louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03886155: Cardiac Amyloidosis Screening at Trigger Finger Release
Official title: Cardiac Amyloidosis Screening at Trigger Finger Release
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyloidosis
Trigger Finger
Transthyretin Amyloidosis
Primary Amyloidosis of Light Chain Type
Keywords: Surgery
Surgical release
Biopsy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 107
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing trigger finger release surgery

Brief summary: The investigators will prospectively evaluate for the presence of amyloid deposits in soft tissue samples obtained from patients undergoing trigger finger release surgery. Patients who have tissue that stains positive for amyloid will be referred to an amyloidosis specialist.

Detailed description: A prospective study in 2001 showed that 23% (n = 47) of biopsies for idiopathic trigger finger were positive for Congo red staining but negative for ATTR and AL amyloid via immunohistochemistry. However, mass spectrometry is now the preferred method to type amyloid tissue. Trigger finger pathology involves the same flexor tenosynovium that passes through the carpal tunnel and has been biopsied to diagnose amyloidosis. Our recent study found that 10% of older patients undergoing carpal tunnel release surgery were positive for amyloidosis, with 20% of that group presenting with cardiac involvement. 60% of the amyloid-positive group had a history of trigger finger. Surgical intervention for trigger finger could provide an opportunity to screen for amyloidosis through tenosynovial biopsy.

This study will look at the prevalence of amyloidosis in patients undergoing surgical intervention for idiopathic trigger finger. The study hypothesis is at least 10% of such patients will be positive for amyloidosis.

Eligibility criteria: Inclusion Criteria:

* Age ≥50 years at the time of surgical biopsy.
* Undergoing surgical intervention for idiopathic trigger finger.
* Able to consent.

Exclusion Criteria:

* Known history of amyloidosis.

Primary outcomes:
measure: Incidence of amyloidosis in older patients undergoing trigger finger release
timeFrame: Baseline to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Mazen A Hanna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cordiner-Lawrie S, Diaz J, Burge P, Athanasou NA. Localized amyloid deposition in trigger finger. J Hand Surg Br. 2001 Aug;26(4):380-3. doi: 10.1054/jhsb.2001.0571.
citation: Sperry BW, Reyes BA, Ikram A, Donnelly JP, Phelan D, Jaber WA, Shapiro D, Evans PJ, Maschke S, Kilpatrick SE, Tan CD, Rodriguez ER, Monteiro C, Tang WHW, Kelly JW, Seitz WH Jr, Hanna M. Tenosynovial and Cardiac Amyloidosis in Patients Undergoing Carpal Tunnel Release. J Am Coll Cardiol. 2018 Oct 23;72(17):2040-2050. doi: 10.1016/j.jacc.2018.07.092.
Clinical trial NCT00793455: Outreach for Patients With Uncompleted Colorectal Cancer Screening Orders
Official title: Using Precision Performance Measurement To Conduct Focused Quality Improvement. Sub-Study 1.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Prevention & Control
Keywords: education
preventive service
screening
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2008-11-19
Enrollment: 628
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate whether patient outreach is effective at increasing compliance with preventive screenings ordered by their physician. We hypothesize that educational outreach may increase completion rates.

Detailed description: We designed an intervention to focus on patients who have received and accepted a referral for colonoscopy, yet have exhibited some barriers to screening as demonstrated by a lack of screening completion. We conducted a randomized controlled trial to assess the effects of a multicomponent intervention (patient reminder, print and multimedia materials) on colorectal screening completion among this target population.

Eligibility criteria: Inclusion Criteria:

* Patient's physician has ordered a preventive screening test
* Patient has not completed this test in 3 months
* Patient of Northwestern Medical Faculty Foundation General Internal Medicine Clinic.

Exclusion Criteria:

* Patient has been given a more recent order for the same screening test.
* Patient has significant life stress as noted in the Electronic Health Record (EHR)

Primary outcomes:
measure: Colorectal Cancer Screening Completion.
timeFrame: 3 months post randomization
Secondary outcomes:
measure: Colorectal Cancer Screening Completion
timeFrame: 6 months post randomization
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation General Internal Medicine Clinic
state: Illinois
Study officials:
affiliation: Northwestern University
name: Kenzie A Cameron, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cameron KA, Persell SD, Brown T, Thompson J, Baker DW. Patient outreach to promote colorectal cancer screening among patients with an expired order for colonoscopy: a randomized controlled trial. Arch Intern Med. 2011 Apr 11;171(7):642-6. doi: 10.1001/archinternmed.2010.468. Epub 2010 Dec 13.
Clinical trial NCT01423955: Erythropoietin (EPO) to Protect Renal Function After Cardiac Surgery
Official title: EPO to Protect Renal Function After Cardiac Surgery. A Phase II Double Blind Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Failure
Renal Failure
Keywords: Erythropoietin
Erythropoetin
Cardiac surgery
Ischemia
Reperfusion
Renal function
Cystatin C
Creatinine
Safety
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2011-08-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the potential of erythropoietin in reducing risk and degree of acute kidney injury after cardiac surgery.

Detailed description: Acute kidney injury is a common complication after cardiac surgery and is associated with decreased long-term survival.

Several experimental and animal studies have showed cytoprotective, preconditioning and anti-apoptotic effects of high dose erythropoietin. Clinical studies in human have also suggested that high dose erythropoietin has preconditioning effects against injury after ischemia and reperfusion on different organs in human, such as brain, heart, liver, and kidneys.

Administration of Epo in high doses in conjunction with cardiac surgery has shown to be safe with no direct side-effects.

The investigators therefore hypothesize that a preconditioning effect of erythropoietin before cardiac surgery can reduce the level of renal dysfunction after surgery in a group with preoperative renal impairment.

Eligibility criteria: Inclusion Criteria:

* The patient is scheduled for non-emergent CABG surgery.
* CyC eGFR or MDRD eGFR \< 60 ml/min.
* The patient has given his/her written consent to participate

Exclusion Criteria:

* The patient has an uncontrolled hypertension.
* Hypersensitivity to the active drug.
* The patient is pregnant or is a fertile woman (\<50 years).
* The patient has been treated with Erythropoietin within 4 weeks prior to the surgery.
* Preoperative CyC eGFR or MDRD eGFR is \< 15, or the patient is treated with dialysis.
* The patient has a known malignancy.
* The patient is planned for Off-pump CABG surgery.
* The patient is included in other ongoing clinical trial. Yes / No
* Clinically judgment by the investigator that the patient should not participate in the study.

Primary outcomes:
measure: Change in plasma cystatin C measured on day 3 postoperatively.
timeFrame: 3 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Dept Thoracic Surgery, Anestesia and Intensive Care, SUS-Lund
Study officials:
affiliation: Region Skane
name: Henrik Bjursten, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00630955: Family History Study of Alcohol Consumption Using Memantine
Official title: NMDA Antagonist Efficacy in Reducing Human Alcohol Consumption: Impact of Family History
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Drinking
Keywords: Alcohol Drinking
Memantine
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2008-03-07
Enrollment: 111
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the effects of the study medication, memantine (placebo, 20 mg or 40 mg/day) on alcohol drinking behavior in a laboratory setting in which participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. We hypothesize that memantine will reduce craving and number of drinks consumed prior to and after exposure to the initial drink of alcohol and during the three hour drinking period. We will also evaluate the influence of family history of alcoholism on the efficacy of memantine in reducing alcohol drinking behavior.


Eligibility criteria: Inclusion Criteria:

* Ages 21-50
* Able to read English at 6th grade level or higher and to complete study evaluations
* Regular alcohol drinker

Exclusion Criteria:

* Individuals who are seeking alcohol treatment
* Medical conditions that would contraindicate the use of memantine
* Regular use of other substances

Primary outcomes:
measure: Number of Drinks Consumed on Day 7
timeFrame: Day 7
measure: Baseline-adjusted Craving (YCS)
timeFrame: Day 7
Secondary outcomes:
measure: Stimulation Responses to Alcohol
timeFrame: Day 7
measure: Sedation Responses to Alcohol
timeFrame: Day 7
Other outcomes:
Locations:
city: New Haven
country: United States
facility: CMHC
state: Connecticut
Study officials:
affiliation: Yale University
name: Suchitra Krishnan-Sarin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01535755: A Protocol to Wean From Noninvasive Mechanical Ventilation
Official title: A Protocol to Wean From Noninvasive Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ventilator Weaning
Keywords: noninvasive mechanical ventilation
ventilator weaning
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2012-02-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The investigators use a protocol to wean from noninvasive mechanical ventilation.

Detailed description: Design: Prospective, randomized, controlled trial, with 2 groups: study (protocol weaning group) and control (clinicians' order weaning group). Setting: Respiratory Intensive Care Unit (RICU). Subjects: Patients \>18 yr, noninvasive mechanical ventilation \>24 hours. Interventions and measurements: Study group (weaning as the protocol) and control group (weaning as the clinicians' order); recording of clinical variables at admission and during RICU stay, and end-point variables (noninvasive mechanical ventilation day, RICU and hospital stay, RICU mortality. Expected results: the protocol group's noninvasive mechanical ventilation days is less than clinicians' order group.

Eligibility criteria: Inclusion Criteria:

1. noninvasive mechanical ventilation \> 24 hours.
2. age \>18 years

Exclusion Criteria:

1. severe cerebraI，heart，hepatic and renal faiIure.
2. facial or cranial trauma or surgery.
3. facial abnormalities.
4. recent gastric or esophageal surgery.
5. active upper gastrointestinal bleeding.
6. large amount of sputum with weak cough ability
7. lack of co-operation.

Primary outcomes:
measure: The duration of noninvasive mechanical ventilation
timeFrame: from admission to ICU to discharge from it (average of 4 weeks)
Secondary outcomes:
measure: The successful weaning rate
timeFrame: from admission to ICU to discharge from it (average of 4 weeks)
measure: The length of ICU days
timeFrame: from admission to ICU to discharge from it (average of 4 weeks)
measure: The intubation rate during the study
timeFrame: from admission to ICU to discharge from it (average of 4 weeks)
measure: The mortality during the study
timeFrame: from admission to ICU to discharge from it (average of 4 weeks)
Other outcomes:
Locations:
city: ChongQing
country: China
facility: The first affiated hospital, chongqing medical university
state: Chongqing
Study officials:
affiliation: The first affiliated hospital, Chongqing medical hospital
name: Jun Duan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01898455: Intranasal Cooling for Cluster Headache and Migraine
Official title: IntraNasal Evaporative Cooling for the Symptomatic Relief of Migraine and Cluster Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Cluster Headache
Keywords: Migraine
Cluster headache
headache
Lead sponsor: Cumbria Partnership NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: BeneChill, Inc
First posted: 2013-07-12
Enrollment: 15
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: This study will be looking at the clinical efficacy of using a intranasal evaporative cooling device in providing relief of the symptoms of migraine and cluster headache. It will involve using a nasal catheter to spray a liquid coolant into the nasal cavity where it evaporates and removes heat from the tissue, thereby cooling the tissue and the blood vessels which supply blood to the brain. This cooling effect will cause the blood vessels to constrict and it is thought that this may provide symptomatic relief in both these forms of headache. 10 migraine patients and 5 cluster headache patients will be enrolled in the study and will receive 10 treatments each, for a maximum of 20 minutes at a time. They will be monitored during the treatment and for two hours afterwards to assess headache severity and side effects. There will be a further follow up 2 months after the last treatment to assess for longer term side effects from the treatment.


Eligibility criteria: Inclusion Criteria:

* \>18 Years old.
* Meets criteria for NICE guidelines diagnosis of cluster headache or chronic migraine
* Has not responded satisfactorily to migraine prophylaxis or standard analgesia
* Capable of giving informed consent

Exclusion Criteria:

* \< 18 years of age
* Subject has history of other severe co-morbid illness which would prevent full participation in the study
* Inability to insert the nasal cannulae
* Known temperature sensitive disorder such as reynauds, cryoglobulinaemia
* Known oxygen dependency to maintain SaO2 \>95%

Primary outcomes:
measure: • Reduction of pain score and overall symptoms from baseline in Migraine/cluster headache sufferers
timeFrame: 20 minutes
Secondary outcomes:
measure: Tolerance to Rhinochill cooling during maximum 20 minutes treatment
timeFrame: 20 minutes
measure: Adverse events noted throughout treatment phase and during follow up
timeFrame: 1 year
Other outcomes:
Locations:
city: Penrith
country: United Kingdom
facility: Neurosciences department, Penrith Hospital, Cumbria Partnership NHS Foundation Trust
state: Cumbria
Study officials:
affiliation: Cumbria Partnership NHS Foundation Trust
name: Jitka Vanderpol, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vanderpol J, Bishop B, Matharu M, Glencorse M. Therapeutic effect of intranasal evaporative cooling in patients with migraine: a pilot study. J Headache Pain. 2015 Jan 26;16:5. doi: 10.1186/1129-2377-16-5.
Clinical trial NCT03537755: Black Adolescent & Entertainment Study
Official title: The Effect of Food Marketing and Attentional Biases on Eating Behaviors in African American Adolescent Girls
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity, Childhood
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Uniformed Services University of the Health Sciences
First posted: 2018-05-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Black/African American girls 12-17 years old

Brief summary: The study is being conducted to obtain adolescent girls' thoughts and opinions on relationship and communication styles are shown on television.


Eligibility criteria: Inclusion Criteria:

1. Female,
2. Self-identify as African American or Black,
3. 12 to 17 years of age at the start of the study,
4. Presence of obesity by virtue of a body mass index (BMI) ≥ 95th percentile for age and sex or non-overweight by virtue of a BMI of at least the5th percentile, but below the 85th percentile, for age and sex,118 and
5. English speaking.

Exclusion Criteria:

1. Reports of the presence of a major chronic medical illness: renal, hepatic, gastrointestinal, endocrinologic (e.g., Cushing syndrome, hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication),
2. Individuals who self-report major depressive disorder, psychoses, current substance or alcohol use disorder, or any other psychiatric disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study.
3. Current, regular use of prescription medications that affect appetite, mood, or body weight: currently prescribed serotonin re-uptake inhibitors (SSRIs), neuroleptics, tricyclics, stimulants, or any other medication known to affect appetite, mood, or body weight. Oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before the study visit,
4. Failure to provide a rating of 6 or more on at least 50% of food items on the Food Preferences Questionnaire (Appendix F); exceptions may be given for restrictions due to religious practices or food allergies, if food items can be replaced with items of equivalent macronutrient content.

Primary outcomes:
measure: Total energy consumption
timeFrame: Day 1
measure: Macronutrient intake
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of the Health Sciences
state: Maryland
Study officials:
References:
Clinical trial NCT00164255: Efficacy of Combination Therapy for Prevention of Effects of Malaria During Pregnancy
Official title: Efficacy of Intermittent Sulfadoxine-Pyrimethamine and Sulfadoxine-Pyrimethamine + Artesunate Treatment in the Prevention of Malaria in Pregnancy in an Area With Chloroquine-Resistant Plasmodium Falciparum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Keywords: malaria
birthweight
placental malaria
intermittent protective treatment
sulfadoxine/ pyrimethamine
artesuate
combination therapy
Pregnancy
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Ifakara Health Research and Development Centre
First posted: 2005-09-14
Enrollment: 1614
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is an investigation to compare the efficacy of two different intermittent sulfadoxine/pyrimethamine (SP) treatment regimens and intermittent sulfadoxine/pyrimethamine (SP) + artesunate (SP/AS) treatment of HIV negative and positive mothers in clearing placental parasitemia at delivery. If intermittent protective SP/AS treatment is equally efficacious and safe as intermittent protective SP, such a regimen could be adapted for programmatic use as a potentially more durable alternative to SP monotherapy in areas of increasing SP resistance.


Eligibility criteria: Inclusion Criteria:

* Women 15 years of age or older
* First or second pregnancy between 16 and 36 weeks gestation

Exclusion Criteria:

* Pregnancy prior to 16 weeks or after 36 weeks gestation
* Third or later pregnancy;
* Report previous allergic reactions to SP, AS, or unknown antimalarials;
* If the distance to their home is too great or too inaccessible for follow-up;
* Child's father refuses the woman's participation

Primary outcomes:
measure: placental parasitemia
measure: reported or noted adverse reactions
Secondary outcomes:
measure: parasitemia at delivery (maternal peripheral, placental and cord)
measure: maternal illness
measure: birth weight
measure: gestational age
measure: fetal and infant health
measure: impact of maternal HIV infection on efficacy of malaria prevention during pregnancy
Other outcomes:
Locations:
city: Ifakara
country: Tanzania
facility: Kibaoni Health Centre
state: Kilombero District
city: Ifakara
country: Tanzania
facility: St Francis Designated District Hospital
state: Kilombero District
Study officials:
affiliation: Centers for Disease Control and Prevention
name: John MacArthur, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Ifakara Health Research and Development Centre
name: Salim Abdulla, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: