louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00953017: A Trial Comparing Split-Dose Miralax With Amitiza Pretreatment Versus Dulcolax Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy
Official title: A Randomized, Blinded Trial Comparing Miralax With Amitiza Pretreatment Versus Miralax With Dulcolax Pretreatment Versus Miralax Alone Without Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Keywords: Efficacy of bowel cleansing
Patient tolerability
Amitiza
Dulcolax
Miralax
Colonoscopy preparation
Bowel preparation
Screening colonoscopy
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2009-08-06
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Miralax (PEG 3350) has been shown to be a safe and uncomplicated bowel preparation prior to colonoscopy in pediatric populations. This study seeks to confirm the efficacy of this bowel cleansing regimen in adults and to determine the benefit of adding a pretreatment medication to this bowel preparation. The tolerability of Miralax will hopefully improve patient satisfaction with colonoscopy and decrease their reluctance to be screened because of the uncomfortable taste and side effects of bowel preparation regimens.


Eligibility criteria: Inclusion Criteria:

* adult patients referred to our clinic for average or increased risk screening for colorectal cancer

Exclusion Criteria:

* elevated serum creatinine (Men \>1.4mg/dL, Women \>1.3mg/dL)
* previous diagnosis of congestive heart failure
* history of bowel obstruction
* history of solid organ transplant
* current pregnancy
* lactating mother
* participants allergic to either polyethylene glycol (Miralax), lubiprostone (Amitiza), or bisacodyl (Dulcolax)

Primary outcomes:
measure: The Cleanliness of the Prep as Measured by the Ottawa Scale
timeFrame: measured at the time of colonoscopy
Secondary outcomes:
measure: Patient Satisfaction With the Prep Measured by 5 Point Likert Scale
timeFrame: measured at check in to colonoscopy
measure: Procedure Time
timeFrame: measured at the time of colonoscopy
measure: Polyps Detected
timeFrame: measured at the time of colonoscopy
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
References:
citation: Hjelkrem M, Stengel J, Liu M, Jones DP, Harrison SA. MiraLAX is not as effective as GoLytely in bowel cleansing before screening colonoscopies. Clin Gastroenterol Hepatol. 2011 Apr;9(4):326-332.e1. doi: 10.1016/j.cgh.2010.11.007. Epub 2010 Nov 27.
Clinical trial NCT01305317: Effect of Statins on IgG, IgA and IgM Level in Chronic Hemodialysis Patients
Official title: Study of Statins' Effect on Serum IgG, IgA Ang IgM Level in Chronic Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Statin
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-02-28
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is double blind randomized controlled trial on the statins effects on serum IgG, IgA and IgM level in chronic hemodialysis patients in Bandarabbas

Detailed description: This study is a randomized controlled trial of statins effect on serum IgG, IgA and IgM level on chronic hemodialysis patients in Bandarabbas. The study is carried out in Hormozgan, Iran. Seventy four patient were randomized either to receive atorvastatin in addition of usual treatment or not. The primary outcomes were serum IgG,IgA and IgM level. The secondary outcome was drug side effects.

Eligibility criteria: Inclusion Criteria:

* All chronic hemodialysis patients attending Shahid Mohammadi hospital during the study period
* Accepting to participate in the study

Exclusion Criteria:

* Refusing to participate in the study

Primary outcomes:
measure: Serum IgG, IgA and IgM level
timeFrame: 6 months
Secondary outcomes:
measure: Drug side effects
timeFrame: 6 months
Other outcomes:
Locations:
city: Bandar Abbas
country: Iran, Islamic Republic of
facility: Shahid Mohammadi hospital
state: Hormozgan
Study officials:
affiliation: Hormozgan University of Medical Sciences
name: Hamidreza Mahboobi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01625117: Mental Health and Aggression in Congolese Ex-combatants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Appetitive Aggression
Posttraumatic Stress Disorder
Keywords: Treatment of ex-combatants
Narrative Exposure Therapy for ex-combatants
Appetitive Aggression
Posttraumatic Stress Disorder
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2012-06-21
Enrollment: 38
Sex: MALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is examine, whether a treatment approach, which is specifically tailored for perpetrators who have participated in violence (a variant of Narrative Exposure Therapy) is effective in the reduction of instrumental aggression and symptoms of posttraumatic stress disorder.

Detailed description: The reintegration of former child soldiers and ex-combatants is a big challenge in war-torn countries. Former child soldiers and ex-combatants often suffer from mental health problems and show enhanced levels of aggression. The present study focuses on the reduction of appetitive aggression and the improvement of mental health in former child soldiers and ex-combatants in DR Congo.

Eligibility criteria: Inclusion Criteria:

* Ex-combatants in Congo who live in a re-integration camp

Primary outcomes:
measure: Appetitive aggression (Appetitive Aggression Scale)
timeFrame: 6 months
measure: Symptoms of posttraumatic stress disorder (Posttraumatic Diagnostic Scale, PDS)
timeFrame: 6 months
Secondary outcomes:
measure: Symptoms of depression (Mini-International Neuropsychiatric Interview)
timeFrame: 6 months
measure: Functionality (Work and Social Adjustment Scale)
timeFrame: 6 months
Other outcomes:
Locations:
city: Goma
country: Congo
facility: Reintegration camp for ex-combatants
Study officials:
affiliation: University of Konstanz
name: Thomas Elbert, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01054417: APPEndicitis and Laparoscopic Criteria; APPEL Study
Official title: A Prospective Evaluation to Determine Laparoscopic Criteria for the Diagnosis Appendicitis During a Diagnostic Laparoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendicitis
Keywords: Appendicitis
Laparoscopy
Appendectomy
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2010-01-22
Enrollment: 142
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who will undergo a diagnostic laparoscopy for the clinical diagnosis appendicitis.

Brief summary: A diagnostic laparoscopy is frequently used to confirm the diagnosis of appendicitis. However, laparoscopic criteria for determining appendicitis are not defined. If there is any doubt about the presence of an abnormal appendix, it is usually removed. However, an appendectomy of a negative appendix has a certain morbidity and for that reason it should be avoided. The purpose of this study is to establish laparoscopic criteria for the diagnosis appendicitis during diagnostic laparoscopy.

Detailed description: The UMCG hospital protocol of suspicion of appendicitis includes a diagnostic laparoscopy. The laparoscopic inspection of the appendix is carried out according to a specific protocol. In case of appendicitis the appendix is removed laparoscopically, a normal appendix is not removed. The primary outcome of the study is: appendicitis according to pathologic examination following appendectomy, or appendicitis according to clinical follow-up in case the appendix is not removed.

The clinical diagnosis of appendicitis in the follow-up should be confirmed radiologic examination (ultrasound, CT-scan, MRI) or by a re-operation.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Patients who will undergo a diagnostic laparoscopy for suspicion of appendicitis
* No age or gender limits

Exclusion Criteria:

* Elective scheduled appendectomy
* Unable to give informed consent

Primary outcomes:
measure: Accuracy of appendix characterization by histology or clinically
timeFrame: 3 months
Secondary outcomes:
measure: Readmission
timeFrame: 3 months
measure: Re-operation
timeFrame: 3 months
measure: Intra-abdominal abcess
timeFrame: 3 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen, the Netherlands
name: JW Haveman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00067717: Distance Healing in Wound Healing
Official title: Placebo Effects in Distance Healing of Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Reconstruction Surgery
Keywords: breast reconstruction surgery
prayer
distance healing
wound healing
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2003-08-27
Enrollment: 72
Sex: FEMALE
Minimum age (years): 34
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial examines the impact of patients' knowledge of an experienced distant healer's efforts to heal them on measures of wound healing, psychosocial functioning, and physiological symptoms after plastic surgery.


Eligibility criteria: Inclusion Criteria:

* Women undergoing major plastic surgery (\> 2 hours in length)
* Health status is excellent with no systemic disease, no limitation on activity, no danger of death or disease of one body system, well-controlled underlying disease

Exclusion Criteria:

* Remove history of breast or other cancers
* History of radiation therapy to the abdomen or any radiation within the past three months
* Non-English speaking
* Unable or unwilling to fill out questionnaires
* Current smoker
* Morbid obesity
* Circulatory inadequacies (i.e., diabetes, hypovolemia)
* Nutritional deficits as evidenced by neutropenia (WBC \<2500/ml) or hypoalbuminemia (albumin \<3.3mmg/dl) / chart review

Primary outcomes:
measure: Collagen deposition in a surrogate wound
timeFrame: 8 days
Secondary outcomes:
measure: POMS normalized mood scores
timeFrame: 8 days
Other outcomes:
measure: SF-36 Mental Composite Score
timeFrame: 8 days
measure: SF-36 Physical Composite Score
timeFrame: 8 days
Locations:
city: San Francisco
country: United States
facility: Complementary Medicine Research Institute
state: California
Study officials:
affiliation: California Pacific Medical Center
name: Marilyn J Schlitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schlitz M, Hopf HW, Eskenazi L, Vieten C, Radin D. Distant healing of surgical wounds: an exploratory study. Explore (NY). 2012 Jul-Aug;8(4):223-30. doi: 10.1016/j.explore.2012.04.004.
Clinical trial NCT06948617: Children's Preferences on Digital and Conventional Impression Techniques
Official title: Digital and Conventional Impression Techniques: What Influences Children's Preferences?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Impressions
Keywords: dental impression
digital intraoral scanner
alginate
children
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 131
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this crossover study is to compare children's perceptions and preferences regarding digital and conventional impression techniques in the 5- to 11-year-old age group. The main questions it aims to answer are

* Which impression methods do kids prefer?
* What influences kids' perception of impression methods?

Dental impressions will be obtained using both the conventional alginate impression (CAI) (Cavex ColorChange; Cavex Holland BV, Haarlem, the Netherlands) and digital intraoral scanning procedure (DIS) (3Shape TRIOS Color, 3Shape, Copenhagen, Denmark). After each procedure, patients will score their perceptions using a Modified Impression Perception Test, a 5-point Likert scale, for gag reflex, queasiness, difficulty breathing, uncomfortable feeling, pain perception, chairside time, and stress levels. Dental anxiety will be assessed using the Visual Anxiety Scale (1-10). Children will also be asked about their preferences and reasons in one or two sentences. Content analysis will be performed on answers to open-ended questions. Statistical analysis will be done using Fisher's Exact test.


Eligibility criteria: Inclusion Criteria:

* No prior exposure to either digital or conventional impression techniques
* Absence of temporomandibular joint disorders and periodontal disease
* Cleft lip and/or palate, or other significant craniofacial anomalies
* No current use of psychiatric or neuropathic medications

Exclusion Criteria:

* Individuals with a known history of dental anxiety or a pronounced gag reflex

Primary outcomes:
measure: Modified Children Perception test
timeFrame: one year
Secondary outcomes:
measure: Responses to open-ended questions
timeFrame: one year
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Usak University School of Dentistry, Department of Pediatric Dentistry
Study officials:
References:
citation: Yilmaz H, Aydin MN. Digital versus conventional impression method in children: Comfort, preference and time. Int J Paediatr Dent. 2019 Nov;29(6):728-735. doi: 10.1111/ipd.12566. Epub 2019 Aug 13.
Clinical trial NCT00561717: A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis
Official title: A Four-Way Double-Blind, Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of Azelastine Nasal Spray and Antihistaminic Agents in Adult Subjects With Allergen Induced Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Allergic Rhinitis
Keywords: Seasonal Allergic Rhinitis
Ragweed
Pollen
Allergy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Kingston Health Sciences Centre
First posted: 2007-11-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Finding out how fast azelastine nasal spray works in subjects with hay fever.


Eligibility criteria: Inclusion Criteria:

* History of seasonal allergic rhinitis to ragweed pollen for last 2 consecutive seasons;
* Positive response to skin prick test to ragweed allergen at screening;
* Be willing to participate in the trial.

Exclusion Criteria:

* History of hypersensitivity to azelastine;
* Females who are pregnant or lactating;
* Relative chronic sinusitis or nasal structural abnormalities causing greater than 50% obstruction;
* Asthma that requires other than occasional use of inhaled short-acting beta-2 antagonist;
* Known non-responsiveness to antihistamines;
* Alcoholism or drug abuse within 2 yrs. of screening;
* Current or regular use within 6 months of any type of tobacco product;
* Evidence of any clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or malignancies within the last 5 years;
* History of a positive test to HIV, TB, hepatitis B or C.

Primary outcomes:
measure: Onset of action measured by change in total nasal symptom score Until "Onset of action" = until drug demonstrates and maintains a change greater than placebo compared to baseline
timeFrame: Up to 6 hours
Secondary outcomes:
measure: Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy
timeFrame: Effect over 6 hours
Other outcomes:
Locations:
city: Kingston
country: Canada
state: Ontario
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Tenn MW, Steacy LM, Ng CC, Ellis AK. Onset of action for loratadine tablets for the symptomatic control of seasonal allergic rhinitis in adults challenged with ragweed pollen in the Environmental Exposure Unit: a post hoc analysis of total symptom score. Allergy Asthma Clin Immunol. 2018 Jan 16;14:5. doi: 10.1186/s13223-017-0227-4. eCollection 2018.
Clinical trial NCT05765617: Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients
Official title: Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: calcitriol, HsCRP
Lead sponsor: Universitas Sebelas Maret
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This research was an observational analytic cohort retrospective study in which the subjects were moderate degree COVID-19 inpatients in Sebelas Maret University Hospital divided into two groups. The control group received standard therapy, while the treatment group received calcitriol 2x400 iu per day.
Primary purpose: TREATMENT

Brief summary: This research is a study that compares the administration of calcitriol with the outcomes of COVID-19 patients

Detailed description: This research was an observational analytic cohort retrospective study in which the subjects were moderate degree COVID-19 inpatients in Sebelas Maret University Hospital divided into two groups. The control group received standard therapy, while the treatment group received calcitriol 2x400 iu per day.

Eligibility criteria: Inclusion Criteria:

* COVID-19 patients, hospitalized patients, and patients aged 18-60 years

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: HsCRP
timeFrame: Hs CRP (high sensitive c reactive protein) examination was carried out on the first day of hospitalization and the 5th day of hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Sukoharjo
country: Indonesia
facility: Universitas Sebelas Maret Hospital
state: Central Java
Study officials:
affiliation: Universitas Sebelas Maret
name: Nurhasan Agung Prabowo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05055817: a Clinical Risk Score to Predict Bloody Stool in Neonates
Official title: Development and Validation of a Clinical Risk Score to Predict the Occurrence of Bloody Stool in Hospitalized Neonates in Non-neonatal Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Bloody Stool
Necrotizing Enterocolitis
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Chongqing Medical University
First posted: 2021-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: neonates with more than or equal to 35 weeks' GA and less than or equal to 28 days in non-neonatal intensive care unit ward are included.

Brief summary: Bloody stool is a main focus in non-neonatal intensive care unit ward, and it is one of the risk factors in neonates with subsequent necrotizing enterocolitis(NEC) and usually lead to longed duration of hospitalization.

NEC is one of the most serious disease in the newborn infants, and two and more grades of NEC might lead to surgery, even death. But, it is difficult to predict when the bloody stool comes and develop to two and more grades of NEC.

Detailed description: NEC is characterized by vomit, abdominal distention, hypoactive bowel sounds and bloody stools, even shock, disseminated intravascular coagulation(DIC) and sepsis. X-ray is shown Intestinal wall gas and/or portal vein pneumatosis and pneumoperitoneum.

Bloody stool in newborn infant is a urgent condition, and neonatologist usually need to predict whether or not two and more grades of NEC it is.

Here, the investigators will develop a score system in one retrospective cohort to predict bloody stool, and the score system is validated in another prospective cohort.

Eligibility criteria: Inclusion Criteria:

* more than or equal to 35 weeks' gestational age(GA)
* less than or equal to 28 days
* non-neonatal intensive care unit ward

Exclusion Criteria:

* parents' rejection
* main congenital malformation

Primary outcomes:
measure: a Clinical Risk Score
timeFrame: up to 28 days or discharge from hospital
measure: validation of a Clinical Risk Score
timeFrame: up to 28 days or discharge from hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References: