louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04291807: Video Assisted Education Before ERCP
Official title: Determining the Effect of Video Assisted Education on Anxiety Level and Satisfaction Before ERCP Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Compliance
Keywords: video education
ERCP
anxiety level
pain score
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: It was aimed to study the effect of video assisted education about endoscopic retrograde cholangiopancreaticography (ERCP) on anxiety levels of patients who planned to undergo ERCP for any reason.Video revealing the ERCP procedure was shown to the patients in one group and not shown to the other. Then anxiety levels and pain scores have been obtained before and after the procedure in both groups

Detailed description: The study was conducted to determine the effect of video education on anxiety level before the ERCP procedure and satisfaction degree after the ERCP procedure between September 1st 2017 and December 31st 2018 at Bagcilar Medipol Mega University Hospital. Patients were grouped into two in a randomized manner. In control arm, patients underwent ERCP procedure with the information provided by the gastroenterologist who recommended the procedure. Patients in experimental arm, besides the information provided by the gastroenterologist, watched video of ERCP procedure and answered all the questions about the procedure by an experienced nurse. A total of 70 patients (35 in each arms) was planned to enroll to the study. State-Trait Anxiety Inventory (STAI) form was applied to measure anxiety level and visual analog score (VAS) was applied to measure the satisfaction about the procedure.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Conscious enough to understand the procedure and education
* Patients who can read
* Hemodynamically stable patients
* Mentally stable patients
* Patients who gave informed consent

Exclusion Criteria:

* Patients who underwent previous ERCP procedure

Primary outcomes:
measure: Change in anxiety status of the patients after ERCP
timeFrame: an hour before ERCP and an hour after ERCP
Secondary outcomes:
measure: Satisfaction assessed by visual analogue scale
timeFrame: an hour after ERCP
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: Leyla Cevik, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Medipol University
name: Selda Rızalar, Assoc Prof
role: STUDY_CHAIR
References:
Clinical trial NCT02980107: Presenting Summary Information From Cochrane Systematic Reviews: Protocol for Research of Infographics Presentation vs. Plain Language Summary
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Lead sponsor: University Hospital of Split
Sponsor class: OTHER
Collaborators: name: University of Liverpool
First posted: 2016-12-02
Enrollment: 212
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy of infographics, compared to standard PLS format, in presenting information, in terms of understanding and remembering research results by consumers.

Detailed description: The investigators will conduct a randomized controlled trial (RCT) with two different formats of the same systematic review summary (Infographics, PLS). The content of these two formats is based on the same systematic review, but the ways of data presentation will differ: visual presentation in plain language and plain language only. The interventions will be delivered online in November 2016, with members of the consumers' groups for pregnancy and parenting - RODA ("Roditelji u akciji", engl."Parents in action"), which gathers different types of consumers: pregnant women, young mothers and parenting and pregnancy advisors; and the members of the Association for Patients' Rights. The trial will be voluntary and anonymous. The survey will consist of 5 parts, in the following order: 1) one format of the summary (randomly assigned), 2) health numeracy, 3) demographic data 4) comprehension test of the information given in the summary, and 5) user friendliness of information and overall satisfaction with the given summary assessed by survey.

Eligibility criteria: Inclusion Criteria:

* Eligible participants will be members of RODA and Association for Patients' Rights (women) .

Exclusion Criteria:

* Male members of RODA and Association for Patient's Rights

Primary outcomes:
measure: Understanding of the Summary Content
timeFrame: One month (30 days)
Secondary outcomes:
measure: Reading Experience
timeFrame: One month (30 days)
measure: User Friendliness
timeFrame: One month (30 days)
Other outcomes:
measure: Health Numeracy
timeFrame: One month (30 days)
Locations:
city: Split
country: Croatia
facility: University of Split
Study officials:
affiliation: Researcher
name: Ivan Buljan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Osborn CY, Wallston KA, Shpigel A, Cavanaugh K, Kripalani S, Rothman RL. Development and validation of the General Health Numeracy Test (GHNT). Patient Educ Couns. 2013 Jun;91(3):350-6. doi: 10.1016/j.pec.2013.01.001. Epub 2013 Feb 21.
Clinical trial NCT05472207: "Multifactorial Risk Stratification in Acute and Chronic Cardiovascular Disease"
Official title: "Multifactorial Risk Stratification in Acute and Chronic Cardiovascular Disease" ("riskINN ")
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Healthy
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 5000
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: Individuals suffering from an acute or chronic cardiovascular disease

Brief summary: The aim of this study is to develop risk prediction models for the early detection of high-risk patients with structural, rhythmological or inflammatory cardiovascular diseases.


Eligibility criteria: Inclusion Criteria:

* Decision-eligible male and female patients ≥18 years of age
* Acute or chronic condition due to structural, rhythmologic, or inflammatory cardiovascular disease
* Informed consent for participation in the clinical trial

Exclusion Criteria:

* missing infromed consent
* pregnant or breast-feeding women

Primary outcomes:
measure: combination of cardiovascular mortality, stroke, myocardial infarction and hospitalization due to decompensated heart failure
timeFrame: from inclusion to end of study (max. 4 years)
Secondary outcomes:
measure: total mortality
timeFrame: from inclusion to end of study (max. 4 years)
measure: cardiovascular mortality
timeFrame: from inclusion to end of study (max. 4 years)
measure: stroke
timeFrame: from inclusion to end of study (max. 4 years)
measure: myocardial infarction
timeFrame: from inclusion to end of study (max. 4 years)
measure: hospitalization due to decompensated heart failure
timeFrame: from inclusion to end of study (max. 4 years)
measure: hospitalization due to cardiovascular condition
timeFrame: from inclusion to end of study (max. 4 years)
measure: admission to intensive care unit
timeFrame: from inclusion to end of study (max. 4 years)
measure: severe arrythmic events
timeFrame: from inclusion to end of study (max. 4 years)
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III, Kardiologie & Angiologie
state: Tyrol
city: Münster
country: Austria
facility: Reha Zentrum Münster
state: Tyrol
Study officials:
References:
Clinical trial NCT02093507: Effectiveness of Parent's Manipulation in Newborn With Metatarsus Adducts. a Randomized Controlled Trial
Official title: Effectiveness of Parent's Manipulation in Newborn With Metatarsus Adducts.a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Foot Deformity Congenital
Keywords: newborn
foot deformity congenital
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-03-21
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the result of parent's feet manipulation compared with nonmanipulated group within first 6 months of life and observe spectrum of the disease within this period.

Detailed description: The newborn with metatarsus adducts are included in the study and divide in 2 groups by random.Group A with parents'manipulation of the foot and group B without manipulation of the foot.The parents'foot manipulation is trained by pediatric orthopedic surgeons to correct the deformity.The effectiveness of the manipulation is measured by percentage of no deformity of the foot in newborn after 6 months.

Eligibility criteria: Inclusion Criteria:

* newborn with Metatarsus adducts.

Exclusion Criteria:

* 1. criteria were included newborns with associated life threatening conditions. 2. congenital or musculoskeletal problems.(ie;arthrogryposis multiplex congenita,skeletal dysplasia) 3. mental retardation. 4. cognitive impairment. 5. parents incooperative. 6. difficult to follow up patients.

Primary outcomes:
measure: evidence of no foot deformity of newborn
timeFrame: 6 month
Secondary outcomes:
measure: the statistical significant difference between sex and duration from disease to cure
timeFrame: 6 month
Other outcomes:
measure: the satisfaction score
timeFrame: 6 month
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj hospoital
state: Bangkok
Study officials:
affiliation: Department of orthopaedic surgery,faculty of medicine Siriraj Hospital,Mahidol University,Banfkok,Thailand
name: Prof.Dr.Kamolporn - Kaewpornsawan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00168207: IL-7 Receptor Polymorphisms and Immune Recovery With HAART
Official title: The Relationship of Single Nucleotide Polymorphisms in the Interleukin-7 Receptor-α Gene to CD4+ Immune Recovery in HIV Infected Patients Who Begin Antiretroviral Treatment With HAART
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Treatment Experienced
HIV
Lead sponsor: The Alfred
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2005-09-15
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infected patients on HAART

Brief summary: The aim is to investigate the hypothesis that IL7-receptor polymorphisms contribute to the differential immune recovery of CD4 + T cells following HAART

Detailed description: AIM: To examine the association between the four haplotypes of IL-7Rα gene and a cohort of HIV infected patients who have commenced HAART with varying CD4+ T lymphocyte responses.

METHODS: IL-7Rα gene SNPs and haplotypes will be measured by constructing DNA pools, and PCR amplification and DNA sequencing. IL-7Rα expression will be examined using constitutive expression of IL-7Rα, IL-7Rα gene expression, and inducible expression of IL7Rα.

Eligibility criteria: Inclusion Criteria:

* Men or women at least 18 years of age
* First antiretroviral regimen composed of HAART as defined by at least three antiretrovirals
* Controlled viremia for a period of at least 12 months following commencement of HAART. Controlled viremia is defined as HIV viral load of ≤ 500 copies/mL on bDNA testing (versions 2 and 3) and \<400 copies/ml measured by RT-PCR assay by 6 months treatment.
* CD4 cell count \<500 at commencement of HAART
* Measurement of CD4+ cell count on at least 3 time points, in the 12 months post commencement of HAART.

Exclusion Criteria:

* Exclude patients treated for HIV seroconversion illness
* Exclude patients on immunomodulatory therapy such as IL-2, hydroxyurea or prednisolone or who have received an HIV therapeutic vaccine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital, Commercial Road
state: Victoria
Study officials:
affiliation: The Alfred
name: Jennifer Hoy, A/Prof
role: STUDY_DIRECTOR
affiliation: Alfred Hospital, Melbourne, Vic 3004
name: Sharon Lewin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00289107: Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA
Official title: Multi-center, Prospective, Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting vs P.F.C.® Sigma™ Cruciate Substituting Knee Primary Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Rheumatoid Arthritis
Other Inflammatory Arthritis
Post-Traumatic Arthritis
Juvenile Rheumatoid Arthritis
Avascular Necrosis
Keywords: Total Knee Replacement
Knee Prosthesis
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2006-02-09
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.

Detailed description: The study will evaluate the clinical performance of rotating platform and fixed bearing cruciate ligament substituting implants by obtaining a series of primary TKAS. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System or P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System and assignment is randomized.

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis
* Rheumatoid arthritis
* Other inflammatory arthritis
* Avascular necrosis (AVN) of bone
* Post-Traumatic Arthritis
* Juvenile Rheumatoid Arthritis

Exclusion Criteria:

* History of recent/active joint sepsis.
* Charcot neuropathy.
* Psycho-social disorders that would limit rehabilitation.
* Greater than 75 years of age at the time of surgery.
* Prior ipsilateral knee arthroplasty.
* Metabolic disorders of calcified tissues, such as Paget's disease.
* Severe diabetes mellitus.
* Joint replacement due to autoimmune disorders.
* Skeletal immaturity

Primary outcomes:
measure: Knee Society Score
timeFrame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Secondary outcomes:
measure: Complications
timeFrame: On-going to end of study
measure: Revisions
timeFrame: On-going to end of study
measure: Medical Imaging
timeFrame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
measure: SF-12 Patient Outcomes
timeFrame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Other outcomes:
Locations:
city: Greensboro
country: United States
state: North Carolina
city: Austin
country: United States
state: Texas
city: Lakewood
country: United States
state: Washington
Study officials:
affiliation: DePuy Orthopaedics
name: Tammy L O'Dell, EMT, CCRA
role: STUDY_DIRECTOR
References:
Clinical trial NCT04585607: Potential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia
Official title: Long-term Effects of Expanded Hemodialysis in Reduction of Large Middle Molecules in Chronic Hemodialysis Patients: Potential Benefits to the Prevention of Sarcopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 47
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participant hospital currently has around 90 maintenance HD patients and it is possible to recruit 74 patients for this study. Study subjects will be randomized to each treatment arm using a random number table. As outlined in the proposal, it is estimated that we may experience up to 30% of drop out during the study.
Primary purpose: TREATMENT

Brief summary: The current study will investigate whether long term implementation of expanded hemodialysis (HDx) will effectively decrease serum levels of large uremic toxins and ameliorate progression of sarcopenia in patients with chronic kidney disease requiring hemodialysis.

Detailed description: This is an open-label, prospective, 1:1 randomized, parallel-group, study to evaluate the efficacy of expanded hemodialysis (HDx) compared to conventional hemodialysis in patients with chronic kidney disease in South Korea for up to 12 months.

Eligibility criteria: Inclusion Criteria:

* On HD treatment over 6 months before study enrollment
* Aged over 18 years
* Able to give informed consent

Exclusion Criteria:

1. Hemiplegia or paraplegia state
2. Planned renal transplant or conversion to peritoneal dialysis within study period
3. Active chronic infection or inflammatory conditions including autoimmune disease, inflammatory arthritis and active malignancy
4. History of monoclonal gammopathy
5. Life expectancy \<12 months
6. Pregnancy or breast feeding
7. Receiving immunosuppressant medication
8. Inability to complete study assessments

Primary outcomes:
measure: Biomarkers of sarcopenia
timeFrame: Changes in serum level of Myostatin and IGF-1 every 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References:
Clinical trial NCT00043407: CPG 7909 in Patients Wih Stage IV Renal Cell Cancer
Official title: A Phase I/II, Open Label, Multi-Center Study For The Evaluation Of CPG 7909 In Patients With Stage Iv Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: Renal Cell Carcinoma, Phase I, Phase II, Immunotherapy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-08-12
Enrollment: 42
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: CPG 7909 given alone to patients with renal cell cancer after their nephrectomy. CPG 7909 is as a subcutaneous injection once per week for up to 24 weeks. Up to 40 patients will be included in the study.


Eligibility criteria: Inclusion Criteria:

Stage IV Renal Cell Carcinoma with lung and/or soft tissue metastasis Nephrectomy Measurable disease by RECIST criteria

Exclusion Criteria:

CNS, bone or Liver metastasis Tumors that are mainly papillary, chromophobe, medullary, collecting duct, or unclassified Prior immunotherapy, including IL-2 or IFN-alpha

Primary outcomes:
measure: To determine the tolerability of escalating doses of subcutaneously administered CPG 7909 Injection up to a maximum dose of 0.81 mg/kg in patients with metastatic renal cell cancer.
timeFrame: Indeterminate
measure: To establish the maximum tolerated dose for CPG 7909 Injection as monotherapy in patients with metastatic renal cell cancer up to a dose of 0.81mg/kg.
timeFrame: Indeterminate
measure: To estimate the overall tumor response rate of CpG 7909 according to the RECIST criteria in patients with metastatic renal cell cancer.
timeFrame: Indeterminate
Secondary outcomes:
measure: To assess tolerability relative to dose exposure, immunologic activity, the pharmacokinetic and pharmacodynamic profile of CPG 7909 Injection, time to progression, duration of response, and time to survival.
timeFrame: Indeterminate
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01408407: Alkagin Paste in the Prevention of Radiation Dermatitis
Official title: A Phase II Study Designed to Evaluate the Value of Alkagin Paste in the Prevention of Radiation Dermatitis for Patients Undergoing External Radiation Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Anus Neoplasms
Rectal Neoplasms
Urogenital Neoplasms
Keywords: Patients with anal canal, low rectal or gynecological cancer
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: Avario Healthcare Inc.
First posted: 2011-08-03
Enrollment: 2
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 determine whether Alkagin paste is effective at preventing radiodermatitis in patients receiving external beam radiation therapy to the perineal area.


Eligibility criteria: Inclusion Criteria:

* Patients receiving a dose of 45 Gy or more with concomitant chemotherapy to the perineal skin (for treatment of anal canal, low rectal or gynecological cancer).
* Patients able to understand and sign an informed consent form.
* Patients that do not have active connective tissue disorders.
* Patients 18 years or older.
* Patients that did not receive any previous radiation.
* Patients that do not have any known allergy to any ingredients of the Alkagin Paste
* Patients need to be able to apply the creams themselves or have help with applying the creams.
* Patients who have been offered to purchase silver clear underpants but have refused

Exclusion Criteria:

* Patients that have a type V or type VI skin type according to the Fitzpatrick scale (because these patients will likely have less radiodermatitis and if they do, it will be harder to evaluate it)

The Fitzpatrick Scale:

* Type I (scores 0-7) White; very fair; freckles. Always burns, never tans
* Type II (scores 8-16) White; fair. Usually burns, tans with difficulty
* Type III (scores 17-25) Beige; very common. Sometimes mild burn, gradually tans
* Type IV (scores 25-30) Beige with a brown tint; typical Mediterranean Caucasian skin. Rarely burns, tans with ease
* Type V (scores over 30) Dark brown. Very rarely burns, tans very easily
* Type VI Black. Never burns, tans very easily

  2) Patients with an allergic reaction to Alkagin Paste

Primary outcomes:
measure: Maximum skin toxicity
timeFrame: 7 weeks post beginning of radiation treatments
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Te Vuong, MD
role: PRINCIPAL_INVESTIGATOR
References: