louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04307810: Parent Predicting of Their Child Behavior During Their First Dental Examination
Official title: Parental Expectation for Their Child Behavior in a Group of Children With Primary Dentition During Their First Dental Examination
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Behavior
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 170
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with primary dentition

Brief summary: The aim of this study is to assess the parental expectation for their child behavior in a group of children with primary dentition during their first dental examination

Detailed description: Assessment of children based on their behavior is one of the most important skills for a pediatric dentist. The major aspect of child management in the dental care is managing dental anxiety and fear as it is considered to be the main barrier for successful completion of dental treatment.

Dental anxiety is a common problem which develops mostly in childhood and adolescence. It can have major implications for the child, dental team, and dental services. Providing treatment for the child with dental anxiety can be time-consuming, costly, and demanding for the clinician.

Previous studies have shown that a majority of children with dental anxiety present behavior management problems (BMP) in dental treatment situations. Evaluating a child's level of anxiety before pediatric treatment is the key, since this anxiety is closely related to their behavior during dental visits. Therefore, predicting the behavior is a basic requirement to reduce child's negative attitude during treatment.

Many behavior rating scales are available to assess and evaluate the behavior of a child on each dental visit. Frankl et al classified child's behavior into four groups according to the child's attitude and cooperation or lack of cooperation during dental treatment. This classification is known as Frankl behavior rating scale, which is one of the most reliable tools developed for behavior rating of children in dental sittings.

Eligibility criteria: Inclusion Criteria:

1. Child with Primary dentition
2. First dental visit.
3. Parents of children who agree to fill the questionnaire.

Exclusion Criteria:

1. Child with dental emergency
2. Child with psychological problem
3. Child with chronic illness

Primary outcomes:
measure: Parental expectation for their child behavior
timeFrame: 1 year
Secondary outcomes:
measure: Child behavior
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02676310: Safety, Tolerability, and Pharmacokinetics of Bimatoprost in Men With Androgenetic Alopecia (AGA)
Official title: Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Bimatoprost Topical Solution in the Treatment of Androgenetic Alopecia in Men
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Alopecia
Alopecia, Androgenetic
Baldness
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-02-08
Enrollment: 53
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients with androgenetic alopecia (AGA).


Eligibility criteria: Inclusion Criteria:

* Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year

Exclusion Criteria:

* History of Paget's disease, osteoporosis, or bone malignancy
* History of bone fracture within the previous 12 months, except for metatarsal, metacarpal, or skull fractures
* Patient is currently undergoing radiation therapy or anticipates undergoing radiation therapy at any time during the study
* Drug or alcohol abuse within 12 months
* HIV positive
* Received hair transplants or had scalp reductions
* Use of hair weaves, hair extensions or wigs within 3 months
* Application of topical medications, minoxidil or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks

Primary outcomes:
measure: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: 42 Days
measure: Change from Baseline in Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale
timeFrame: Baseline, 42 Days
measure: Maximum plasma level (Cmax) of bimatoprost and its acid metabolite
timeFrame: 31 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: DermResearch, LLC
state: Texas
city: College Station
country: United States
facility: J&S Studies Inc.
state: Texas
city: Lynchburg
country: United States
facility: E&R Research Foundation
state: Virginia
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02233010: Usefulness of Neutrophil Gelatinase-associated Lipocalin(NGAL) to Confirm Acute Kidney Function Decrease of the Patients Who Had Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2014-09-08
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 43 patients who had non-cardiac surgery in Seoul Paik Hospital.

Brief summary: Although post-op renal function decrease is determined by serum creatinine, serum creatinine has disadvantages that it increases a long time after renal function decrease and it has various increasing time based on the level of renal function. Neutrophil Gelatinase-associated Lipocalin (NGAL's) usefulness as an evidence for acute kidney damage occurring from post-op cardiac surgery, being critical patients and contrast medium use is already proven.

But NGAL's usefulness for renal function after non-cardiac surgery is not proven and especially, NGAL's usefulness for renal injury after non-cardiac surgery in chronic renal disease patients is not proven.Therefore, the investigators will study about renal function decrease after non-cardiac surgery with NGAL and serum creatinine.


Eligibility criteria: Inclusion Criteria:

* 43 patients who had non-cardiac surgery in Seoul Paik Hospital.

Exclusion Criteria:

* have viral hepatitis and Aspartate aminotransferase, Alanine aminotransferase \> 2 time of normal level
* severe lung disease
* severe heart failure ( Ejection Fraction \< 40% )
* pregnancy

Primary outcomes:
measure: serum NGAL level
timeFrame: up to post operation 12 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00012610: Efficacy of Telepsychiatry in the Treatment of Depression
Official title: Efficacy of Telepsychiatry in the Treatment of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 119
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Telepsychiatry is a novel means of providing expert psychiatric treatment to patients who live far from a source of care. If it can be demonstrated that treatment via telepsychiatry is as effective as in-person treatment, then many individuals with psychiatric illness will have easy access to psychiatric care, even if they live in geographically remote areas.

Detailed description: Background:

Telepsychiatry is a novel means of providing expert psychiatric treatment to patients who live far from a source of care. If it can be demonstrated that treatment via telepsychiatry is as effective as in-person treatment, then many individuals with psychiatric illness will have easy access to psychiatric care, even if they live in geographically remote areas.

Objectives:

The major goal of this study was to determine whether treatment of depressive disorders via telepsychiatry is as effective as in-person treatment. In addition, this study was designed to determine if depressed patients are as compliant and as satisfied with telepsychiatry as with in-person treatment. Another goal was to compare the cost and cost-effectiveness of remote treatment via telepsychiatry to in-person treatment.

Methods:

In this randomized controlled trial, veterans who presented with depression to any of three VA Maryland Health Care facilities with a SCID-IV depression diagnosis and a Hamilton Rating Scale for Depression (Ham-D) score of 16 or above were eligible for participation. Eligible veterans were randomized to either "in-person" treatment or "remote" treatment. Treatment occurred over six months and consisted of psychotropic medication and psycho-education concerning the disease, medications, and side effects. The major outcome variables included changes in Ham-D depression ratings and Beck Depression Inventory (BDI) self-reported depression ratings.

Status:

Completed.

Eligibility criteria: Inclusion Criteria:

Depression, Hamilton 16 or above, SCID-IV depression diagnosis

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Paul E. Ruskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04316910: Characterisation of Gut Microbiota in Patients Undergoing Gastrointestinal Surgery With Postoperative Delirium (GIM-POD)
Official title: Characterisation of Gut Microbiota in Patients Undergoing Gastrointestinal Surgery With Postoperative Delirium (GIM-POD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Delirium
Gut Microbiota
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients Undergoing Gastrointestinal Surgery

Brief summary: The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups depending on whether postoperative delirium or not. This study aims to characterise the gut microbiota in patients undergoing gastrointestinal surgery with postoperative delirium. The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment.

Detailed description: The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups depending on whether postoperative delirium or not. This study aims to characterise the gut microbiota in patients undergoing gastrointestinal surgery with postoperative delirium. The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment.

General anesthesia was induced as follows: 0.3 mg kg-1 intravenous (IV) etomidate, 2 mg IV midazolam, 0.4 μg kg-1 IV sufentanil, and 0.2 mg kg-1 IV cisatracurium. Anesthesia was maintained with an end-tidal concentration of 2-3 vol% sevoflurane and 0.2-0.3 μg kg-1h-1 sufentanil to maintain the bispectral index between 40 and 60.

Eligibility criteria: Inclusion Criteria:

* 1. ethnic Chinese;
* 2. age, 18 to 80 years old;
* 3. American Society of Anaesthesiologists (ASA) physical status I or II;
* 4. required Gastrointestinal Surgery

Exclusion Criteria:

* Cognitive difficulties
* Partial or complete gastrectomy
* Previous esophageal surgery
* Previous treated by radiotherapy or surgery
* Inability to conform to the study's requirements
* Deprivation of a right to decide by an administrative or juridical entity
* Ongoing participation or participation in another study \<1 month ago

Primary outcomes:
measure: Characterisation of Gut Microbiota
timeFrame: from baseline to postoperative 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
References:
Clinical trial NCT02353910: VTE Incidence in Severe Sepsis and Septic Shock
Official title: VTE Incidence and Risk Factors in Patients With Severe Sepsis and Septic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Sepsis With Septic Shock
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2015-02-03
Enrollment: 113
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We prospectively studied 113 consecutively enrolled ICU patients with severe sepsis and septic shock admitted at three hospitals. All patients provided informed consent and this study was IRB approved. VTE thromboprophylaxis was recorded for all patients. Patients underwent bilateral lower (and upper, if a central venous catheter \[CVC\] was present) comprehensive compression ultrasonography (CUS) and were followed for symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) prior to discharge. We performed multivariate regression analyses to identify predictors of VTE

Brief summary: Prospective studies on the incidence of VTE during severe sepsis and septic shock remain absent, hindering efficacy assessments regarding current VTE prevention strategies in septic patients. The investigators will prospectively study consecutively enrolled ICU patients with severe sepsis and septic shock admitted at three hospitals. All patients will provide informed consent and the study will be IRB approved. VTE thromboprophylaxis, provided per standard of care and according to the patients' primary team, will be recorded for all patients. Patients will undergo bilateral lower (and upper, if a central venous catheter \[CVC\] was present) comprehensive compression ultrasonography (CUS) and will be followed for symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) prior to discharge. The investigators will perform multivariate regression analyses to identify predictors of VTE.


Eligibility criteria: Inclusion Criteria:

* ICU patients with severe sepsis and septic shock

Exclusion Criteria:

* Admission diagnosis of acute VTE,
* age \< 13 years,
* pregnancy,
* severe chronic respiratory disease,
* severe chronic liver disease (Child-Pugh Score of 11-15),
* moribund patients not expected to survive 24 hours, and
* acute myocardial infarction within 30 days.

Primary outcomes:
measure: Incidence of VTE
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kaplan D, Casper TC, Elliott CG, Men S, Pendleton RC, Kraiss LW, Weyrich AS, Grissom CK, Zimmerman GA, Rondina MT. VTE Incidence and Risk Factors in Patients With Severe Sepsis and Septic Shock. Chest. 2015 Nov;148(5):1224-1230. doi: 10.1378/chest.15-0287.
Clinical trial NCT06073210: Mental Practice and Therapeutic Exercise in Young Nulliparous Women
Official title: Mental Practice and Therapeutic Exercise in Young Nulliparous Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Therapeutic Exercise
Motor Imagery
Action Observation
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mental practice (both in isolation and also in combination with real practice) has been shown to improve somatosensory and motor variables but so far no study has taken it into the study of women's health. Through this study we want to offer some interesting data regarding the effectiveness of mental practice combined with physical practice.


Eligibility criteria: Inclusion Criteria:

* over 18 years of age and asymptomatic women.

Exclusion Criteria:

* This study will exclude those who presented a respiratory pathology, cardiac, systematic, or metabolic disease, history of recent surgery, vertebral fracture, or osteoarticular disorders of the spine area.

Primary outcomes:
measure: Pelvic Floor Muscle Strength
timeFrame: pre-intervention (T0), and inmmediate post-intervention (T1) (between the first and the second measurement, about 60 minutes have elapsed because it is done on the same day).
measure: Pain Pressure Threshold
timeFrame: pre-intervention (T0), and inmmediate post-intervention (T1) (between the first and the second measurement, about 60 minutes have elapsed because it is done on the same day).
measure: Lumbopelvic Motor Control
timeFrame: pre-intervention (T0), and inmmediate post-intervention (T1) (between the first and the second measurement, about 60 minutes have elapsed because it is done on the same day).
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Ferran Cuenca Martínez
Study officials:
References:
Clinical trial NCT01137110: Short Duration Levetiracetam to Extended Course for Seizure Prophylaxis After aSAH
Official title: Comparison of Short Duration Levetiracetam to Extended Course Levetiracetam for Seizure Prophylaxis Following Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subarachnoid Hemorrhage
Keywords: Subarachnoid Hemorrhage
Seizure Prophylaxis
Levetiracetam
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2010-06-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Our primary objective is to compare two treatment options for prevention of seizures following a subarachnoid hemorrhage and determine if a short-course regimen of levetiracetam is as efficacious in the prevention of in-hospital seizures when compared to an extended course.

Detailed description: This is a prospective, single-center, randomized, controlled trial. Patients admitted with spontaneous SAH (and meet enrollment criteria) will be randomized to either levetiracetam 1000 mg twice daily for 3 days or levetiracetam 1000mg twice daily until hospital discharge.

Eligibility criteria: Inclusion Criteria:

1. Age \>18 years of age
2. Diagnosis of spontaneous SAH

Exclusion Criteria:

1. SAH secondary to trauma or arteriovenous malformation
2. Early death (defined as death within 3 days of presentation)
3. Known allergy to levetiracetam
4. Know seizure history on chronic AEDs
5. Pregnancy
6. Current incarceration

Primary outcomes:
measure: In-hospital Seizures
timeFrame: from hospital admission to hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-jewish Hospital
state: Missouri
Study officials:
affiliation: Barnes-Jewish Hospital, Washington University
name: Theresa Human-Murphy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06042010: Oral Zinc Supplement as Adjunctive Therapy for Erosive Oral Lichen Planus
Official title: Efficacy of Oral Zinc Supplement as an Adjunctive Therapy for Erosive Oral Lichen Planus (a Randomized, Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Lichen Planus
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 22
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lichen Planus (LP) is a chronic mucocutaneous inflammatory disease and considered as T-cell mediated autoimmune disorder.

Zinc is a potent antioxidant micronutrient that contributes to the proper functioning of the antioxidant defense system. In addition, this mineral protects cells against inflammation by oxidative stress, because it acts in the stabilization of cell membrane. It also maintains macrophage and neutrophil functions, natural killer cell activity, and complement activity.

Matrix metalloproteinases (MMPs) are a family of zinc-containing endopeptidases and have the main function of proteolytic degradation of connective tissue matrix proteins. Zinc prevents (MMP-1) activation and inhibition of the T-cell accumulation in (OLP) through inhibiting of (MMP-9).

Aim of the study: To evaluate and compare the efficacy of adding oral zinc supplementation 50 mg to 0.1%Triamcinolone orabase (TA)versus 0.1%Triamcinolone orabase alone on the healing of erosive OLP.


Eligibility criteria: Inclusion Criteria:

* All patients involved in this clinical trial will have symptomatic OLP

Exclusion Criteria:

* Smokers or tobacco users will be excluded from this clinical trial.
* Pregnant and lactating females.
* Any patient that has history of cancer, kidney, liver or other autoimmune disease will be excluded from this study.
* Patients showing dysplastic changes in their confirmatory biopsy specimen will be also excluded.
* Any patients presenting with extra oral lichen planus lesions will be excluded.
* Suspicious lesions of both lichenoid contact reaction and lichenoid drug reaction lesions will be excluded.
* Vitamin administration intake within the last 3 months

Primary outcomes:
measure: Change in oral lesions
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in MMP-9 level
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Change in pain
timeFrame: Baseline, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References: