louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04625920: A Virtual Reality System for Pain and Anxiety Management During Outpatient Hysteroscopy
Official title: A Virtual Reality System for Pain and Anxiety Management During Outpatient Hysteroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Vaginal Blood Loss
Keywords: Hysteroscopy
VR
Vurtual reality
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-11-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during operative hysteroscopy in the outpatient setting.

Detailed description: A prospective, open-label, randomized control trial in a tertiary university-affiliated medical center between April to August 2020. Overall, 100 women will be randomly allocated to undergo operative hysteroscopy either with the use of VR (study group) or with standard treatment (control group). The primary outcome measures includ self-reported pain, anxiety scores, and vital parameters as pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes were measured as numeric rating scores.

Eligibility criteria: Inclusion Criteria:

* . Women with suspected infection
* women considered not suitable to undergo an office hysteroscopy
* women who reported the use of analgesia 6 hours prior to the procedure.

Exclusion Criteria:

* patient needed office hysteroscopy

Primary outcomes:
measure: Assessments of pain through physiological parameters
timeFrame: 10 minutes
measure: Assessments of pain through pain score parameter
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
city: Tel Aviv
country: Israel
facility: Souraski MC
Study officials:
affiliation: souraski MC
name: eli shprecher, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT01574820: Role of Rosiglitazone on Pre-Diabetes Mellitus and Coronary Artery Disease
Official title: Role of Rosiglitazone Treatment and Secondary Prevention of Cardiovascular Events in Patients With Pre-Diabetes Mellitus and Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prediabetes
Coronary Artery Disease
Insulin Resistance
Glucose Intolerance
Keywords: prediabetes
coronary artery disease
insulin resistance
glucose intolerance
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 105
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: TREATMENT

Brief summary: Objectives:

The investigators examined whether rosiglitazone, a thiazolidinedione (TZD), is beneficial for pre-diabetes mellitus (DM) adults with documented coronary artery disease (CAD).

Background:

Microvascular and macrovascular complications are common in type 2 DM. There is no evidence about the effects of TZDs, synthetic peroxisome proliferator-activated receptor (PPAR)-γ activators (insulin sensitizers and adipose transcriptional regulation and anti-inflammatory process activators) on pre-DM patients with documented CAD.

Detailed description: Materials and Methods:

This is a randomized, double-blind, placebo-controlled study, patients will be randomly assigned to the TZD group and to the placebo group with a 6-month treatment period.

Biomarkers will also examined before and 6 months post-treatment during the trial.

The primary end-points will be the diagnosis of major cardiovascular events: myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD.

Eligibility criteria: Inclusion Criteria:

* documented CAD by angiography
* insulin resistance or glucose intolerance
* 18 to 80 years of age

Exclusion Criteria:

* under DM treatment
* allergy to TZD
* active inflammation
* chronic disease under NSAID treatment
* active heart failure
* unwilling or unable to sign inform consents

Primary outcomes:
measure: major cardiovascular events, including myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD
timeFrame: at least 6 months follow-up of MACEs
Secondary outcomes:
measure: Biomarkers measurements
timeFrame: Biomarkers were taken before the trial and 6 months later
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01061320: Efficacy of Alpha Tocopherol for Prevention of Contrast-induced Nephropathy in Chronic Kidney Disease (CKD) Patients
Official title: Efficacy of Alpha Tocopherol and New Biomarker (Urine NGAL) for Prevention and Early Diagnosis of Contrast-induced Nephropathy in CKD Patients Undergoing Elective Coronary Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Contrast Induced Nephropathy
Keywords: Alpha-Tocopherol (Vitamin E)
Contrast induced nephropathy
Chronic kidney disease
Coronary procedures
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2010-02-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to demonstrate the efficacy of alpha tocopherol for prevention contrast-induced nephropathy in CKD patients undergoing elective coronary procedures.

Detailed description: Contrast-induced nephropathy (CIN) increases the likelihood of patient morbidity and mortality following coronary procedures. Contrast agents cause an acute deterioration in renal function via the generation of reactive oxygen species. Vitamin E (alpha tocopherol)was demonstrated to be anti-oxidant and anti-inflammation. The present study was designed to evaluate the administration of antioxidant vitamin E (alpha tocopherol) as a means of preventing CIN in these patients.

Eligibility criteria: Inclusion Criteria:

* serum creatinine levels \> 1.2 mg/dL and baseline creatinine clearance levels \< 60 mL/min (as measured in their most recent sample,drawn within 2 months prior to the beginning of the study)

Exclusion Criteria:

* patients with acute kidney injury
* end stage renal disease (requiring dialysis)
* unstable renal function (as evidenced by a change in serum creatinine of \> 0.5 mg/dL, or \> 25%, within 14 days prior to the study)
* allergy to any of the contrast agents
* mechanical ventilation
* suffered from congestive heart failure, cardiogenic shock or emergent angiography.
* receiving NAC, mannitol, diuretics, theophylline, dopamine, vitamin E or contrast agents within 14 days before the study

Primary outcomes:
measure: The primary end-point of this study is the development of CIN in placebo group compared with alpha tocopherol group.
timeFrame: 1 year
Secondary outcomes:
measure: The secondary end-point of this study is compare urine NGAL level in CIN patients between both groups.
timeFrame: 1 year
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Adis Tasanarong
state: Pathumtani
Study officials:
affiliation: Faculty of Medicine, Thammasat University (Rangsit Campus)
name: Adis Tasanarong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tasanarong A, Piyayotai D, Thitiarchakul S. Protection of radiocontrast induced nephropathy by vitamin E (alpha tocopherol): a randomized controlled pilot study. J Med Assoc Thai. 2009 Oct;92(10):1273-81.
Clinical trial NCT01119820: Tissue Donation for Myoblast Culture
Official title: Tissue Donation for Myoblast Culture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Observe in Vitro Characteristics of Muscle Tissue
Elective Obstetric or Gynecologic Surgery
Keywords: elective obstetric or gynecologic surgery
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2010-05-10
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Analyze human skeletal muscle and learn more about the ability of adult muscle to produce myoblasts (young muscle cells).

Detailed description: Study the ability of healthy human skeletal muscle to produce myoblasts, and to determine how many cells would be needed to regenerate a certain section of injured muscle. As part of this research, we hope to gain a better understanding of the effect of age on muscle and how normal skeletal muscle can regenerate itself by producing myoblasts. The information gathered from this study will be specifically used in future research for treating Anal Incontinence.

Eligibility criteria: Inclusion Criteria:

- Age: 18 years of age or older Female Patients who are already electing to undergo obstetric or gynecologic surgery (either vaginal or abdominal) for a preexisting condition.

Exclusion Criteria:

- Active systemic or pelvic infections including HIV HBV HCV, STD, PID Patients with tumors, metastatic disease or treated with cytostatics Patients undergoing emergency surgical procedures Unconscious or mentally incapable to consent

Primary outcomes:
measure: cell expansion
timeFrame: weekly
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: UCI Women's Healthcare
state: California
Study officials:
affiliation: UCI Medical Center
name: Felicia Lane, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03060720: Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy
Official title: Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-02-23
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient seen at Dana Farber Cancer Institute with a diagnosis of pancreatic ductal adenocarcinoma

Brief summary: This research study is looking at people with cancer of the pancreas to find clinical factors that can explain the presence of genetic mutations

Detailed description: This research is being done to identify which pancreatic cancer patients should undergo genetic evaluation. A patient's personal and family history of cancer is the information typically used to make this decision, but there are currently no accurate, evidence-based guidelines that exist to help doctors use this information to make a decision.

The investigators hope that by testing all new pancreatic cancer patients, they can determine which clinical factors predict for genetic mutations in order to create a risk assessment tool.

The investigators want to determine which patients with pancreatic cancer will benefit from genetic testing. To do so, the investigators will offer all patients with pancreatic cancer in the Dana-Farber Gastrointestinal Oncology clinic referral for genetic evaluation. At the Cancer Genetics and Prevention clinic appointment, the provider will review the patient's personal and familial history of cancer and offer genetic testing.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of pancreatic ductal adenocarcinoma
* Signed initial informed consent
* Participant agrees to genetic counseling

Exclusion Criteria:

* Prospective participant unable to sign informed consent based on referring physician recommendation.
* Patient has neuroendocrine pancreatic tumor

Primary outcomes:
measure: We will measure clinical factors (e.g. # of PDAC patients with a personal history of x,y,z; # of PDAC patients with a family history of x,y,z; # PDAC patients with a germline mutation in x,y,z) so as to develop a risk assessment tool
timeFrame: Up to 5 years
Secondary outcomes:
measure: Evaluate Patient Experience With Genetic Testing
timeFrame: up to 5 years
measure: Summarize patient satisfaction with Genetic counseling
timeFrame: up to 5 years
measure: Number of patients who disclose genetic testing results to relatives
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Matthew B Yurgelun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00364520: Molecular Epidemiology of Benzene-exposed Workers.
Official title: Molecular Epidemiology of Benzene-exposed Workers in Shanghai,China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Diseases
Keywords: Hematologic Diseases
Benzene
Genetic Polymorphisms
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Fudan University
name: University of Cincinnati
name: ExxonMobil Biomedical Sciences, Inc.
name: British Petroleum P.L.C.
name: Chevron Corporation
name: ConocoPhillips
name: Exxon Mobil
name: Marathon Ashland
name: Shell Chemicals
First posted: 2006-08-15
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Shanghai Workers

Brief summary: The purpose of this study is to investigate the health effects of benzene exposure in workers in Shanghai, China.

Detailed description: The purpose of this study is to investigate the dose-response relationship between benzene exposure and blood diseases in Shanghai workers and to characterize genetic polymorphisms that are associated with increased risk of developing benzene hematotoxicity.

Eligibility criteria: Inclusion Criteria:

Worked for at least one year in a monitored environment Have at least one physical examination recorded

-

Exclusion Criteria:

History of cancer, radiation exposure, chemotherapy

-

Primary outcomes:
measure: Investigate the dose-response relationship between benzene exposure and blood diseases in Shanghai workers.
timeFrame: August 2003 - December 2009
Secondary outcomes:
measure: Characterize genetic polymorphisms that are associated with increased risk of developing benzene hematotoxicity.
timeFrame: August 2003 - December 2009
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Joint Sino-US Clinical and Molecular Laboratory (JCML)
Study officials:
affiliation: University of Colorado at Denver and Health Sciences Ctr
name: Richard D Irons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01758120: Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy
Official title: A Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: IgA Nephropathy
Keywords: IgA nephropathy
Cyclophosphamide
prednisone
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone alone in patients with advanced-stage IgA nephropathy.


Eligibility criteria: Inclusion Criteria:

* biopsy-proven primary IgA nephropathy;
* 18-70 years old;
* elevated serum Creatinine and less than 3.0mg/dl;
* with a written consent from participants to receive prednisone and/or cyclophosphamide

Exclusion Criteria:

* diabetes;
* contraindications for the treatment of prednisone and/or cyclophosphamide;
* any treatment with steroids or immunosuppressive drugs prior to this study;
* acute deterioration of renal function(including those of glomerular origin)

Primary outcomes:
measure: the changes of kidney function or death
timeFrame: 3,6 ,12, 24 and 36 months or more after treatment
Secondary outcomes:
measure: the changes of proteinuria
timeFrame: 3,6 ,12, 24 and 36 months or more after treatment
Other outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 1,3,6 ,12, 24 and 36 months or more after treatment
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: wei shi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03683420: Music in Reducing Distress in Participants with Cancer During Chemotherapy Treatment
Official title: Using Music As a Tool for Distress Reduction During Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver
Malignant Neoplasm
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial studies how well music works in reducing distress in participants with cancer during chemotherapy treatment. Music in participants receiving cancer treatment such as infusion treatment and caregiver may reduce pain, anxiety, and distress and improve participant's psychological and physiological wellbeing.

Detailed description: PRIMARY OBJECTIVES:

I. To test the effect of patients? listening to music on level of distress during cancer treatment.

SECONDARY OBJECTIVES:

I. To explore the influence of covariates (patients? sociodemographics, musical background, and clinical variables) on the association between patients? listening to music and level of distress during cancer treatment.

II. To explore the interdependence of adjustment among patients and their caregivers on the association between.

OUTLINE: Participants and caregivers are randomized to 1 of 2 groups.

GROUP I: Participants and caregivers listen to music of their choice for up to 60 minutes during infusion session.

GROUP II: Participants and caregivers do not listen to music during infusion session and are placed on music waitlist.

Eligibility criteria: Inclusion Criteria:

* Able to speak, read, write and understand English
* Have sufficient hearing capacity to hear music

Exclusion Criteria:

* Patients with cognitive or perceptual disturbances will be excluded

Primary outcomes:
measure: Changes in pain assessed by Visual Analogue Scale
timeFrame: 1 hour
measure: Changes in mood assessed by Positive and Negative Affect Scale
timeFrame: 1 hour
measure: Changes in distress assessed by Distress Thermometer.
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University/Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Felicity Harper
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00697320: Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany
Official title: Efficacy of NovoSeven® (Activated Recombinant Human Factor VII): Non-interventional Study in Patients With Congenital Haemophilia With Inhibitors, Acquired Haemophilia, Factor FVII Deficiency, and Glanzmann's Thrombasthenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Bleeding Disorder
Congenital FVII Deficiency
Glanzmann's Disease
Acquired Bleeding Disorder
Acquired Haemophilia
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven®.

Brief summary: This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. The observational study observes patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained from patient or patient's legally acceptable representative in which he agrees that the patient's pseudonymised personal data will be transferred for use in a scientific evaluation and publication

Exclusion Criteria:

* Due to the non-interventional observational character of the study, there are no exclusion criteria.

Primary outcomes:
measure: Proportion of acute bleeding episodes for which haemostasis (defined as stop or significant reduction of bleeding) will be achieved
timeFrame: within 9 hours after initiation of treatment with NovoSeven® or of invasive procedures for which haemostasis will be maintained during the time period of haemostatic coverage with NovoSeven®
Secondary outcomes:
measure: Time proportion of acute bleeding treatments resulting in effective pain relief
timeFrame: within 9 hours after initiation of treatment with NovoSeven®
measure: Proportion of patients experiencing one or more re-bleeds
timeFrame: within 24 hours after begin of an acute bleeding episode that was successfully treated with NovoSeven® (stop or significant reduction of bleeding)
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: