louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05561777: Penicillin Allergy Risk-Stratification and Delabeling of Low-Risk Patients
Official title: Implementation of Penicillin Allergy Risk Stratification and Delabeling of Low-Risk Patients: Provider-Targeted Clinical Decision Support Versus Pharmacist-Led Approach
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Antibiotic Allergy
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Children are often reported to have antibiotics allergies, with approximately 10% of the US population labeled as allergic to an antibiotic, however, recent studies have demonstrated that the majority of symptoms reported as an allergy by parents are often non-IgE-mediated adverse reactions or symptoms of a viral illness (e.g. rash, vomiting, diarrhea). Additionally, over 90% of patients with reported penicillin allergy have negative skin testing results. Several studies in children have found that an allergy questionnaire can accurately identify those who are at low risk for severe antibiotic allergy and the allergy label can be safely removed. Appropriately delabeling antibiotic allergies has been shown to improve patient care through changing prescribing behavior and lowering health care costs.

In this study, the investigators will perform a randomized trial comparing a provider-targeted clinical decision support tool to a pharmacist-led approach. The physician-targeted CDS tool will inform providers of their patient's allergy risk stratification result, protocol, electronic health record order and documentation support. The pharmacist-led approach consists of electronic health record dashboard that includes identical information to the provider arm. The primary outcome will be the frequency of penicillin allergy encounters with an allergy label removed at the time of discharge. Secondary outcomes will include the percentage of encounter with a penicillin allergy label in the electronic medical record 3 months after discharge, hospital length of stay and antibiotic utilization.


Eligibility criteria: Inclusion Criteria:

Pediatric Hospital Medicine service Existing penicillin allergy label in the EHR Screened as low-risk for true PCN allergy (based on usual-care nursing intake questions at time of admission)

Exclusion Criteria:

None, provider may opt out of CDS tool at any time

Primary outcomes:
measure: Allergy Delabeling Performed
timeFrame: Within 1 day of discharge for each encounter
Secondary outcomes:
measure: Allergy Label Adjustments in EHR
timeFrame: 3 months after discharge for each encounter
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carell Jr Children's Hospital at Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: James Antoon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02623777: Effect of Arabinoxylan Oligosaccharides Consumption on Insulin Resistance in Patients With Metabolic Syndrome
Official title: Evaluation of the Effect of Arabinoxylan Oligosaccharides Consumption on Insulin Resistance in Patients With Metabolic Syndrome and the Contribution of Short-chain Fatty Acids Production
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: During this project the investigators will evaluate whether the effects of arabinoxylan oligosaccharides (AXOS) consumption on insulin resistance in participants with metabolic syndrome can be explained by the production of short-chain fatty acids (SCFA). Secondly, the investigators will evaluate whether changes in gut hormone production might explain the effect on insulin resistance.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years
* Regular diet (3 meals/day on at least 5 days/week)
* Central obese (defined as waist circumference ≥ 94cm for Europid men and ≥ 80cm for Europid women, with ethnicity specific values for other groups)
* Insulin resistant: HOMA-IR \> 1.7 or fasting glucose \> 100mg/dL
* And one of the following three factors:

  * Elevated TG level: ≥ 150 mg/dL (1.7 mmol/L)
  * Decreased HDL cholesterol level: \< 40 mg/dL (1.03 mmol/L\*) in males and \< 50 mg/dL (1.29 mmol/L\*) in females
  * Elevated blood pressure (BP): systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg

Exclusion Criteria:

* Low calorie diet or other special diet during the study or during the last month prior to the study
* Serious chronic disease of the gastrointestinal tract, such as inflammatory bowel disease (Crohn's disease or ulcerative colitis), irritable bowel syndrome, chronic constipation (less than 3 bowel movements a week), chronic frequent diarrhoea (more than 3 stools a day), clinically relevant lactose intolerance, ...
* Use of antibiotics during the last month before starting the study
* Abdominal surgery in the past (except from appendectomy)
* Use of medication that affects the gastro-intestinal tract during the last 2 weeks prior to the study including spasmolytics, anti-diarrhoea medication, anti-constipation medication, and/or pre- or probiotic supplements (e.g. lacteol, Enterol)
* Pregnancy, pregnancy desire or lactation
* Diabetes (type 1 or 2), i.e. HbA1c \> 6.5 %
* Abnormal haemoglobin (Hb) levels in blood, men must have an Hb level between 14.0 and 18.0 g / dL and women between 12.0 and 16.0 g / dL.

Primary outcomes:
measure: Change in insulin resistance after both interventions using the homeostatic model assessment for insulin resistance
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02716077: Early FDG PET in Melanoma
Official title: Early FDG PET/CT Imaging as a Measure of Response in Patients With Melanoma on Pembrolizumab.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Clinical Stage III Nodal or Intransit Disease or Resectable Stage IV Melanoma
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Adult patients with histologically proven melanoma who will be treated with pembrolizumab will undergo FDG PET/CT scan as an early evaluation of response to therapy. Changes in FDG uptake will be correlated with lab and pathology results.


Eligibility criteria: Inclusion Criteria:

* Adult patients, at least 18 years of age
* History of histologically confirmed melanoma as assessed per medical record review.
* Eligible for the trial UPCC #01615, "A Phase Ib Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects with Resectable Advanced Melanoma."
* Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

* Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine or serum pregnancy test at the time of the screening visit.
* Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
* Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
* Ineligible for the trial UPCC #01615, "A Phase Ib Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects with Resectable Advanced Melanoma."
* Only individuals (aged 18 or over) who can understand and give informed consent will be eligible to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care. This should negate any undue influence or coercion. Children, fetuses, neonates, or prisoners are not included in this research study.

Primary outcomes:
measure: disease-free survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Michael Farwell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05790577: Comparison of 30% Metformin and 2% Nicotinamide Lotion With Kligman Formula in the Treatment of Melasma
Official title: Comparison of 30% Metformin and 2% Nicotinamide Lotion With Kligman Formula in the Treatment of Melasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melasma
Lead sponsor: Pak Emirates Military Hospital
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma

Detailed description: A comparative study to evaluate Efficacy and tolerability of new lotion in the treatment of Melasma.

Eligibility criteria: Inclusion Criteria:

* Age between 18-50
* No systemic therapy
* All Co-morbids

Exclusion Criteria:

* Pregnancy
* Age \>50
* Taking oral treatment for melasma

Primary outcomes:
measure: Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: PakEmiratesMH
state: Punjab
Study officials:
affiliation: Pak Emirates Military Hospital
name: Ishtiaq Ahmed, MBBS
role: STUDY_DIRECTOR
References:
Clinical trial NCT05577377: OM and Trauma Study
Official title: An Unblinded, Uncontrolled, 1-month Interventional Single Group Pilot Study, to Assess the Possibility of Orgasmic Meditation Practice Being Used as a Possible Intervention for PTSD.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: PTSD
Lead sponsor: Institute of OM Foundation
Sponsor class: INDUSTRY
First posted: 2022-10-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre and Post Intervention Study with Orgasmic Meditation - a meditation practice
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to use an unblinded, uncontrolled, 1-month interventional single group pilot study, to assess the possibility of Orgasmic Meditation practice being used as a possible intervention for PTSD. The secondary purpose of this study is to examine if OM is associated with a decrease in the symptoms and self-assessed experiences associated with trauma.

The OM Trauma Protocol (OMTP) is designed to systematize the application of Orgasmic Meditation (OM) for individuals seeking relief from a wide variety of problems and/or help them in their pursuit of eudaimonia. The study protocol will evaluate whether OMing (the act of practicing OM) shows potential for being an effective intervention for people suffering from Post-Traumatic Stress Disorder (PTSD).


Eligibility criteria: Inclusion Criteria:

* Adults ≥18 years old
* One or more participants of the pair having a diagnosis of PTSD for \> 6 months
* Relationship for \> 6 months
* Self or partner of female sex
* Massachusetts residents
* Access and ability to use internet and a video platform called Zoom
* No history of doing the practice of OM

Exclusion Criteria:

* Ongoing or active use of illicit drugs at the time of the study
* Self-identify as pregnant
* Inability to speak English
* Recent hospitalization \< 12 months
* Suicidal ideation \< 12 months
* Self-harm \< 12 months

Primary outcomes:
measure: Correlation between OM and PTSD symptoms
timeFrame: 4 weeks
measure: Number of participants who withdraw from the study
timeFrame: 4 weeks
measure: Number of participants who score a 39 or higher using the OM perceived value survey
timeFrame: 4 weeks
Secondary outcomes:
measure: Correlation between Eudaimonia and OM
timeFrame: 4 weeks
measure: Correlation between depression and OM
timeFrame: 4 weeks
measure: Correlation between anxiety and OM
timeFrame: 4 weeks
measure: Correlation between psychosocial functioning and OM
timeFrame: 4 weeks
Other outcomes:
measure: Correlation between OM and tumescence
timeFrame: 4 weeks
Locations:
city: Santa Rosa
country: United States
facility: Institute of OM Foundation
state: California
Study officials:
affiliation: Institute of OM Foundation
name: Dan Kriegman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04126577: Clinical Relevance of the Reverse Lipopolysaccharide Transport Pathway in Patients With Acute Peritonitis
Official title: Clinical Relevance of the Reverse Lipopolysaccharide Transport Pathway in Patients With Acute Peritonitis An Observational Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritonitis
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with secondary peritonitis, sepsis and endotoxemia

Brief summary: When there is infection in the intra-abdominal area, bacteria secrete toxins that are absorbed by the peritoneum. These toxins then bind to lipoproteins (which carry cholesterol in the blood) and are eliminated by the liver. Phospholipid transfer protein (PLTP) is a protein that facilitates the binding of bacterial toxins to lipoproteins and thus their elimination.

The objective of this study is to study the relationship between PLTP and the elimination of bacterial toxins in humans. A better understanding of the elimination of these toxins will lead to a better understanding of the disease. The ultimate objective is to improve the management of intra-abdominal infections.


Eligibility criteria: Inclusion Criteria:

* person who has given oral consent (patient or family member)
* pre-operative SEPSIS criteria (qSOFA \>=2) or vasopressor or mechanical ventilation treatment
* admitted to the operating room for suspected generalized secondary peritonitis

Exclusion Criteria:

* person not affiliated to national health insurance
* person under legal protection (curatorship, guardianship)
* person under court order
* pregnant, parturient or breastfeeding woman
* minor
* immunosuppression (HIV infection, corticosteroid treatment \> 0.15 mg/kg/day prednisolone equivalent \> 2 weeks, immunosuppressive treatment, primary cellular immune deficiency)
* decision to limit or stop therapy

Primary outcomes:
measure: Perioperative plasma concentration in 3HM
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT00892853: Association of Bone Quality and Quantity With Vascular Calcification
Official title: Association of Bone Quality and Quantity With Vascular Calcification.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vascular Calcification
Atherosclerosis
Bone Density
Keywords: calcification
osteoporosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2009-05-05
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if there is a link between calcium build up in the veins or arteries (including the veins/arteries of the heart) and deterioration of the bone. This will help understand if there is a connection between heart disease and bone disease.


Eligibility criteria: Inclusion Criteria:

* Male or Female
* 30 years of age or older
* Must already be scheduled to have a CT examination of the arteries of the heart

Exclusion Criteria:

* Diagnosed with bone cancer
* Previous diagnosis of cancer that's spread to the bone
* History of cancer that involves bone marrow
* Any bone disease other than osteoporosis
* Any disease which leads to serious osteoporosis or vascular calcification such as:

  * kidney disease
  * thyroid and adrenal disease
  * anorexia nervosa
  * secondary osteoporosis

Primary outcomes:
measure: To determine if there is a connection between heart disease and bone disease through correlation of bone density with the calcium deposited in the coronary arteries.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Yebin Jiang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00895453: Monthly Itraconazole Versus Classic Homeopathy for Treatment of Recurrent Vulvovaginal Candidiasis (RVVC)
Official title: Monthly Itraconazole Versus Classic Homeopathy for the Treatment of Recurrent Vulvovaginal Candidiasis: a Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvovaginal Candidiasis
Keywords: recurrent vulvovaginal candidiasis
itraconazole
classic homeopathy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-05-08
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective study to evaluate the efficacy of classic homeopathic therapy compared to maintenance itraconazole therapy with and without additional exogenous lactobacillus for treatment of recurrent Candida vaginitis.

Detailed description: Objective:

Antimycotics effectively treat sporadic and recurrent vulvovaginal candidiasis (RVVC). Classic homeopathy (CH) is also used to treat this condition. We compared the efficacy of CH and itraconazole in reducing the frequency of RVVC episodes.

Design:

Single-centre, prospective, randomized.

Sample:

One-hundred-and-fifty patients with a history of RVVC and an acute episode of VVC.

Methods:

Women were randomised into 3 groups: itraconazole with lactobacilli (group 1), itraconazole without lactobacilli (group 2) and CH (group 3). Itraconazole treatment of acute infection was followed by a 6-months maintenance regimen with monthly single-day itraconazole (200 mg bid). Thereafter, patients were followed without treatment for 6 months. Women in group 1 were given additional vaginal lactobacilli for six days per month. CH treatment was performed for 12 months.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years, premenopausal
* Negative pregnancy test
* Signed informed consent
* At least 4 Episodes of Candidiasis within the last year
* Candida detectable by culture
* Negative Hepatitis- and HIV-Serology
* No Allergy to Itraconazole

Exclusion Criteria:

* Under 18 years

Primary outcomes:
measure: Candida Culture Free After Maintenance Therapy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Medical School
Study officials:
affiliation: Vienna Medical School
name: Armin Witt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00257153: Thrombus Aspiration Before Standard Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction
primary angioplasty
myocardial reperfusion
thrombus aspiration
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
First posted: 2005-11-22
Enrollment: 160
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients with acute ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) may cause thrombus dislodgment and impaired microcirculatory reperfusion. This study was designed to test the hypothesis that thrombus aspiration before standard PCI may improve acute myocardial reperfusion, measured by ST-segment resolution (STR) and myocardial blush grade (MBG), compared with standard PCI.

Detailed description: Consecutive STEMI patients, admitted within 12 hours of symptom onset and scheduled for primary PCI are randomly assigned to two treatment strategies: standard PCI including stenting and abciximab (group1) or thrombus aspiration with Pronto™ extraction catheter (Vasc.solutions, Minneapolis) before standard PCI (group2). Patients with cardiogenic shock, previous infarction or thrombolytic therapy are excluded.

Eligibility criteria: Inclusion Criteria:

* ST-segment elevation myocardial infarction patients undergoing primary angioplasty within 12 hours from symptom onset.

Exclusion Criteria:

* Cardiogenic shock, previous infarction, previous coronary bypass surgery,bundle branch block or pacemaker induced rythm, controindications to IIb/IIIa inhibitors.

Primary outcomes:
measure: ST-segment resolution immediately after primary angioplasty
measure: Myocardial Blush grade after angioplasty.
Secondary outcomes:
measure: Coronary TIMI flow grade,
measure: distal embolization,
measure: no reflow
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Cardiology department, Niguarda hospital
Study officials:
affiliation: Interventional cardiology laboratory, Cardiology Dpt, Niguarda Hospital
name: Pedro L Silva-Orrego, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiology Dpt. of medicine and surgery, University school of medicine, Milan, Italy
name: Riccardo Bigi, MD
role: STUDY_CHAIR
affiliation: Cardiology Dpt. Niguarda hospital
name: Paola Colombo
role: STUDY_DIRECTOR
affiliation: cardiology Dpt. Niguarda hospital.
name: Silvio Klugmann, MD
role: STUDY_CHAIR
References:
citation: Silva-Orrego P, Colombo P, Bigi R, Gregori D, Delgado A, Salvade P, Oreglia J, Orrico P, de Biase A, Piccalo G, Bossi I, Klugmann S. Thrombus aspiration before primary angioplasty improves myocardial reperfusion in acute myocardial infarction: the DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) study. J Am Coll Cardiol. 2006 Oct 17;48(8):1552-9. doi: 10.1016/j.jacc.2006.03.068. Epub 2006 Sep 26.