louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03563339: Internet-delivered Postpartum Anxiety Prevention
Official title: Development and Pilot Test of Internet-delivered Postpartum Anxiety Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Disorder
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Postpartum anxiety disorders are the most prevalent postpartum psychiatric conditions. Up to 16% of mothers experience postpartum anxiety or related disorders, such as OCD. With respect to the investigator's own community, this means that up to 3,313 women in West Virginia may struggle with postpartum anxiety or OCD. Left untreated, perinatal anxiety and OCD are associated with numerous adverse outcomes, such as maternal depression, preterm birth, impaired fetal development, low birthweight, difficulty breastfeeding, anxiety in children, and interference with parent-infant bonding. Critically, anxiety is a risk factor for cardiovascular disease and substance use disorders, both significant West Virginia health disparities. Thus, there is a critical need to develop effective and scalable prevention programs to address postpartum anxiety and OCD. The purpose of this proposed community-engaged study is to develop and test the feasibility, usability, and acceptability of an Internet-delivered postpartum anxiety and OCD prevention program, called "Preventing Postpartum Onset Distress", or P-POD.


Eligibility criteria: Inclusion Criteria:

* Female
* Aged 18 or older
* Pregnant with first child
* Married or living with a partner
* State Trait Anxiety Inventory-Trait Total ≥ 44 and/or Obsessive Beliefs Questionnaire-44 Total ≥ 139

Exclusion Criteria:

* past or current anxiety disorders
* past or current OCD
* past or current psychotic disorders
* past or current bipolar disorders
* past or current substance use disorders.

Primary outcomes:
measure: State-Trait Anxiety Inventory-Trait (STAI-Trait)
timeFrame: Change from Baseline to Week 10
measure: Obsessive Beliefs Questionnaire (OBQ-44)
timeFrame: Change from Baseline to Week 10
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Life Sciences Building
state: West Virginia
Study officials:
References:
Clinical trial NCT04459039: Fluid Restriction After Stapled Hemorrhoidopexy
Official title: Do We Need Fluid Restriction After Stapled Hemorrhoidopexy? A Pilot, Double-Blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Restriction
Keywords: Stapled hemorrhoidopexy
Fluid restriction
Urinary retention
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: BACKGROUND: Conventional hemorrhoidectomy leads to a high urinary retention rate and fluid restriction is commonly recommended to minimize complications. However, the need for postoperative fluid restriction among patients who have undergone stapled hemorrhoidopexy is unclear. We aimed to determine whether fluid restriction after stapled hemorrhoidopexy with/without partial external hemorrhoidectomy could reduce urinary retention and postoperative pain.

PATIENTS AND METHODS: In this prospective, double-blinded, randomized controlled trial, we enrolled patients who had grade III or IV hemorrhoids and underwent stapled hemorrhoidopexy with/without partial external hemorrhoidectomy; 250 mL/12 h of sterile 0.9% saline was administered to the fluid restriction group after the operation, and 1000 mL/12 h was given to the non-fluid-restriction group. We focused on the need for fluid restriction after stapled hemorrhoidopexy.


Eligibility criteria: Inclusion Criteria:

* Gr. III-IV hemorrhoids paitents

Exclusion Criteria:

* Age\<20 or \>80
* Allergy to NSAID or opoids
* Impaired renal function
* Pregnant or breast feeding

Primary outcomes:
measure: first urination
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital, National Defense Medical Center
Study officials:
References:
Clinical trial NCT06132139: VisAR Augmented Reality Navigation of Ventriculostomy
Official title: VisAR Augmented Reality Navigation of Ventriculostomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstructive Hydrocephalus
Subarachnoid Hemorrhage
Brain Trauma
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is intended to evaluate the feasibility of using VisAR augmented reality surgical navigation during placement of an external ventricular drain (EVD). The investigators are interested in confirming the design of the VisAR headset is compatible with this bedside procedure.

Detailed description: A secondary objective of this study is to compare the accuracy of freehand EVD navigation, the current standard of care, with VisAR augmented reality surgical navigation. The intent is to demonstrate the advantages to the patient by the use/application of this next generation navigation technology.

Eligibility criteria: Inclusion Criteria:

* Adult patients, 18 years and older, determined to need an external ventricular drain (EVD) or ventriculostomy catheter by the attending neurosurgeon secondary to a variety of pathologies, including obstructive hydrocephalus, trauma and subarachnoid hemorrhage.

Exclusion Criteria:

* Patients less than 18 years of age.
* Pregnant women.
* Prisoners.

Primary outcomes:
measure: Determining navigation system accuracy based on anatomical location and Kakarla scoring system.
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Jennifer Hong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02233439: Double-blind, Placebocontrolled A Randomized Trial on the Efficacy of Herbal Galactogogues
Official title: Efficacy of Herbal Galactogogues: a Double-blinded, Placebo-controlled Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breastfeeding
Keywords: galactagogues
herbs
breastfeeding
supplements
Silybum marianum
Galega officinalis
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
Collaborators: name: Milte Italia SpA
First posted: 2014-09-08
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness of a commercially available product containing a combination of Silybum marianum and Galega officinalis to support continuation or augmentation of breast milk production.


Eligibility criteria: Inclusion Criteria:

* singleton, term delivery
* \>2.5 kg newborn weight
* lactation-deficiency

Exclusion Criteria:

* Neonatal Intensive Care Unit admission
* use of galactagogue drugs
* allergy

Primary outcomes:
measure: Percentage of mothers who exclusively breastfeed their child
timeFrame: At 6 weeks postpartum
Secondary outcomes:
measure: Rate of breastfeeding (either exclusively or as a supplement to formula feeding )
timeFrame: at 6 weeks and 3 months
measure: Volume (mL) and frequency (times a day) of formula
timeFrame: 6 weeks postpartum
measure: weight gain experienced by the newborns
timeFrame: 6 weeks postpartum
measure: serum prolactin level
timeFrame: at baseline and 6 weeks after treatment
measure: Rate of maternal allergic reactions and gastrointestinal side effects
timeFrame: 6 weeks postpartum
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Azienda Ospedaliero-Universitaria Ospedale di Circolo e Fondazione Macchi, Presidio F. Del Ponte
Study officials:
References:
citation: Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database Syst Rev. 2020 May 18;5(5):CD011505. doi: 10.1002/14651858.CD011505.pub2.
Clinical trial NCT00702039: Effect of Music Therapy on Patients Undergoing Intravitreal Injections
Official title: Effect of Music Therapy on Patients Undergoing Intravitreal Injections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intravitreal Injections
Patient Satisfaction
Patient Anxiety
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-06-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving intravitreal injections seen at the Yale Eye Center.

Brief summary: Multiple studies in various specialties, including ophthalmology, are reported in the literature that show that playing music during a procedure (dubbed music therapy) increases patient satisfaction and may reduce patient anxiety and stress levels.

There is no study in the literature that assesses the effects of listening to music in patients undergoing intravitreal injections. This study aims to assess whether listening to music improves patient satisfaction or reduces their anxiety levels in subjects undergoing intravitreal injections.


Eligibility criteria: Inclusion Criteria:

* Those patients at least 18 years old already scheduled for intravitreal injections.

Exclusion Criteria:

* Those patients not interested in participating in the study or not capable of filling out the questionnaire secondary to limited mental capability.
* Non- English speaking subjects will be excluded from the study.
* Those patients that participated in the study will not be allowed to participate a second time.

Primary outcomes:
measure: This study aims to assess what affects music therapy has on patients receiving intravitreal injections. The subject will take a Satisfaction Survey after the procedure and an Anxiety Survey before and after the injection.
timeFrame: Before and after the subject's intravitreal injection.
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Eye Center
state: Connecticut
Study officials:
affiliation: Yale University Department of Ophthalmology
name: Ron Adelman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04652739: Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus
Official title: Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Erosive Lichen Planus
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-12-03
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the effect of oral lycopene and systemic steroids in the treatment of erosive oral lichen planus and compare between the two therapeutic modalities.

Detailed description: Twenty erosive lichen planus patients were recruited and randomly assigned in one of two groups, the test (lycopene) and control (corticosteroids) group.

Eligibility criteria: Inclusion Criteria:

* Erosive oral lichen planus patients with severe and extensive painful erythematous, erosive and/ or ulcerative lesions who are in need for systemic corticosteroid therapy

Exclusion Criteria:

* Pregnant females and smokers.
* Patients suggestive of having lichenoid contact/drug reactions.
* Patients suffering from any systemic disease as diabetes, liver disease, renal disease, any other autoimmune or collagen disease.
* Lesions showing histological features of dysplasia.
* Patients with skin lichen planus lesions.

Primary outcomes:
measure: Pain assessment was conducted using Visual Analogue Scale (VAS)
timeFrame: up to 5 months
measure: Lesion size assessment
timeFrame: up to 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Aliaa A Bedeir, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Azza M Zaki, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Sabah A Mahmoud, PhD
role: STUDY_DIRECTOR
References:
citation: Thongprasom K, Luangjarmekorn L, Sererat T, Taweesap W. Relative efficacy of fluocinolone acetonide compared with triamcinolone acetonide in treatment of oral lichen planus. J Oral Pathol Med. 1992 Nov;21(10):456-8. doi: 10.1111/j.1600-0714.1992.tb00974.x.
citation: Gobbo M, Rupel K, Zoi V, Perinetti G, Ottaviani G, Di Lenarda R, Bevilacqua L, Woo SB, Biasotto M. Scoring systems for Oral Lichen Planus used by differently experienced raters. Med Oral Patol Oral Cir Bucal. 2017 Sep 1;22(5):e562-e571. doi: 10.4317/medoral.21833.
Clinical trial NCT03309839: HLA-DR Expression in Neonates After Cardiac Surgery Under Cardiopulmonary Bypass
Official title: HLA-DR Expression in Neonates After Cardiac Surgery Under Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Keywords: HLA-DR expression
cardiopulmonary bypass
neonate
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Fédération Française de Cardiologie
First posted: 2017-10-16
Enrollment: 50
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged ≤ 28 days after cardiac surgery under cardiopulmonary bypass

Brief summary: The purpose of this study is to determine how monocyte HLA-DR and other markers of immune function change with time in neonates who underwent cardiac surgery with cardiopulmonary bypasss.

We hypothesize that HLA-DR expression in neonates is predictive of septic complications after cardiopulmonary bypass


Eligibility criteria: Inclusion Criteria:

* Patients aged ≤ 28 days
* Admission after cardiac surgery under cardiopulmonary bypass

Exclusion Criteria:

* Lack of parental consent

Primary outcomes:
measure: HLA-DR expression
timeFrame: Preoperatively, and 1, 2, 3 and 4 days after the end of cardiopulmonary bypass
Secondary outcomes:
measure: Cytokines measurements
timeFrame: Preoperatively, and 1, 2, 3 and 4 days after the end of cardiopulmonary bypass
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Alexis Chenouard, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02960139: A Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Technique Plus Sylys® Surgical Sealant
Official title: A Pivotal, Prospective, Randomized, Controlled, Multicenter Superiority Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Technique Plus Sylys® Surgical Sealant
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal and Ileorectal Anastomosis
Lead sponsor: Cohera Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-09
Enrollment: 61
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Cohera Sylys® Surgical Sealant study is a pivotal, prospective, randomized, controlled, multicenter superiority clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) during stapled colorectal and ileorectal anastomosis procedures.


Eligibility criteria: Inclusion Criteria:

* Be at least 22 years of age
* Be scheduled for a stapled colorectal or ileorectal anastomosis procedure with or without diverting stoma
* Agree to return for all follow-up evaluations and procedures specified in the protocol
* Understand and give informed consent

Exclusion Criteria:

* Albumin \< 3
* ASA ≥ 4
* Neutropenia ≤ 800
* Pregnancy
* The following conditions involving compromised immune system: AIDS (HIV positive not excluded), neutropenia
* Known blood clotting disorder requiring treatment
* Any condition known to effect wound healing, such as collagen vascular disease
* Have known or suspected allergy or sensitivity to any test materials or reagents
* Concurrent use of fibrin sealants or other anastomosis care devices
* Surgery for emergency abdominal indications
* Has undergone a colorectal anastomosis procedure in the previous two months
* Has an emergent infection related to a previous colorectal anastomosis procedure
* Is scheduled to undergo a Hartmann's procedure
* Is scheduled to undergo trans-anal endoscopic microsurgery (TEM) Is participating in another medical device trial related to colorectal anastomosis

Primary outcomes:
measure: A comparison of the incidence of anastomosis-related complications
timeFrame: from day of surgery to week 26
Secondary outcomes:
measure: A comparison of the proportion of patients who have incidence of sub-clinical or clinical anastomotic leaks
timeFrame: 14 days, 12 weeks, 26 weeks
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: Flevoziekenhuis
state: Flevoland
city: Amersfoort
country: Netherlands
facility: Meander Medical Center
city: Amsterdam-Zuidoost
country: Netherlands
facility: AMC
city: Amsterdam
country: Netherlands
facility: OLVG
city: Roermond
country: Netherlands
facility: Laurentius
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
Study officials:
References:
Clinical trial NCT01801839: Detection Of Monocytes/Macrophages Function And Tim-3 Expression In Septic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
SIRS(Systemic Inflammatory Response Syndrome)
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects were selected from among inpatients who were hospitalized between August 2012 and March 2013 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.

Brief summary: The imbalance between anti- and pro-inflammation often occurs in patients with sepsis. And continuous such imbalance could lead to immunoparalysis, which is characterized by loss of delayed type hypersensitivity, failure of primary infections eradication, and a predisposition of secondary nosocomial infections development. However, in which phase of sepsis does immunoparalysis occur is still unknown. So this study aims to tentatively understand this problem by checking monocytes/macrophages' antigen presentation and cytokine secretion，and by checking monocytes/macrophages' expression of Tim-3 (the T cell transmembrane, immunoglobulin, and mucin-3), which is an inhibitory regulatory molecule, in sepsis patients' peripheral blood mononuclear cells.


Eligibility criteria: Inclusion Criteria:

* age over 18 years old;
* Fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 ℃ or lower than 36 ℃ (b)respiratory rate above 20/min, or carbon dioxide partial pressure below 32 mmHg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands.
* Clinically suspected infection;

Exclusion Criteria:

* were under 18 years of age;
* were refused by the patients or his/her familiality;
* were suffering from acquired immunodeficiency syndrome,viral hepatitis,autoimmune diseases and hematology;
* use medicine which can affect immune system,such as Glucocorticoid and Immunosuppressant
* died within 24h after being taken into the ICU, or refused to get involved in the study, or gave up treatment during the period of observation

Primary outcomes:
measure: systemic inflammatory response to infection with organ dysfunction, hypoperfusion, or hypotension
timeFrame: within 24 hours after enter experimental group
Secondary outcomes:
Other outcomes:
Locations:
city: Peking
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Respiratory Disease Department of Chinese PLA General Hospital
name: Lixin Xie, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00862186: Self-Management of Cancer-Related Fatigue by Adolescents
Official title: Self-Management of Cancer-Related Fatigue by Adolescents: Pilot Study of an Evidence Based Educational Resource
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Fatigue
Keywords: Neoplasms
Fatigue
Self Care
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Alex's Lemonade Stand Foundation
First posted: 2009-03-16
Enrollment: 15
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will investigate self-management of cancer-related fatigue by adolescents through pilot study of an evidence based educational resource.

Detailed description: Cancer-related fatigue is a prevalent and distressing symptom which has a significant impact on quality of life for children and adolescents with cancer and their families. Evidence based guidelines issued by the Oncology Nursing Society and National Comprehensive Cancer Network recommend educational interventions for preventing and treating cancer-related fatigue.The primary study aim is to examine the relationships among: intensity of cancer-related fatigue; frequency of use of an evidence based educational resource for self-management of cancer-related fatigue; and perceived helpfulness of resource use. The secondary aim is to examine the relationship between the Fatigue Scale-Adolescent (FS-A) and the Symptom Distress Scale (SDS) 'tired' item as measures of intensity of cancer-related fatigue. The tertiary aim is to examine the feasibility of recruiting and retaining adolescents with cancer for longitudinal study of cancer-related fatigue.

Eligibility criteria: Inclusion Criteria:

* adolescents 13-18 years inclusive
* leukemia, lymphoma, or malignant solid tumor; newly diagnosed and within 2 weeks of initiating therapy
* patient and consenting parent able to speak, read, and write English.

Exclusion Criteria:

* failure to meet all of inclusion criteria

Primary outcomes:
measure: Change From Baseline in Fatigue Scale-Adolescent (FS-A) Score Categorized According to 1-5 Rating Scale of Resource Use and Resource Helpfulness.
timeFrame: baseline and weekly up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Catherine Fiona Macpherson, PhD
role: PRINCIPAL_INVESTIGATOR
References: