louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04133727: Suiting up to Empathy
Official title: Suiting up to Teach Pharmacy Students Empathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Empathy
Keywords: randomised
simulation
Lead sponsor: Monash University
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Healthcare professionals with a positive attitude and empathetic towards older adults are at a better position to deliver quality healthcare. In this study, the investigators randomized pharmacy students to either a polypharmacy workshop or an immersive aging simulation suit and polypharmacy workshop to examine if simulation will enhance empathy levels among students

Detailed description: Healthcare professionals with a positive attitude and empathetic towards older adults are at a better position to deliver quality healthcare. In this study, the investigators randomized pharmacy students to either a polypharmacy workshop or an immersive aging simulation suit and polypharmacy workshop to examine if simulation will enhance empathy levels among students. This will be performed in all year 1 pharmacy students

Eligibility criteria: Inclusion Criteria:

* All pharmacy students enrolled in the Pharmacy program

Primary outcomes:
measure: Changes in Jefferson Empathy Scale
timeFrame: Baseline at Week 0 to Post Workshop at Week 12
Secondary outcomes:
measure: Subjective global question seeking opinion on the workshop and activity
timeFrame: Post intervention at Week 12
Other outcomes:
Locations:
city: Subang Jaya
country: Malaysia
facility: Shaun Lee
state: Selangor
Study officials:
affiliation: Monash University
name: Shaun Lee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee SWH, Teh PL. "Suiting Up" to Enhance Empathy Toward Aging: A Randomized Controlled Study. Front Public Health. 2020 Aug 25;8:376. doi: 10.3389/fpubh.2020.00376. eCollection 2020.
Clinical trial NCT02095327: Families Affected by Dementia: A Survey of Caregivers
Official title: Religion and Free Will Perceptions as Coping Mechanisms in Caregivers of Individuals With Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample of caregivers for individuals with dementia

Brief summary: The purpose of our study is to better understand how caregivers of individuals with dementia cope with their family member's illness. If you are eligible for the study and would like to participate, we will schedule a one-time phone interview, which will last approximately 2 hours for which you will be compensated for your time.

Detailed description: Eventually, results of this study will be used to develop treatments that will hopefully help caregivers cope more effectively with managing dementia in a loved one.

Eligibility criteria: Inclusion Criteria:

* Caregiver of individual with dementia
* Relative who is 60 years or older with dementia
* Live-in, unpaid caregiver
* Have a working telephone number

Primary outcomes:
measure: Depression
timeFrame: 3 months
Secondary outcomes:
measure: Anxiety
timeFrame: 3 months
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Amy Weisman de Mamani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03349827: HIPEC and Systemic Chemotherapy Combined With Apatinib in Unresectable Peritoneal Metastases From Gastric Cancer
Official title: A Study of Conversion Therapy Using Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) and Systemic Oxaliplatin/S1 Chemotherapy Combined With Apatinib in Unresectable Peritoneal Metastases From Gastric Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peritoneal Metastases From Gastric Cancer
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The prognosis of patients with unresectable peritoneal metastases from gastric cancer is poor. These patients may obtain survival benefit from radical gastrectomy and cytoreductive surgery (CRS). The response rates of previous conversion therapy are low. Hyperthermic intraperitoneal chemoperfusion (HIPEC) and systemic chemotherapy are effective methods of reducing peritoneal cancer index (PCI) levels. Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with gastric cancer. The purpose of this study is to investigate the efficacy and safety of HIPEC and systemic chemotherapy combined with Apatinib in the conversion therapy of peritoneal metastases from gastric cancer.

Detailed description: To determine the efficacy and safety of HIPEC and systemic chemotherapy combined with Apatinib in the conversion therapy of peritoneal metastases from gastric cancer, patients undergo HIPEC with Docetaxel/ Lobaplatin at the time of fist surgery and twice repeat within one week after the surgery, following 2 cycles of 3-week Oxaliplatin/S1 chemotherapy combined with Apatinib and 1 cycles of 3-week Oxaliplatin/S1 chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Histological proved diagnosis of gastric cancer.
* Unresectable peritoneal metastases and primary tumor proved at surgery.
* No evidence of distant metastases.
* Have not received radiotherapy, chemotherapy or immunotherapy.
* ECOG score: 0\~2.
* Written informed consent is obtained prior to commencement of trial treatment.

Exclusion Criteria:

* Existence of distant metastasis outside the abdomen.
* Any previous radiotherapy, chemotherapy or immunotherapy.
* Active systemic infections.
* Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
* Female patients who are pregnant or breast feeding

Primary outcomes:
measure: radical resection rate
timeFrame: 3 months
Secondary outcomes:
measure: the Peritoneal Cancer Index score
timeFrame: 3 months
measure: overall survival
timeFrame: 3 years
measure: complication rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan University
state: Hubei
Study officials:
References:
Clinical trial NCT04604327: Comparison of Two Different Doses of Bemiparin in COVID-19
Official title: Ensayo clínico Aleatorizado, Abierto, Para Evaluar el Efecto de Dosis profilácticas o terapéuticas de Bemiparina en Pacientes Con COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 164
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: Patients requiring hospitalization due to COVID-19 pneumonia (non-severe) will be randomized to standard prophylactic doses or full therapeutic dose of bemiparin (a LMWH) for 10 days.


Eligibility criteria: Inclusion Criteria:

* Age (equal or more than 18 yo)
* Hospitalization at conventional wards due to COVID-19 related mild or moderate pneumonia (CURB65\<3 points; Sat. O2\>90%)
* 3-4 points according to the WHO ordinal scale.
* Confirmed COVID-19 (PCR or other validated test)
* D-dimer \>500 ng/mL
* Sign of informed consent
* The patient is able, according to investigator's opinion, to deal with all the requirements of the clinical trial.

Exclusion Criteria:

Primary outcomes:
measure: Clinical deterioration
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Móstoles
country: Spain
facility: Hospital Rey Juan Carlos
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitario Bellvitge
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Clínico San carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
Study officials:
affiliation: University of Navarra
name: Ramon Lecumberri, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
citation: Marcos-Jubilar M, Carmona-Torre F, Vidal R, Ruiz-Artacho P, Filella D, Carbonell C, Jimenez-Yuste V, Schwartz J, Llamas P, Alegre F, Sadaba B, Nunez-Cordoba J, Yuste JR, Fernandez-Garcia J, Lecumberri R; BEMICOP Investigators. Therapeutic versus Prophylactic Bemiparin in Hospitalized Patients with Nonsevere COVID-19 Pneumonia (BEMICOP Study): An Open-Label, Multicenter, Randomized, Controlled Trial. Thromb Haemost. 2022 Feb;122(2):295-299. doi: 10.1055/a-1667-7534. Epub 2021 Dec 29.
Clinical trial NCT02107027: Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation
Official title: Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Association de Recherche pour le Traitement des Arythmies Cardiaques
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 58
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 aim of this study is to compare two type of ablation catheters for pulmonary veins isolation (PVI) in subjects with atrial fibrillation.

Currently, two technologies of irrigated ablation catheters are available for PVI.

One of the two, the "conventional" catheter is widely used for atrial fibrillation (AF) treatment but has not been specifically created for pulmonary veins isolation, therefore, point by point encircling lesions are cumbersome and time consuming.

The second is a new ablation catheter with a circular shape provided with 10 irrigated electrodes designed to create encircling lesions, necessary to obtain pulmonary veins isolation, could allow an easier and faster isolation compared to the conventional way.

These two types of catheters have never been compared for atrial fibrillation. If one of the two catheters appears to be more efficient or causes fewer complications, the use of this catheter could be favored to conduct AF ablation.


Eligibility criteria: Inclusion Criteria:

* Subject with atrial fibrillation refractory to anti-arrhythmic drugs, with episodes lasting less than 7 days and eligible for atrial fibrillation ablation.
* Age superior or equal to 18 years old, both genders.
* Patient's oral agreement for study participation after reading information note.
* Patient affiliated or recipient of a social welfare regimen.

Exclusion Criteria:

* Age inferior to 18 years old
* Pregnancy
* Unbalanced psychiatric disorders
* Contraindication to atrial fibrillation ablation by endocardial way.
* Redo-ablation
* No patient's oral agreement for study participation

Primary outcomes:
measure: Number of Pulmonary veins reconnection
timeFrame: End of ablation procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Pierre JAIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04769427: Non-Surgical Rhinoplasty Using PDO Threads
Official title: Non-Surgical Rhinoplasty Using Polydioxanone Threads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Defect
Lead sponsor: DeNova Research
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To determine the effects of absorbable Polydioxanone (PDO) thread non-surgical revision rhinoplasty on first impressions and quality of life (FACE-Q scale) in 10 patients who desire further changes to their nasal tip and/or nasal dorsum


Eligibility criteria: Inclusion Criteria:

1. Males and females of ages 18 and above.
2. Subjects will be required not to have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months.
3. Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visit.

Exclusion Criteria:

1. Males and females below age of 18.
2. Subjects who have had previous surgery, filler injections, or other cosmetic treatments to the nose within the last 12 months.
3. Patients with any prior nasal implants
4. Subjects who are pregnant or nursing.
5. Subjects with a known allergy or sensitivity to any component of the study ingredients.
6. Any history of bleeding disorders (iatrogenic or otherwise). This includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
7. Anyone taking aspirin, ibuprofen, St. John's Wort, or high doses of Vitamin E supplements in the last 3 weeks.
8. Subjects with diseases, injuries, or disabilities of the nose, including those with autoimmune disease affecting the nose
9. Subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required treatment and follow up visit will also be excluded.

Primary outcomes:
measure: Non -surgical rhinoplasty using PDO Max threads
timeFrame: 1 month
Secondary outcomes:
measure: Non -surgical rhinoplasty using PDO Max threads
timeFrame: 1 month
measure: Non -surgical rhinoplasty using PDO Max threads
timeFrame: 1 month
Other outcomes:
Locations:
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
Study officials:
References:
Clinical trial NCT00006127: Phase I Study of Amifostine in Patients With Bone Marrow Failure Related to Fanconi's Anemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Fanconi's Anemia
Keywords: Fanconi's anemia
aplastic anemia
hematologic disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
First posted: 2000-08-04
Enrollment: 21
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Evaluate the toxicity of amifostine in patients with bone marrow failure related to Fanconi's anemia.

II. Determine the efficacy of this treatment regimen in this patient population.

III. Evaluate the effect of this treatment regimen on bone marrow progenitor cell proliferation and peripheral blood mononuclear cell apoptosis in these patients.

Detailed description: PROTOCOL OUTLINE:

This is a dose escalation study.

Patients receive amifostine IV over 3-5 minutes three times a week for three weeks.

Cohorts of 3 patients receive one of three dose levels of amifostine. The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

Patients are followed weekly for 3 weeks.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of Fanconi's anemia by conventional diepoxybutane or mitomycin sensitivity assays, or molecular testing

Bone marrow failure verified on at least 3 occasions in the preceding 3 months by any one of the following: hemoglobin less than 8 g/dL; absolute neutrophil count less than 1,000/mm3; platelet count less than 30,000/mm3; symptomatic bone marrow failure (e.g., exercise limitation from anemia or spontaneous bleeding from thrombocytopenia)

Evidence consistent with myelodysplastic syndrome allowed if less than 5% blasts on bone marrow aspiration; clonality on bone marrow cytogenetic analysis OR morphological changes on bone marrow aspirate

Refusal of or unsuccessful with prior conventional therapies

--Prior/Concurrent Therapy--

Biologic therapy: No prior bone marrow transplantation; no concurrent hematopoietic growth factors

Endocrine therapy: No concurrent androgens

--Patient Characteristics--

Hepatic: Bilirubin no greater than 2 times normal AST no greater than 3 times normal ALT no greater than 6 times normal

Renal: Creatinine no greater than 2 times normal

Other: No prior malignancy; no active bacterial, viral, or fungal infection requiring therapy other than prophylaxis; not pregnant; negative pregnancy test

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: W. Nicholas Haining
role: STUDY_CHAIR
References:
Clinical trial NCT00617227: Serum Vancomycin Levels in Patients Receiving Enteral Vancomycin
Official title: Measurement of Serum Vancomycin in Patients Receiving Enteral ( Oral/Intracolonic) Vancomycin.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clostridium Difficle Colitis
Clostridium Difficle Associated Disease
Keywords: Enteral vancomycin therapy, serum vancomycin levels, renal failure
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2008-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Clostridium difficile associated colitis on enteral vancomycin therapy

Brief summary: The study is based on the hypothesis that decreased creatinine clearance may be associated with detectable vancomycin levels in patients on enteral (oral / vancomycin enemas) vancomyicn for CDAD.

The objective of the study is to see whether enteral vancomycin is absorbed through the inflamed GI mucosa in CDAD, and if it is absorbed, does it achieve measurable serum concentration.

Detailed description: Vancomycin is a large glycopeptide compound with a molecular weight of about 1450 Da. It is not appreciably absorbed orally and is eliminated primarily via the renal route. Enteral vancomycin therapy (oral/intracolonic ) is used inpatients with severe Clostridium difficile associated colitis who are unable to take oral metronidazole or have failed treatment with metronidazole. Oral vancomycin is not detectable in serum of normal persons, but concentrations below therapeutic range may be found in patients with colitis. There are a few case reports of serum concentrations within the therapeutic range after oral/intracolonic administration of vancomycin, in association with renal failure. The use of enteral vancomycin in our geriatric population with variable creatinine clearance prompted us to measure the serum vancomycin levels in these patients.

Eligibility criteria: Inclusion Criteria:

* Patients on enteral vancomycin therapy

Exclusion Criteria:

* Coadministration of intravenous vancomycin therapy,intravenousvancomycin administration in previous10 days.

Primary outcomes:
measure: Patients with detectable serum vancomycin levels during enteral vancomycin therapy
timeFrame: 5-7days
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
affiliation: Maimonides Medical Center
name: Edward K Chapnick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00887627: Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function
Official title: A Phase 1, Open-Label Study to Assess the Effects of Renal Impairment on the Pharmacokinetics of Intravenous Conivaptan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Kidney Diseases
Hyponatremia
Keywords: Pharmacokinetics
Protein Binding
Conivaptan
Vaprisol
Kidney Diseases
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-04-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: A study to compare a conivaptan PK in subjects with mild or moderate kidney function impairment to subjects with normal kidney function after a 48-hour continuous infusion of conivaptan.


Eligibility criteria: Inclusion Criteria:

* Weighs at least 45 kg
* Body mass index between 18 and 40 kg/m2 inclusive
* Must be in good health other than renal function impairment and related stable diseases for the renal impaired subjects
* Must have a screening and pre-dose estimated glomerular filtration rate (GFR) that corresponds with the level of renal impairment based on the abbreviated Modification of Diet in Renal Disease (MDRD) formula
* Female subject of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test, utilizes adequate contraceptive methods while in this study or may be surgically sterile and/or two years post menopausal

Exclusion Criteria:

* Subject is known to be HIV positive or has HIV antibodies
* Has clinically significant history or presence of illness, medical condition, or laboratory abnormality
* Is Hepatitis positive
* Subject with renal impairment has not been on a stable dose of concomitant medications for at least 4 weeks prior to start of study and/or dose changes are likely during the study
* History of substance abuse within 6 months prior to screening
* Has clinically significant history or presence of psychiatric illness, malignancy, or immunodeficiency syndrome
* Has abnormal liver function tests (ALT, AST, and/or bilirubin)
* Has had a blood transfusion or donated/lost more than 450ml of blood within 56 days of study drug administration or has donated plasma within 7 days prior to study drug administration

Primary outcomes:
measure: Measure PK and protein binding of conivaptan
timeFrame: 5 days
Secondary outcomes:
measure: Measure safety and tolerability of conivaptan
timeFrame: 5 days
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
Study officials:
affiliation: Cumberland Pharmaceuticals, Inc.
name: Art Wheeler, MD
role: STUDY_DIRECTOR
References: