louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04431297: Virtual Mindfulness Rounds in the Time of COVID-19 Pandemic
Official title: The Impact of Virtual Mindfulness Education Sessions on Staff Perceived Stress During COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stress
Keywords: Stress mindfulness
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Mindfulness education will be provided via a virtual platform to see if staff stress can be decreased during this time of pandemic.

Detailed description: Healthcare workers have been front and center in battling the COVID crisis. This is a situation the researchers could never have envisioned before it happened. Of course, this has triggered an inordinate amount of stress. Research shows that chronic stress leaves one imbalanced and one's health and happiness to suffer. Research has also demonstrated that how one thinks about stress determines how the body responds to it. Simple mindfulness practices provide healthier ways to deal with stress. In this study, the researchers will introduce modified mindfulness practices that can be practiced in the healthcare setting or at home. All of the practices are based on mindfulness principles. Mindfulness refers to a state of being present in the moment, on purpose, and without judgment. "Mindfulness Based Stress Reduction" is an 8 week, 2 hours/week curriculum that has shown results for over 40 years. All the practices in this study are adapted from that protocol.

The intervention includes several mindfulness practices including an awareness of breath focus instruction, breath-and-body coordination and awareness instruction, and instruction in identifying times to practice these exercises. The intervention will be delivered virtually 2-day/week, twice/day, for four weeks.

Effectiveness will be measured by the voluntary, anonymous submission of a Perceived Stress Scale, a validated survey tool to determine an individual's perceived stress level.

Participants will be healthcare workers and hospital staff in the Mount Sinai Hospital system.

Eligibility criteria: Inclusion Criteria:

* Mount Sinai Hospital employee

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in Perceived Stress Scale
timeFrame: baseline and Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jeffrey Zahn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01501097: The Impact of Continuous Renal Replacement Therapy on the Outcomes of Burn Patients With Early Phase of Sepsis
Official title: A Randomized Controlled Trial on the Impact of Early Application of CRRT on the Outcomes of Burn Patients With Early Phase of Sepsis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burns
Sepsis
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 determine if early application of CRRT will result in an improvement of clinical outcomes of burn patients during the early phase of sepsis

Detailed description: The impact of Continuous Renal Replacement Therapy (CRRT) on the outcomes of patients with sepsis is controversial, and there is no consensus for the timing and dose of CRRT may improve the outcomes. The purpose of this prospective randomized study is to assess the effect of different CRRT intensity (25ml/kg/h or 50ml/kg/h) on the outcomes of burn patients with early phase of sepsis

Eligibility criteria: Inclusion Criteria:

* patients with documented sepsis
* clinically identified focus of infection associated with at least 2 SIRS -criteria and one or more sepsis-induced organ failures within the 24 hours -prior to inclusion
* age 18 to 70 years
* severe burned patients with 50% \< TBSA \< 85%

Exclusion Criteria:

* cirrhosis child class C
* too high APACHE II \& SOFA score at admission
* age over 70 years
* were presence of a malignant tumor, chronic renal insufficiency (serum creatinine \> 133 µmol/L), moribund state, receiving immunosuppressive therapy or receiving any kind of renal replacement therapy before randomization

Primary outcomes:
measure: Changes in serum cytokine concentrations and clearance
timeFrame: 96 hours
Secondary outcomes:
measure: 28 and 90 days survival
timeFrame: 90 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
References:
Clinical trial NCT03584997: Ridge Preservation In Mandibular Molars Using Mixture Of ABB And Autogenous Particulate VS Sticky Bone
Official title: Alveolar Ridge Preservation In Mandibular Molars Using Mixture Of Anorganic Bovine Bone(ABB) And Autogenous Particulate VS Mixture Of Injectable Platelets Rich Fibrin, ABB And Autogenous Particulates (Sticky Bone).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Bone Loss
Bone Graft Failure
Alveolar Bone Resorption
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Histological Measurement Comparing the density of the new bone formed during socket preservation technique using a Mixture of Anorganic Bovine Bone(ABB) And Autogenous Particulate vs a Mixture of Injectable Platelets Rich Fibers, ABB And Autogenous Particulates (sticky bone). radiographical measurements of the amount of bone dimensions changes in socket preservation technique in 6-month period using a Mixture Of Anorganic Bovine Bone(ABB) And Autogenous Particulate vs a Mixture Of Injectable Platelets Rich Fibers, ABB And Autogenous Particulates (sticky bone)


Eligibility criteria: Inclusion Criteria:

* Adult patients with hopeless mandibular molars indicated for extraction and implant placement in two stages that indicate socket preservation.
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Presence of fenestrations or dehiscence of the residual bony Walls after extraction.
* Heavy smokers more than 20 cigarettes per day .(24)
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
* Patients that refuse to be called back for implant placement post extraction.
* Patients that have exceeded bone resorption surrounding the tooth prior to extraction and require guided bone regeneration.

Primary outcomes:
measure: histomorphometrical bone quality
timeFrame: 6 month
Secondary outcomes:
measure: marginal bone loss
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01646697: Slide Interpretation or Standard Surgical Pathology in Assessing Margin Status in Patients With Pancreatic Cancer Undergoing Surgery
Official title: Cytopathologic Margin Evaluation in Patients Undergoing Pancreatic Cancer Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Adenocarcinoma
Keywords: pancreatic cancer
adenocarcinoma
pancreatic resection
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done to investigate another way of evaluating margin status after pancreatectomy by using cytopathology (slide interpretation) as compared to the traditional method of surgical pathology

Detailed description: PRIMARY OBJECTIVES:

I. To compare margin status on final pathology with margin status from cytopathologic evaluation.

OUTLINE:

Patients undergo cytopathologic sample collection during pancreatic resection during which slides are gently pressed against the cut edge of the pancreas, the surgical bed, and along the superior mesenteric artery, and finally against the tumor itself.

Eligibility criteria: Inclusion Criteria:

* patients undergoing pancreatic resection for a presumed, although not necessarily biopsy-proven pancreatic malignancy,
* ages 18 years to 80 years old

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: Local recurrence at the site of resection
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Mark Bloomston, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05406297: Impact of TMAO Serum Levels on Hyperemic IMR in STEMI Patients
Official title: Impact of Trimethylamine N-oxide (TMAO) Serum Levels on Index of Microcirculatory Resistance (IMR) in Patients Diagnosed With ST-Elevation Myocardial Infarction (STEMI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: STEMI - ST Elevation Myocardial Infarction
Microvascular Coronary Artery Disease
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Brescia
name: Kreiskrankenhaus Rotenburg
First posted: 2022-06-06
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a prospective, cohort study, conducted in the Hospital of the Lithuanian University of Health Sciences Kaunas Clinics.

Brief summary: Trimethylamine N-oxide (TMAO) is a gut microbiota-dependent metabolite of dietary choline, L-carnitine, and phosphatidylcholine-rich foods. On the basis of experimental studies and patients with prevalent disease, elevated plasma TMAO may increase risk of atherosclerotic cardiovascular disease (ASCVD). However, to our knowledge, no data is available on its impact on coronary microcirculation.


Eligibility criteria: Inclusion Criteria:

1. Patient diagnosed with STEMI
2. Availability of non- left anterior descending artery (LAD) non culprit lesion, which is planned for a staged Percutaneous coronary intervention (PCI)

Exclusion Criteria:

1. patient undergoing cardiopulmonary resuscitation;
2. patients with a history of old myocardial infarction or history of coronary artery bypass grafting (CABG) or Percutaneous coronary intervention PCI
3. Patients with signs of chronic infection, prolong usage of corticosteroids or compromised immune system
4. patients had thrombolysis before primary Percutaneous coronary intervention (pPCI)
5. had contraindication of adenosine triphosphate (ATP);
6. had a history of liver or renal function dysfunction
7. Patients with dementia
8. Patients being referred to CABG after primary PCI
9. unable to provide informed consent;
10. had pregnancy or life span \< 1 year.
11. Presence of sever structural valvular heart disease
12. Presence of significant left main disease
13. Unability to measure the index of microcirculatory resistance due to (death or retraction from the study ...etc)
14. Inability to perform successful PCI

Primary outcomes:
measure: Index of microcirculatory resistance
timeFrame: 3 months
Secondary outcomes:
measure: Left ventricular ejection fraction
timeFrame: 3 months
measure: major adverse cardiovascular events (MACE)
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Ali Aldujeli
Study officials:
References:
Clinical trial NCT05165797: Platelet Activation Affecting the Rate of Vascular Access Patency
Official title: Platelet Activation Affecting the Rate of Vascular Access Patency; Single Center, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Platelet Activation
Hemodialysis Fistula Thrombosis
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing dialysis access route formation for the purpose of hemodialysis at this institution

Brief summary: In the case of cardiovascular diseases such as coronary artery disease, cerebrovascular disease, and peripheral arterial disease, there are many studies that the use of antiplatelet agents is very helpful in improving the vascular patency rate, but there are not many studies on the use of antiplatelet agents in the dialysis approach. The basis for use is insufficient. There is a lack of research on whether maintaining a state in which platelet activation is suppressed is helpful in improving dialysis access patency. Therefore, we conducted this study to determine whether the degree of platelet activation affects the patency of vascular access.


Eligibility criteria: Inclusion Criteria:

* Patients 19 years of age or older who are undergoing hemodialysis during renal replacement therapy
* Patients undergoing arteriovenous fistula formation and hemodialysis to the affected area
* Patients who have the ability and willingness to consent to participate in the clinical study, have signed the consent form in accordance with the appropriate procedures, and can visit and participate in the clinical study as planned

Exclusion Criteria:

* Patients who failed to start hemodialysis with an arteriovenous fistula within 3 months
* Patients who have had stent implantation or surgery during the study period due to cardiovascular disease
* Patients with severe hepatic impairment
* Patients with coagulopathy and liver disease associated with clinically significant bleeding risk
* Patients with clinically significant bleeding or bleeding risk
* Patients who underwent artificial heart valve replacement requiring anticoagulant administration
* Patients with pulmonary embolism who are hemodynamically unstable or require thrombolysis or pulmonary embolization.
* Pregnant and lactating women

Primary outcomes:
measure: Vascular access primary patency
timeFrame: 1 month
Secondary outcomes:
measure: Vascular access secondary patency
timeFrame: 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea university anam hospital
state: Non US/Canada
Study officials:
References:
Clinical trial NCT01423097: Magnitude of Osteoarthritis disadVantage on pEoples liveS
Official title: Magnitude of Osteoarthritis disadVantage on pEoples liveS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: osteoarthritis symptoms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-08-25
Enrollment: 1015
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: community sample

Brief summary: Estimate the prevalence of self-reported osteoarthritis and its characterization in adults over 45 years of age:

* Characterization of self-reported patients with OA (socio-demographic, comorbidities, VAS for intensity of pain)
* Characterization of OA diagnosis in patients with self-reported OA
* Impact of self-reported OA in the working abilities, quality of life and functionality (SF-12 v2.0)
* Characterization of treatment approaches (therapeutic and non-therapeutic) for self-reported patients with OA
* Patient perception of impact of OA in its life and importance given to disease

Detailed description: Magnitude of Osteoarthritis disadvantage on peoples lives.

Eligibility criteria: Inclusion Criteria:

- Adults over 45 years old with self-reported osteoarthritis

Exclusion Criteria:

- NA

Primary outcomes:
measure: Estimate the prevalence of self-reported osteoarthritis (OA) in adults over 45 years of age by direct interview.
timeFrame: Single interview at the only one patient contact
Secondary outcomes:
measure: Characterization of self-reported patients with OA by collecting socio-demographic information through direct interview.
timeFrame: Single interview at the only one patient contact
measure: Characterization of self-reported patients with OA by collecting comorbidities information through direct interview.
timeFrame: Single interview at the only one patient contact
measure: Characterization of self-reported patients with OA by collecting information for intensity of pain through direct interview.
timeFrame: Single interview at the only one patient contact
measure: Characterization of OA diagnosis in patients with self-reported OA by direct interview.
timeFrame: Single interview at the only one patient contact
measure: Impact of self-reported OA in the working abilities, quality of life and functionality using Questionnaire SF-12 v2.0
timeFrame: Single interview at the only one patient contact
measure: Patient perception of impact of OA in its life and importance given to disease by direct interview.
timeFrame: Single interview at the only one patient contact
Other outcomes:
Locations:
city: Queluz Baixo
country: Portugal
facility: Research Site
state: Barcarena
Study officials:
References:
Clinical trial NCT04645797: A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions
Official title: A Phase 1 Dose Escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics/ Pharmacodynamics of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Colorectal Carcinoma
Lead sponsor: Apros Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2020-11-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Phase 1 Dose Escalation
Primary purpose: TREATMENT

Brief summary: A Phase 1 dose escalation study to evaluate APR003 in patients with advanced colorectal cancer (CRC) with malignant liver lesions

Detailed description: APR003 is a small molecule TLR7 agonist that concentrates in the GI, and liver with limited systemic exposure. It is designed to increase the therapeutic window of a TLR7 agonist by minimizing the side-effects associated with generalized systemic immune activation and inflammation.

Eligibility criteria: Inclusion Criteria:

* ECOG performance status of 0 or 1
* Must have disease that is considered non-surgically resectable.
* Relapsed or persistent/refractory to at least two prior systemic treatment regimens for locally advanced or metastatic disease considered to be standard-of-care (SOC).
* Must have previously received an irinotecan or oxaliplatin-based therapy, as well as a targeted antibody therapy for metastatic disease
* Tumors that are MSI-H/dMMR must have previously received checkpoint inhibitor therapy
* Adequate hepatic function
* Adequate renal function
* Normal coagulation panel
* Willingness to use effective contraception

Exclusion Criteria:

* Current or history of CNS metastases
* Significant cardiovascular disease
* Pregnant or breastfeeding

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: Up to one year
Secondary outcomes:
measure: Secondary Outcome
timeFrame: Up to three years
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Huntersville
country: United States
facility: Carolina BioOncology Institute Cancer Research Clinic
state: North Carolina
city: Austin
country: United States
facility: NEXT Oncology - Austin
state: Texas
city: San Antonio
country: United States
facility: NEXT Oncology - San Antonio
state: Texas
Study officials:
affiliation: Apros Therapeutics, Inc
name: Aaron Weitzman, MD
role: STUDY_DIRECTOR
affiliation: Apros Therapeutics, Inc
name: Trinh Le
role: STUDY_DIRECTOR
References:
Clinical trial NCT02460497: Minoxidil 2% Solution and Botanical Hair Regimen in Women With Thinning Hair and Female Pattern Hair Loss/Androgenic Alopecia
Official title: Multicenter, Open Label Clinical Trial to Evaluate the Effect and Tolerability of Minoxidil 2% Solution and Botanical Hair Solution Regimen in Women With Thinning Hair and Female Pattern Hair Loss/Androgenic Alopecia (Ludwig I and II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Pattern Hair Loss, Androgenic Alopecia
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2015-06-02
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the effect of Minoxidil 2% Solution and Botanical Hair Solution Regimen in women with thinning hair and female pattern hair loss/androgenic alopecia (Ludwig I and II).


Eligibility criteria: Key Inclusion Criteria:

1. Female patients age 18 to 60 years at the time of enrollment.
2. Women who have self-perceived thinning hair.
3. Women who have presentation of female pattern hair loss/androgenic alopecia (Ludwig I and II).

Key Exclusion Criteria:

1. History of allergic reactions or severe intolerance to minoxidil and Botanical Hair Solution product ingredients.
2. Plan to use any other concomitant therapy to treat hair loss, regrowth or volume during the study.

3 Subjects taking or planning to take topical or systemic prescription or OTC medications for treating hair loss and/or hair volume.

4. Any significant history of concurrent medical disease, which in the judgment of the Investigator, would make the subject inappropriate for entry to this study including history of skin disease that may confound study results.

5. Subjects who have recently (within the last 6 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study.

6. Pregnant or breast-feeding females or women planning to become pregnant during the course of the study

Primary outcomes:
measure: Change From Baseline in Investigator's Rating of Global Photographs at Week 12
timeFrame: At Week 12
Secondary outcomes:
measure: Change From Baseline in Participant Rating at Week 12
timeFrame: At Week 12
measure: Mean Change From Baseline in Shed Hair Count
timeFrame: At Week 12
measure: Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire
timeFrame: At Week 4, 6 and 12
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From start of study drug administration up to Week 12
Other outcomes:
Locations:
city: Richardson
country: United States
facility: Stephens & Associates
state: Texas
Study officials:
References: