louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02474433: Same-day Cervical Preparation With Misoprostol Before Hysteroscopy
Official title: Same-day Cervical Preparation With Misoprostol Before Hysteroscopy: a Randomized Trial of Different Routes of Administration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cervical Preparation Prior to Hysteroscopy
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-06-17
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized trial, assessing Misoprostol efficacy in cervical preparation several hours prior to hysteroscopy, comparing the different routes of administration (PO/PV/buccal). Initial cervical dilatation will be assessed, as well as surgical ease of dilatation, time required to achieve dilatation and patient preference.


Eligibility criteria: Inclusion Criteria:

* Patients admitted for elective hysteroscopy (diagnostic/surgical) at Wolfson Medical Center
* Written consent supplied

Exclusion Criteria:

* Contraindications to prostaglandin treatment (severe asthma, glaucoma, severe cardiac disease, renal failure)
* Prostaglandin allergy
* Pregnancy
* Genital infection
* Space-occupying lesion in the endocervical canal
* Prior cervical surgery

Primary outcomes:
measure: Preoperative cervical width in centimeters
timeFrame: intraoperative
Secondary outcomes:
measure: Time required to achieve cervical dilatation
timeFrame: intraoperative
measure: Ease of cervical dilatation
timeFrame: intraoperative
measure: Patient preference
timeFrame: baseline
measure: Adverse effects of medication
timeFrame: baseline
measure: Surgical complications
timeFrame: intraoperative
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
Study officials:
References:
citation: Ganer Herman H, Kerner R, Gluck O, Feit H, Keidar R, Bar J, Sagiv R. Different Routes of Misoprostol for Same-Day Cervical Priming Prior to Operative Hysteroscopy: A Randomized Blinded Trial. J Minim Invasive Gynecol. 2017 Mar-Apr;24(3):455-460. doi: 10.1016/j.jmig.2016.12.024. Epub 2017 Jan 7.
Clinical trial NCT02534233: Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium
Official title: Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett's Esophagus
Esophageal Squamous Dysplasia
Esophageal Cancer
Keywords: barrett's esophagus with dysplasia
early esophageal cancer
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Pentax Medical
First posted: 2015-08-27
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assess Cryoablation (CryoBalloon Ablation cryotherapy) for treatment of Dysplastic Barrett's Esophagus, Esophageal Squamous Dysplasia and early Esophageal Cancer. The cryoablation treatment will be offered as an alternative to standard ablation therapies such as Radiofrequency Ablation, Argon Plasma Coagulation and carbon dioxide Cryotherapy).

Detailed description: Cryoablation (cryotherapy) is an established type of mucosal ablation for treatment of various conditions in the GI tract, including Barrett's esophagus and esophageal cancer. The purpose of this study is to assess the safety, feasibility and performance of cryoablation system (the C2 Focal Cryoablation Device in patients with BE and esophageal squamous dysplasia who need ablation therapy for clinical standard care. The new cryoablation treatment will be offered as an alternative to standard ablation therapies already in place (radiofrequency ablation, carbon dioxide cryotherapy).

Eligibility criteria: Inclusion Criteria:

* Patients recommended for ablation of either Barrett's esophagus with dysplasia or esophageal squamous dysplasia, scheduled for upper endoscopy.

Exclusion Criteria:

* Patient unable to undergo endoscopy,
* Patients with visible esophageal mass.

Primary outcomes:
measure: Histological evaluation of treatment zone(s) for dysplasia
timeFrame: 60 months
measure: Number of patients with treatment-related adverse events (pain and dysphagia)
timeFrame: 60 months
Secondary outcomes:
measure: Histological evaluation of treatment zone for intestinal metaplasia (BE patients)
timeFrame: 60 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Marcia Canto, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Canto MI, Shaheen NJ, Almario JA, Voltaggio L, Montgomery E, Lightdale CJ. Multifocal nitrous oxide cryoballoon ablation with or without EMR for treatment of neoplastic Barrett's esophagus (with video). Gastrointest Endosc. 2018 Sep;88(3):438-446.e2. doi: 10.1016/j.gie.2018.03.024. Epub 2018 Apr 5.
Clinical trial NCT06486233: Studying the Effectiveness of Early Invasive Treatment in Elderly Patients With High-risk Non-ST-segment Elevation Acute Coronary Syndrome.
Official title: Comparison of Mortality and Complication Rates (Re-myocardial Infarction, Heart Failure, Re-hospitalization, Stroke) After 12 Months Between Two Groups of Patients Undergoing Early Invasive and Late Invasive Strategies in Patients With Elderly Patients With High - Risk Non-ST-segment Elevation Acute Coronary Syndrome.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction
Keywords: percutaneous coronary intervention, elderly, non-ST-segment Elevation
Lead sponsor: Gia Dinh People Hospital
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 385
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients aged 60 years and older were diagnosed with non-ST elevation acute coronary syndrome. Diagnosed with high-risk acute non-ST elevation syndrome and treated at Gia Dinh People's Hospital, Thong Nhat Hospital during the study period.

Brief summary: The goal of this is observational study is to compare about MACE events and predisposing factors related to MACE events in elderly patients with high-risk non-ST acute coronary syndromes receiving early versus late invasive treatment . This study will anwser two questions.

Question 1: What will factors associate with implementing a late invasive strategy in elderly patients with high-risk non-ST-segment elevation acute coronary syndrome ? Question 2: Is a meaningful difference about mortality and complication rates as re-myocardial infarction, heart failure, re-hospitalization, stroke after 12 months between two groups of patients undergoing early invasive and late invasive strategies in elderly patients with in high-risk non-ST-segment elevation acute coronary syndrome?


Eligibility criteria: Inclusion Criteria:

* aged 60 years and older
* high - risk non-ST-segment elevation acute coronary syndrome (according to the 2023 European Heart Association recommended standards).
* receives reperfusion intervention.

Exclusion Criteria:

* Acute coronary syndrome due to stent thrombosis, or coronary artery bypass graft occlusion.
* Incomplete medical records.

Primary outcomes:
measure: In-hospital death
timeFrame: one month
Secondary outcomes:
measure: after 12 months death
timeFrame: one year
measure: MACE after 12 months include re-admission, recurrent myocardial infarction , stroke, heart failure
timeFrame: one year
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Gia Dinh people hospital
Study officials:
References:
Clinical trial NCT02044133: Monocentric Randomized Study, Assessing the Interests of the Determination of Vitamin D in Prison Population. (Vitamine D)
Official title: Monocentric Randomized Study, Assessing the Interests of the Determination of Vitamin D in Prison Population. (Vitamine D)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Prisoner
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will be proposed to man entering the prison of La Roche sur Yon. Participants will be randomized into two arms: one arm realize a dosage of vitamin D at the entrance and 6 months after the entry and the second arm will carry only a dosage six months after entry.

the purpose of the study is to determine the interest of dosage of vitamin D in biological assessment of entry into prison house.


Eligibility criteria: Inclusion Criteria:

* Incarcerated person
* Imprisoned in La Roche sur Yon
* Male
* Age \> 18 year old
* Not opposed to participation in the study

Exclusion Criteria:

* Intellectual deficit not to understand the study
* Taking osteoporosis treatment or any other affecting the metabolism of vitamin D
* Renal failure, liver failure
* Hypercalcemia
* Thyroid dysfunction, parathyroid diseases
* Duration of imprisonment less than the expected duration of the study.
* Incarcerated person who had received supplementation of vitamin D in the 6 months prior

Primary outcomes:
measure: dosage of vitamin D
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: Centre hospitalier départemental Vendée
Study officials:
affiliation: CHD Vendée La Roche sur Yon
name: Yves BLEHER, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05152433: Evidence-Based Robot-Assistant in Neurorehabilitation
Official title: E-BRAiN - Evidence-Based Robot-Assistant in Neurorehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Paresis
Neglect, Hemispatial
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: BDH-Klinik Greifswald
First posted: 2021-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy, acceptability, and safety of the therapeutic system E-BRAiN for the treatment of stroke-related impairments.

Detailed description: This randomized controlled trial, RCT with cross-over design sequentially allocates participants with stroke-related impairment to both a two week course of conventional rehabilitation therapy and a two week course of therapy using the therapy system E-BRAiN (purpose-built therapy system using a socially interactive humanoid robot); participants are randomly allocated to the sequences "conventional =\> robot" or "robot =\> conventional". Stroke survivors with one of the target syndromes, i.e. mild arm paresis, or moderate to severe arm paresis, or visuospatial neglect are invited to participate.

Eligibility criteria: Inclusion Criteria:

* Age at study entry ≥ 18 years
* Stroke (ischemic stroke, non-traumatic intracerebral haemorrhage, subarachnoidal haemorrhage)
* Incomplete arm paresis (Motricity Index, arm score \>1 \[Min\] and \< 100 \[Max\]) or
* Visuospatial neglect (clinical signs and NET subtest "star cancellation" score \< 50)
* Candidate able to consent and provides informed consent or
* legal representative provides informed consent

Exclusion Criteria:

* Pregnant or breast feeding
* Obliged to live in an institution by law or public authority
* With case presentation arm paresis: another condition that causes arm paresis is present
* With case presentation visuospatial neglect: another condition that causes a relevant visual-perceptual deficit that cannot be compensated is present; exception: homonymous visual field deficits are not an exclusion criterion

Primary outcomes:
measure: Change scores over two weeks for the standardised primary outcome measure
timeFrame: 2 weeks
Secondary outcomes:
measure: Drop-out rate
timeFrame: 2 weeks
measure: Goal attainment
timeFrame: 2 weeks
measure: Change scores over two weeks for "Motivation for therapy"
timeFrame: 2 weeks
measure: Change scores over two weeks for "Emotional distress"
timeFrame: 2 weeks
measure: Work alliance
timeFrame: 2 weeks
measure: Adverse events
timeFrame: 2 weeks
Other outcomes:
measure: Type and frequency of neurorehabilitation therapy received
timeFrame: 2 weeks
Locations:
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Greifswald
country: Germany
facility: BDH-Klinik Greifswald
Study officials:
affiliation: Head, Neurorehabilitation Research Group
name: Thomas Platz, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02662933: Investigating the Relationship Between Physical Function, Comorbidity and Cytogenetic Risk Group in Older Adults With Acute Myelogenous Leukemia (AML)
Official title: Investigating the Relationship Between Physical Function, Comorbidity and Cytogenetic Risk Group in Older Adults With Acute Myelogenous Leukemia (AML)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACUTE MYELOGENOUS LEUKEMIA
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 82
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: AML is a disease of older adults, with a median age at diagnosis of 67 years . An estimated 13,410 new cases of AML will be diagnosed in 2007. Survival for AML is age-dependent, with significantly lower survival rates reported for older adults. SEER statistics from 1996-2003 show a 5 year relative survival rate of 34.4% for adults younger than 65 and 4.3% for those ≥65 years of age 1. Clinical trials have demonstrated worse survival outcomes in older adults with AML using age cutoffs of 55, 60 and 65 years. Older adults have also experienced increased toxicity to standard therapies in clinical trials. Chronologic age cutoffs have therefore been used in research and clinical practice due to concerns regarding toxicity associated with treatment. The reasons for the increased toxicity and decreased survival in older adults with AML is incompletely understood and likely multifactorial including both tumor specific and host specific factors. Improving understanding of which measurable clinical characteristics predict vulnerability to toxicity will help refine the research and clinical approach to older adults with AML.


Eligibility criteria: Inclusion Criteria:

* Capacity to provide signed protocol specific informed consent
* Age ≥ 60 years
* Pathologically confirmed newly diagnosed AML or undergoing workup for suspected AML
* Planned induction chemotherapy
* Inpatient status

Exclusion Criteria:

* Requiring intensive care unit support during initial evaluation
* Prior therapy for AML
* ECOG score \>3

Primary outcomes:
measure: Overall Survival
timeFrame: 27 months
Secondary outcomes:
measure: Treatment Related Mortality
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Heidi Klepin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01474733: Effects of a Longitudinal Health Literacy Training Program on Family Medicine Residents
Official title: Effects of a Longitudinal Health Literacy Training Program on Family Medicine Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Literacy
Keywords: resident education
health literacy
curriculum
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2011-11-18
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 1. Briefly describe the purpose of this protocol: This study is designed to evaluate the effectiveness of an educational training program on the topic of health literacy for Family Medicine residents. The hypothesis being tested is that training residents about health literacy will result in improvements in residents' knowledge, skills, and attitudes with respect to health literacy.
2. Briefly summarize how participants are recruited: OHSU Family Medicine Interns attending mandatory trainings on the topic of health literacy throughout the three years of the residency program will be invited to participate in the study.
3. Briefly describe the procedures subjects will undergo: Completion of a short self-administered anonymous survey before and after a variety of learning sessions on the topic of health literacy.
4. If applicable, briefly describe survey/interview instruments used: A 12-item pre-test questionnaire and 13-item post-test questionnaire designed to assess individuals' knowledge about health literacy, and intended clinical practices with respect to health literacy.
5. If this is a clinical trial using an experimental drug and/or device, or an approved drug and/or device used for an unapproved purpose, briefly describe the drug and/or device: n/a
6. Briefly describe how the data will be analyzed to address the purpose of the protocol: Demographics and responses to individual items will be reported as frequencies and percentages within the sample. We will use a chi-square analysis to stratify responses by demographic groups and t-tests to measure possible changes over time


Eligibility criteria: Inclusion Criteria:

-Family medicine resident entering in summer 2011 at OHSU Department of Family Medicine

Primary outcomes:
measure: knowledge about health literacy
timeFrame: 3 years
Secondary outcomes:
measure: clear communication skills
timeFrame: 3 years
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Richmond Clinic
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Clifford A Coleman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00777933: Randomized Trial of Cyclosporine and Tacrolimus Therapy With Steroid Withdrawal in Living-Donor Renal Transplantation
Official title: Randomized Trial of Cyclosporine and Tacrolimus Therapy With Steroid Withdrawal in Living-Donor Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Living Donors
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-10-22
Enrollment: 131
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of steroids after kidney transplantation has been challenged because of variable adverse effects which may increase the patient morbidity and mortality. The aim of this study was to compare the safety and efficacy of immunosuppressive regimens consisting of cyclosporine (CsA) and mycophenolate mofetil (MMF) or tacrolimus (TAC) and MMF after steroid withdrawal 6 months after kidney transplantation in low-risk patients.

Detailed description: 131 patients were randomized to CsA (n = 63) or TAC (n = 68). Of 118 patients who did not have a biopsy-proven rejection episode and who had a serum creatinine level \< 2.0 mg/dL 6 months after transplantation, 55 were of the CsA group and 63 were of the TAC group. We assessed patient and graft survival, acute rejection episodes, and adverse events 5 years after transplantation.

Eligibility criteria: Inclusion Criteria:

* older than 15 years
* first living donor kidney transplantation

Exclusion Criteria:

* congestive heart failure (ejection fraction \< 35%)
* chronic liver disease
* underlying diabetes mellitus
* evidence of systemic infection at screening time
* history of malignant disease
* multiple organ transplantation
* positive serologic evidence of human immunodeficiency virus

Primary outcomes:
measure: Graft survival
timeFrame: 5 years
measure: Patient survival
timeFrame: 5 years
Secondary outcomes:
measure: cumulative incidence of acute rejection
timeFrame: 5 years
measure: estimated glomerular filtration rate
timeFrame: 5 year
measure: new-onset diabetes mellitus
timeFrame: 5 year
measure: Hypertension
timeFrame: 5 year
measure: hyperlipidemia
timeFrame: 5 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Transplantation Center, Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jae-Won Joh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee YJ, Kim B, Lee JE, Kim YG, Kim DJ, Kim SJ, Joh JW, Oh HY, Huh W. Randomized trial of cyclosporine and tacrolimus therapy with steroid withdrawal in living-donor renal transplantation: 5-year follow-up. Transpl Int. 2010 Feb;23(2):147-54. doi: 10.1111/j.1432-2277.2009.00955.x. Epub 2009 Sep 9.
Clinical trial NCT00140933: A Study to Evaluate Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome
Official title: A Randomized, Double-Blind, 7-Day Study of the Efficacy and Safety of Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing the short-term efficacy of rofecoxib versus placebo. Patients receive rofecoxib or placebo or diclofenac and fill out a patient diary on daytime pain severity during daily activities, night pain severity, and acetaminophen/paracetamol intake.


Eligibility criteria: Inclusion Criteria:

* Males or females between the ages of 18 and 59 with acute painful rotator cuff syndrome.

Primary outcomes:
measure: Pain during daily activities assessed by a Numerical Rating Score (NRS)
Secondary outcomes:
measure: Functional impairment evaluated using Neer's functional index.
measure: Global assessment of disease activity by the patient with a NRS.
measure: Intensity of night pain evaluated by NRS.
measure: Rescue treatment take during the study duration.
Other outcomes:
Locations:
city: Paris Cedex 8
country: France
facility: Laboratoires Merck Sharp & Dohme - Chibret
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3.