arthroscopy with peripheral nerve block

Exclusion Criteria:

* Refusal to participate in the study
* BMI\>35
* Any contraindications to peripheral nerve block such as coagulation abnormalities, •Allergy to local anaesthetics, peripheral neuropathy

Primary outcomes:
measure: Regional tissue oxygenation saturation after successful femoral nerve block
timeFrame: at 5-minute intervals till 30 minutes after regional block
Secondary outcomes:
measure: Pinprick sensory scores
timeFrame: 5 minute before regional block and at 5-minute intervals till 30 minutes after regional block
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Xiangdong Chen, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04524494: Human Intestinal Amino Acid Absorption and the Role of a Local RAS
Official title: Human Intestinal Amino Acid Absorption and the Role of a Local (Renin)-Angiotensin System (RAS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renin-Angiotensin Aldosterone System (RAS)
Keywords: Renin Angiotensin System
Angiotensin Converting Enzyme 2 (ACE2)
Angiotensin II AT1 Receptor Blocker
ACE inhibitors
intestinal amino acid absorption
Lead sponsor: University Children's Hospital Basel
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undertaking a gastroscopy and / or colonoscopy for a medical indication

Brief summary: This study is to find out what role a local intestinal RAS (renin angiotensin system) plays in the context of amino acid absorption in the human intestinal tract and how this RAS and thus the amino acid absorption is influenced by the RAS-active drugs (angiotensin II AT1 receptor blockers (sartans) or ACE inhibitors).


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI): 18-35 kg/m2
* cohort 1: therapy with an angiotensin II AT1 antagonist or ACE Inhibitor
* cohort 2: no therapy with an angiotensin II AT1 antagonist or ACE Inhibitor
* Carrying out a diagnostic gastroscopy, colonoscopy or a combined gastroscopy / colonoscopy
* Existence of written consent after detailed information about the study

Exclusion Criteria:

* Severe pathological changes in the gastrointestinal tract (e.g. sprue, stomach ulcers, malignancies); (reflux esophagitis and gastritis are not Exclusion criteria)
* History of gastrointestinal tract surgery (except for appendectomy and inguinal hernia surgery)
* History of malignancy
* Severe acute and chronic organ diseases requiring treatment (e.g. kidney replacement therapy)
* Patients with an increased risk of bleeding (e.g. oral anticoagulation, coagulation disorders)
* Drug or alcohol abuse
* Mental impairment limiting the ability to meet all study requirements

Primary outcomes:
measure: messenger ribonucleic acid (mRNA) quantification in intestinal tissue biopsy
timeFrame: single time-point at baseline
measure: amino acid concentration in blood sample
timeFrame: single time-point at baseline
measure: amino acid concentration in urine sample
timeFrame: single time-point at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitäts-Kinderspital beider Basel (UKBB)
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
Study officials:
affiliation: Universitäts-Kinderspital beider Basel (UKBB)
name: Raphael N Vuille-dit-Bille, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01254994: The Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure
Official title: A Prospective Open Label Control Study to Evaluate the Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Failure
Keywords: hepatitis B
acute on chronic liver failure (ACHBLF)
entecavir
treatment
predicting
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 108
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: To evaluate therapeutic efficacy and predicting factors of entecavir for treating patients with acute on chronic hepatitis B liver failure (ACHBLF). A total of 108 patients with ACHBLF were allocated into either a treatment group (ETV group, n=53) or a control group (n=55). The HBV DNA level, liver function and survival condition of the patients were observed for 48 weeks after enrollment. The factors possibly related to entecavir treatment efficacy were also identified.


Eligibility criteria: Inclusion Criteria:

* ACHBLF was diagnosed according to the criteria from the APASL in March 200815 and the program of Prevention and Cure for Viral Hepatitis and Liver Disease amended by the National Symposium on Viral Hepatitis and Liver Disease in September 2000.
* age \>18 years
* HBV DNA \> 3log10 copy/mL

Exclusion Criteria:

* Pregnant or lactating women.
* Diagnosed or suspected as hepatic carcinoma patients.
* Cases with any serious disease besides CHB, including heart disease, immunologic disease, malignant tumor, etc.
* Patients hypersensitive to nucleoside or nucleoside (acid) analogues or with a history nucleoside antiviral drug treatment.
* A history of drug abuse or alcohol abuse.
* Hepatic encephalopathy degree IV patients who were unable to take orally administered drugs.
* A history of using immunomodulator including steroids
* Conclusive evidence of other co infection s: anti-HAV-IgM positive, anti-HCV positive, anti-HEV positive, anti-HIV positive, autoimmunity liver diseases, Wilson disease, etc.

Primary outcomes:
measure: HBV DNA level and liver function
timeFrame: 48 weeks
Secondary outcomes:
measure: Symptoms,signs and mortality
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Lin B Liang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01375894: Body Movement Imitation and Perspective Perception Among Psychiatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Depression
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2011-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The ability to understand the other's perspective and respond accordingly is the most important normal process of daily social life and is probably one of the foundations of human existence. This capability is reflected, inter alia, as an imitation - an important and effective form of learning which is very developed in humans. When we are required to imitate a particular movement, speed of response depends on the perspective of the movement. Imitative response is implemented faster when the movement is observed from first-person perspective, than if the motion is presented from the perspective of a third party.

While healthy individuals don't find it difficult to imitate, or to understand the other's emotion expression, there are psychiatric populations (such as autism and schizophrenia) who find it difficult to demonstrate these capabilities (Park, Matthews et al. 2008). Beyond these capabilities impairment, schizophrenic patients have difficulty distinguishing between their arm movements and those of a foreign hand and find it difficult to leave the boundaries of egocentric interpretation of reality and adopt the other's point of view. These behavioral disorders arise from defects in the network of mirror neurons (Buccino and Amore 2008; Langdon, Coltheart et al. 2010).

Therefore, the investigator expect that schizophrenic patients will not see a preference for movements that will be displayed in first-person perspective from the same movements that will be displayed from the perspective of a third party. Consequently, the investigator speculate that these subjects will not exhibit differences at imitating the response of which will be presented from different perspectives (Jackson, Meltzoff et (al. 2006.


Eligibility criteria: Inclusion Criteria:

1. Men and women aged 20-65.
2. Subjects who met the criteria for diagnosis of major DSM-IV for schizophrenia or unipolar depression.
3. Subjects with normal or corrected vision.
4. Subjects who sign informed consent for their participation in the experiment

Exclusion Criteria:

1. Patients with acute disorder, or an unstable patient. Especially neurological disorders or head injuries.
2. Drug Abuse in the past year.
3. Lack of jurisdiction, such as people with mental retardation or dementia.
4. assessed with high suicide risk.
5. patients which are Compulsory hospitalized.
6. Pregnant women

Primary outcomes:
measure: speed of hand movement according to the reaction glove
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Hod hasharon
country: Israel
facility: Shalvata MHC
Study officials:
References: