louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06860958: Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients
Official title: Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Depressive Disorder, Major
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Major depressive disorder (MDD) is one of the most common psychiatric disorders with serious socioeconomic consequences on daily life and health care costs. Despite the advent of newer antidepressants that target monoamine pathways, nearly 50% of patients have no response to first-line antidepressant therapy. Thus, a combination of medications with different strategies at the beginning of treatment could provide further therapeutic benefits to MDD patients


Eligibility criteria: Inclusion Criteria:

1. Patients with age greater than 18 years old.
2. Patients with Ham-D score at least 18 with item 1 depressed mood scored 2 or greater are eligible.

Exclusion Criteria:

1. Patients with bipolar I or bipolar II disorder; eating disorders, personality disorders, and mental retardation, current diagnosis anxiety disorders (except for specific phobia), mental disorder due to general medical condition; met criteria for substance dependence or abuse in the previous three months; have a concurrent medical illness or history of seizures that would contraindicate use of the study medication and are receiving Electroconvulsive therapy (ECT).
2. Pregnant women or women not using medically accepted means of birth control are excluded.
3. Persons who score greater than 2 on the suicide item of the Ham-D, or who are judged to have significant suicidal ideation or potential in the view of an investigator, are excluded.
4. Patients who are required to be free of all psychotropic except for escitalopram and anti-inflammatory medications for at least four weeks before study entry.

Primary outcomes:
measure: The principal measure of the outcome will be the 17-item Ham-D
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta Unuversity
Study officials:
References:
Clinical trial NCT03571958: Brief Motivational Interviewing (BMI)
Official title: Impact of Brief Motivational Interviewing During Continuous Patient Care to Enhance Oral Hygiene
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motivational Interviewing, BMI, OHI
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this research study is to determine if the utilization of brief motivational interviewing (BMI) during continuous care is superior compared to traditional oral hygiene instruction (OHI) to reduce patients' plaque score, bleeding on probing (BOP), and gingival index (GI) longitudinal. An additional goal is to investigate chairside time of implementing BMI.


Eligibility criteria: Inclusion Criteria:

* Male or Female
* ≥ 18 years old
* Periodontal maintenance phase (at least one year)
* Plaque score ≥30% (O'Leary plaque score)
* Minimum of two sites with BOP
* Willingness to fulfill all study requirements
* Patient of Record at the University of Minnesota School of Dentistry

Exclusion Criteria:

* Current smoker or quit smoking less than one year
* Pregnant, planning to become pregnant, or unsure of pregnancy status (self-reported)
* Uncontrolled diabetes (HbA1C \> 7)
* Medical conditions that may influence the outcome of the study (neurologic or psychiatric disorders, systemic infections, cancer, and/or HIV/AIDS)
* Current use of oral bisphosphonates
* History of IV bisphosphonates
* Require pre-medication or on long-term antibiotics
* Current orthodontic treatment or planning to begin orthodontic treatment during the study
* Unable to comply with the study protocol

Primary outcomes:
measure: Plaque score
timeFrame: Recorded four times over a one year time frame
measure: Bleeding on probing (BOP)
timeFrame: Recorded four times over a one year time frame
measure: Gingival Index
timeFrame: Recorded four times over a one year time frame
Secondary outcomes:
Other outcomes:
measure: Clinical attachment level
timeFrame: Recorded four times over a one year time frame
Locations:
city: Minneapolis
country: United States
facility: School of Dentistry
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Michelle Arnett, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02903758: Frequency and Distribution of Mixed Falciparum-vivax Infections in French Guiana
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
Collaborators: name: universite de guyane
First posted: 2016-09-16
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: malaria positive patients

Brief summary: Malaria is still endemic in the interior of French Guiana. mixed infections by 2 or more different malaria parasites lead to complex and potentially harmfull therapeutic problems. The aim of the study was to look at malaria smears between 2000 and 2008 and determine using PCR the frequency of mixed infections, and their distribution in the terrtory of French Guiana. Overall 10.75% of 400 smears showed mixed infection with P. falciparum and P. vivax. The Maroni river where Duffy negative populations live was largely devoid of vivax infections. These results suggest that mixed infections are frequent in french guiana except on the Maroni river which leads to practical implications for clinicians facing a patient with clinical malaria.


Eligibility criteria: Inclusion Criteria:

* malaria diagnosis

Exclusion Criteria:

* no malaria

Primary outcomes:
measure: malaria
timeFrame: At the time of diagnosis of malaria
Secondary outcomes:
Other outcomes:
Locations:
city: Cayenne
country: France
facility: Centre Hospitalier de Cayenne
state: French Guiana
Study officials:
References:
Clinical trial NCT00567658: Effect of Acid Suppression With Esomeprazole on Vocal Cord Granulomas
Official title: Effect of Aggressive Acid Suppression With Esomeprazole on Vocal Cord Granulomas: Randomized Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Larynx Disease
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2007-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to measure the effects of the drug, esomeprazole 40 mg (Nexium) or placebo (inactive drug) on vocal cord granulomas.

Detailed description: Vocal cord granulomas (VCG) are common structural lesions of vocal cords attributed to vocal abuse / misuse and recently to gastroesophageal reflux. Vocal process granulomas are reactive/reparative process, in which an intact or ulcerated squamous epithelium is underlaid by granulation tissue or fibrosis (4, 5). Ulualp et al (6) have reported a higher prevalence of pharyngeal acid reflux (PAR) events in patients with vocal cord lesions. In a case control study they showed that the prevalence of pharyngeal reflux, documented with 3 site pharyngoesophageal pH monitoring, is higher among patients with posterior laryngitis and vocal cord lesions than control (78% vs. 21%). Most recently our cohort trial in over 80 patients with laryngeal findings suggestive of GERD suggested that vocal cord abnormalities such as granulomas may be more specific sign of GERD than any other (7). Thus, there is reasonable scientific intrigue regarding this laryngeal finding and the causal role from gastroesophagopharyngeal acid reflux requiring better studies. However, no study has evaluated the potential causal association between GERD and VCGs.

Eligibility criteria: Inclusion Criteria:

Patients with vocal cord granulomas

Exclusion Criteria:

* Age \< 18
* Pregnancy
* Use of proton pump inhibitor (PPI) within the last 30 days

Primary outcomes:
measure: • Primary outcome: Vocal cord granuloma improvement +/- resolution Outcome categories-subjectively assessed at laryngoscopy (current practice)
timeFrame: 4 months
Secondary outcomes:
measure: Symptom improvement +/- resolution
timeFrame: 4 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Michael F Vaezi, MD, PhD, MS epi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00253058: Study Of Perennial Allergic Rhinitis In Pediatrics
Official title: Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Perennial Allergic Rhinitis-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Keywords: Allergic
pediatric
Rhinitis
Perennial
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-11-15
Enrollment: 286
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To verify of cetirizine dry syrup to ketotifen dry syrup in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment period


Eligibility criteria: Inclusion Criteria:

* Children with perennial allergic rhinitis.
* Giving informed consent.
* Children with a positive response to specific IgE antibody test.
* Children assessed as positive in the nasal eosinophil count.
* Children whose severity score of nasal symptom is 4 or higher.

Exclusion criteria:

* have spastic disease such as epilepsy
* have a history of drug hypersensitivity
* are pregnant, lactating or possibly pregnant female Children
* are sensitive to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods
* have vasomotor rhinitis and eosinophilic rhinitis
* have asthma that requires the treatment with corticosteroid
* have inappropriate complication of nasal disorder that may influence on the evaluation of the study drugs
* have complicated with atopic dermatitis or urticaria that requires the treatment with antihistamine preparation
* have started specific desensitization treatment or nonspecific modulation treatment but who have not reached the maintenance level of treatment
* have received surgical treatment for reduction and modulation of nasal mucosa
* redintegration therapy of nasal cavity to improve the degree of nasal airway
* surgical operation to improve rhinorrhea.

Primary outcomes:
measure: change in the total nasal symptom score (TNSS)
Secondary outcomes:
measure: - Individual daily nasal symptom score - Investigator global improvement/patient global improvement - Nasal findings - Cetirizine serum concentrations - Adverse events
Other outcomes:
Locations:
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01438658: Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma
Official title: Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uveal Melanoma
Keywords: uveal melanoma
metastatic uveal melanoma
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-09-22
Enrollment: 250
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 diagnosed with uveal melanoma being treated at our center

Brief summary: Uveal melanoma is the most common primary intraocular tumor in adults. The local treatment is effective, but patients still die of metastatic disease. It has been shown that early diagnosis of a few isolated metastases can result in a clean surgical excision of the metastases and an extension of the expected survival from 7-12 months to over 10 years on some patients.

Many serum biomarkers are employed in Oncology. It makes sense to try the relevant ones in the diagnosis of metastatic uveal melanoma.

The investigators hypothesis is that a soluble serum biomarker level changes upon development of metastatic disease either by secretion by the tumor cells themselves or by their environment. Detection of changes in biomarker level may lead to the diagnosis of metastases before they can be detected by imaging modalities, thus allowing for early treatment of the metastases and a better chance of success.


Eligibility criteria: Inclusion Criteria:

* diagnosis of uveal melanoma

Exclusion Criteria:

* refusal to participate in the study

Primary outcomes:
measure: Significant increase in biomarker level that could be linked with detection of metastases by imaging
timeFrame: up to 12 months before diagnosis of metastases
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Specialized Ocular Oncology Service, Hadassah-Hebrew-University Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Shahar Frenkel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frenkel S, Nir I, Hendler K, Lotem M, Eid A, Jurim O, Pe'er J. Long-term survival of uveal melanoma patients after surgery for liver metastases. Br J Ophthalmol. 2009 Aug;93(8):1042-6. doi: 10.1136/bjo.2008.153684. Epub 2009 May 7.
citation: Mariani P, Piperno-Neumann S, Servois V, Berry MG, Dorval T, Plancher C, Couturier J, Levy-Gabriel C, Lumbroso-Le Rouic L, Desjardins L, Salmon RJ. Surgical management of liver metastases from uveal melanoma: 16 years' experience at the Institut Curie. Eur J Surg Oncol. 2009 Nov;35(11):1192-7. doi: 10.1016/j.ejso.2009.02.016. Epub 2009 Mar 28.
citation: Haritoglou I, Wolf A, Maier T, Haritoglou C, Hein R, Schaller UC. Osteopontin and 'melanoma inhibitory activity': comparison of two serological tumor markers in metastatic uveal melanoma patients. Ophthalmologica. 2009;223(4):239-43. doi: 10.1159/000206139. Epub 2009 Mar 6.
Clinical trial NCT01321658: Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer
Official title: Geriatric Intervention in Elderly Surgical Patients With Colorectal Cancer - a Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: Geriatric Assessment
Perioperative Care
Colorectal Neoplasms
Frail Elderly
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Cancer Society
name: University Hospital, Akershus
First posted: 2011-03-23
Enrollment: 122
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled trial on frail elderly patients (aged 65+) with colorectal cancer. The patients will be randomized into two groups. The control group will receive standard surgical treatment. The intervention group will in addition go through a preoperative comprehensive geriatric assessment. The assessment will include evaluation of co-morbidity and medication, social status, nutritional status, cognition, depression and physical performance. This assessment will form basis of an individualized perioperative intervention.

The main aim of the study is to see if the number of postoperative complications in this group can be reduced by a perioperative geriatric intervention. A study of inflammation markers in serum will also be performed, with focus on identifying potential biological frailty markers.


Eligibility criteria: Inclusion Criteria:

* Age 65+
* Elective surgery for colorectal cancer
* Frail

Exclusion Criteria:

* Acute surgery
* Not able to consent
* Does not consent with registration

Primary outcomes:
measure: Postoperative complications
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Reoperation
timeFrame: 30 days after surgery
measure: Readmission
timeFrame: 30 days after surgery
measure: Length of hospital stay
timeFrame: 30 days after surgery
measure: Survival
timeFrame: 3 months after surgery
measure: Quality of life
timeFrame: 3 months after surgery
measure: Living at home or in institution
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dept of gastrointestinal surgery, Oslo University Hospital
Study officials:
affiliation: Geriatric dept., Oslo University hospital
name: Torgeir B Wyller, Dr.med
role: STUDY_CHAIR
References:
Clinical trial NCT01421758: Testing the Efficacy of an Online Social Network Intervention to Increase Social Support for Physical Activity
Official title: Using Facebook to Increase Social Support for Physical Activity: The INSHAPE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Cancer
Obesity
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2011-08-23
Enrollment: 134
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was designed to determine whether participation in an online social network intervention increases perceived social support for physical activity versus a minimal education control group by conducting a randomized controlled trial with 140 female undergraduate students. The investigators hypothesize that participants in the physical activity centered online social network intervention group will have greater increases in perceived social support for physical activity compared to minimal web based physical activity education controls.


Eligibility criteria: Inclusion Criteria:

* female
* under the age of 25
* currently enrolled full time or part time student at the University of North Carolina at Chapel Hill
* classified as an undergraduate
* answers no to all questions on an exercise risk factor questionnaire (PAR-Q) or is cleared in writing by a physician to participate in an independent exercise program
* a score of less than 3 on the SCOFF eating disorders questionnaire
* less than 30 minutes per day of self reported moderate or vigorous physical activity
* regular Facebook use as defined by self reported owning of an account and use of at least 30 minutes per day
* willing to provide informed consent
* willing to participate in the intervention
* literate in the English language.

Primary outcomes:
measure: Mean perceived social support for physical activity scores on the Peer/Friend Support for Healthy Eating and Physical Activity Scale.
timeFrame: 10 weeks
Secondary outcomes:
measure: Physical activity in kilocalories on the Paffenbarger Physical Activity Questionnaire/College Alumnus Questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: David N Cavallo, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cavallo DN, Tate DF, Ries AV, Brown JD, DeVellis RF, Ammerman AS. A social media-based physical activity intervention: a randomized controlled trial. Am J Prev Med. 2012 Nov;43(5):527-32. doi: 10.1016/j.amepre.2012.07.019.
Clinical trial NCT03517358: Virological Suppression in HIV Positive Patients Involved in a Novel Standardized Adherence Protocol
Official title: Virological Suppression in HIV Positive Patients Involved in a Novel, Standardized Adherence Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hiv
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will look at virologically suppression of patients with HIV who receive pharmacist or case management care.


Eligibility criteria: Inclusion Criteria:

* Patients with a baseline viral load \> 200 copies/ml
* Patients who agree to program enrollment
* Patients ≥ 18 years of age

Exclusion Criteria:

* Pregnant women
* Adults unable to consent
* Prisoners

Primary outcomes:
measure: Percentage of virological suppression
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: One Community Health
state: California
Study officials:
References:
Clinical trial NCT00414258: The Holding Study: Feeding Analgesia in Preterm Infants
Official title: The Holding Pilot Study: Feeding Analgesia in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain Response
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2006-12-21
Enrollment: 15
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of mothers' skin-to-skin holding during feeding via a soother trainer with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure

Hypothesis:

1. When held by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.
2. Following holding during the blood collection, mothers will find no differences in their infants' feeding ability.

Detailed description: Research Method:

In a between subjects, randomized design, 20 stable preterm infants born between 30-35 weeks gestational age will be studied. Infants will be randomized to one of two interventions which will take place during blood collections that are required for clinical management. For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection. For the holding condition, infants will be held skin-to-skin by their mothers and given breast milk using a soother trainer during the blood collection.

Eligibility criteria: Inclusion Criteria:

* Born between 30-35 weeks gestational age
* Mother has fluent English

Exclusion Criteria:

* CNS injury
* congenital anomaly
* active infection
* has had no surgeries or analgesics/sedatives in last 72 hours
* history of maternal drug exposure

Primary outcomes:
measure: Videotaped and recorded at Baseline, Lance and Recovery:Neonatal Facial Coding System - total facial score; Heart Rate
Secondary outcomes:
measure: Videotaped and Recorded at Baseline, Lance and Recovery:Hand Movements; Sleep/Wake States
measure: Samples taken at baseline and recovery;Salivary Cortisol sample
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Children's and Women's Health Centre of British Columbia, Special Care Nursery
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Liisa Holsti, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: