louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05698290: HELP Pain Training Program
Official title: Engaging School Providers to Manage Student Pain in Michigan Schools
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pain
Keywords: Pain
Cognitive Behavioral Therapy
School Providers
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Providers (nurses and mental health professionals) serving Michigan schools.

Brief summary: The aim of this project is to develop and test the Helping Educators Learn Pediatric Pain Assessment \& Intervention Needs (HELP Pain) program. HELP Pain provides training for school providers (e.g., school nurses, mental health professionals) on strategies to assess and manage pain-related concerns in school children. Participants will learn cognitive behavioral therapy techniques to help school children manage pain, and report on their use of strategies, and child's progress throughout the school year. Follow-up data will be collected in year 2.

Detailed description: Chronic pain is common among school children, and impacts social, emotional and academic functioning. School providers are often tasked with addressing student pain, but may have limited training in evidence-based pain management strategies. Thus, the PI developed a training program, HELP Pain, to train school providers, such as school nurses and mental health professionals, in cognitive behavioral therapy strategies for addressing student pain. In this study, the feasibility and acceptability of the training program will be evaluated. Provider knowledge will be evaluated before and after receiving the HELP Pain training. Further, the use of HELP Pain strategies with students and their associated disability and pain outcomes will be evaluated. Results will help to tailor the HELP Pain training program for future use.

Eligibility criteria: Inclusion Criteria:

* engaged as a school provider in Michigan

Primary outcomes:
measure: Feasibility - Qualitative report
timeFrame: 9 months
measure: Acceptability - Qualitative report
timeFrame: 9 months
measure: Appropriateness - Qualitative report
timeFrame: 9 months
measure: Implementation Success - Quantitative report
timeFrame: 9 months
Secondary outcomes:
measure: Knowledge
timeFrame: 9 months
measure: Fidelity
timeFrame: 9 months, 2 years
measure: Self-report Knowledge
timeFrame: 9 months
Other outcomes:
measure: Child Functional Disability Inventory (FDI)
timeFrame: 9 months, 2 years
measure: Child Pain Ratings - Numerical Scale
timeFrame: 9 months, 2 years
measure: Child Pain Ratings - Faces Scale
timeFrame: 9 months, 2 years
measure: Child School Attendance
timeFrame: 9 months, 2 years
Locations:
city: Grand Rapids
country: United States
facility: Michigan State University
state: Michigan
Study officials:
affiliation: Michigan State University
name: Natoshia R Cunningham, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00924690: Colon Cancer Prevention Study
Official title: Disparities in Colorectal Cancer Prevention Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colon
Cancer
Screening
Prevention
Information
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2009-06-19
Enrollment: 207
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
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 design messages which can help people learn more about how to prevent colon cancer. Eligible participants will be asked to review a series of short cancer prevention messages and share their opinions on them. Participants also need to fill out a short survey with questions on their background and attitudes and knowledge about physical activity and colon cancer. The whole study can be completed online and will take less than 1 hour. After completing the entire study, participants will receive $25.

If you are interested in participating in this study, please visit the following website:

https://surveys.chaicore.com/preventcancer/

Detailed description: The goal of this research is to develop and test potential intervention messages which can be used to help increase colon cancer prevention behaviors. Two sets of intervention messages will be developed: generic and behavioral. Using a randomized control design the investigators will evaluate the behavioral messages among women. This message testing protocol will help them determine if the messages are relevant, acceptable, comprehensible, memorable, and motivating for the target audience. The investigators' hypothesis is that the behavioral messages will receive more positive ratings than the generic messages. If so, they will be used to promote cancer screening and physical activity in future intervention studies.

Eligibility criteria: Inclusion Criteria:

* Female
* Ages 50-80 years old

Primary outcomes:
measure: Elaboration using the Elaboration Likelihood Scale
timeFrame: This study is to be completed in one session. The outcome is measured immediately after reading messages
Secondary outcomes:
measure: Behavioral Intention to Engage in Colorectal Cancer Screening or Physical Activity
timeFrame: This study is to be completed in one session. The outcome is measured immediately after reading messages
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC
name: Lucia A Leone, BA
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC
name: Marci K Campbell, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02918903: Evaluation of Pulp Symptoms After Minimal Caries Removal in Treatment of Deep Caries
Official title: Evaluation of Pulpal Symptoms Following Minimal Caries Removal Technique in Comparison to Complete Caries Removal in Molars With Deep Caries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 70
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess and compare the possible post-operative pulpal symptoms (Spontaneous pain, pain on percussion, swelling, sinus or fistula), incidence of pulp exposure, child acceptance, chair time and radiographic success between two techniques for managing dental caries: minimal caries removal and complete caries removal in primary molars.

Detailed description: Minimal Caries Removal (MCR) technique was described in 2015 by Chompu-inwai et al., as a treatment option for primary molars with deep carious lesions or reversible pulpitis where only soft demineralized dentin around the lateral walls of the carious lesion is removed. The aim of this study is to assess the success of such a technique in managing primary molars with asymptomatic deep caries in terms of; post-operative pulpal symptoms(spontaneous pain, pain on percussion, fistula or sinus), incidence of pulp exposure, child acceptance, chair time and radiographic success.

Eligibility criteria: Inclusion Criteria:

* Primary molar with deep dentin caries involving occlusal \&/or occluso-proximal surfaces.
* Absence of clinical signs and symptoms of irreversible pulpitis such as spontaneous pain. Only presence of pain provoked with stimulation, such as complaints of food impaction when eating is allowed.
* Absence of clinical swelling or pus exudates/fistula of soft or periodontal tissues.
* Absence of abnormal tooth mobility.
* Absence of pain on percussion.
* Restorable tooth.

Radiographic inclusion criteria:

* Extension of dental caries one-third or more of the entire dentin thickness.
* No super- imposition of dental caries on the dental pulp.
* No widened periodontal ligament (PDL) space.
* No radiolucency in the peri-apical or furcation areas.
* No pathologic internal or external root resorption.
* No pulp canal calcification or obliteration.

Exclusion Criteria:

1. Patients experience any signs or symptoms of pulpal or peri-apical pathology.
2. Patients with systemic diseases requiring special dental consideration.
3. Unmotivated, uncooperative patients.
4. Patients unable to attend follow-up visits.

Primary outcomes:
measure: Post operative pain assessed by direct questioning as binary outcome
timeFrame: 9 months
Secondary outcomes:
measure: incidence of pulp exposure
timeFrame: Within 30 minutes
measure: radio-graphic success
timeFrame: 9 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of denntistry
state: El-manyal
Study officials:
References:
Clinical trial NCT05742503: Progesterone Containing Contraceptive Methods on Endogenous Progesterone Level
Official title: Effects of Different Progesterone Containing Contraceptive Methods on Safety and Endogenous Progesterone Level
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Progesterone
Contraceptive Methods
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Among patients attending Tanta University Hospitals

Brief summary: The aim of this study is to assess the effect of different progesterone containing contraceptive methods on safety and endogenous progesterone level

Detailed description: Progestogen-only' contraceptives are presented as injections, implants, oral formulations, hormone-releasing intrauterine methods and emergency contraceptives. These substances could be used by females who are breastfeeding or have other contraindications to estrogen treatment, including those who are immediately postpartum, have thalassemia, sickle-cell disease, gallbladder disease, or currently experiencing thrombo-embolic disorders, valvular heart disease, ischemic heart disease.

Intrauterine, injectable methods and contraceptive implants named as long-acting reversible contraceptives (LARC) are the more efficient reversible contraceptive approaches are highly effective, longer-acting contraceptive methods levels.

Eligibility criteria: Inclusion Criteria:

* 80 healthy fertile females
* 20-35 years
* With normal menstrual history
* Had at least one offspring after spontaneous pregnancy

Exclusion Criteria:

* Any disease affects uterus (uterine tumors fibroids, endometriosis, prolapse, or tuberculosis).
* Ovarian tumors
* submucous myoma
* irregular menstrual cycle
* past or family history of breast disease
* Diabetic patients,
* medication affecting reproductive or metabolic functions.
* endometrial thickness \<7 mm on the secretory transformation day
* history of spontaneous abortions
* history of embryo transfer failure on over three occasions
* Patients had cortisol medications
* patients who received radiological treatment

Primary outcomes:
measure: Assess the effect of different progesterone containing contraceptive methods on safety and endogenous progesterone level
timeFrame: Six mounths
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Ahmed Ossman
state: El-Gharbia
Study officials:
affiliation: Assistant Professor of Obstetrics and Gynecology Department, Faculty of Medicine,Tanta University
name: Mona K Omar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05723003: Prospective Validation of an Acute Pulmonary Embolism Severity and Prognosis Prediction Model
Official title: Multicenter Prospective Validation and Extension of the 'PUMCH' Acute Pulmonary Embolism Severity and Prognosis Prediction Model
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Embolism
Keywords: Pulmonary Embolism
Prognosis assessment model
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients with acute PTE diagnosed by imaging (CTPA, enhanced CT, V/Q imaging suggesting a high probability of PE, pulmonary angiography, MRPA).

Brief summary: The purpose of this study is to prospectively validate the first PUMCH model for acute PE severity and prognosis prediction based on multi-center data constructed in the pre-project period based on national population data, and to optimize the PUMCH model based on artificial intelligence clustering algorithm.

Detailed description: Patients with pulmonary embolism and aged 18 years or older were enrolled in this study.Patient demographic characteristics(age, sex, department, diagnosis), basic vital signs, symptoms at their admissions (hemoptysis, dyspnea, chest pain, syncope, laboratory examinations (blood lab routines, blood gas, liver and kidney function, myocardial marker), and imaging examinations (vascular ultrasonography, computed tomographic angiography, echocardiography, chest CT,CTPA, pulmonary perfusion imaging, pulmonary angiography, PET/CT) were prospectively collected. Patients were followed up every 1/3/6 months to obtain survival outcomes.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* Inpatients with acute PTE diagnosed by imaging (CTPA, enhanced CT, V/Q imaging suggesting a high probability of PE, pulmonary angiography, MRPA) containing any of the following conditions.

  1. primary acute PTE combined with or without DVT
  2. recurrent acute PTE with a history of previous PTE or DVT
* signed informed consent form

Exclusion Criteria:

* blinded to any diagnostic or therapeutic test (VTE or other conditions)
* unable to complete follow-up (due to cognitive or behavioral limitations, etc.)

Primary outcomes:
measure: All-cause mortality
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Juhong Shi, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00056303: Mental Health Services for Foster and Adopted Children
Official title: Specialized Mental Health Services for Foster Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Problem Behaviors
Attention Deficit Hyperactivity Disorder
Depression
Keywords: Attachment
Intervention
Prevention
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-03-11
Enrollment: 220
Sex: ALL
Minimum age (years): 20
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will determine the effectiveness of a relationship-based intervention in improving the interaction between caregivers and young children placed in their care.

Detailed description: Infants and toddlers who are placed into foster or adoptive care often exhibit a number of behavioral, emotional, and physiological problems. In the absence of specialized services, problems in the relationship between caregiver and child may develop; problems in the child's functioning often persist and are exacerbated. This study will attempt to alleviate the attachment and regulatory difficulties that affect many young children placed into care.

Children are randomly assigned to either an experimental group or to a treatment control group for 3 years. The experimental group focuses on relational issues; the control group focuses on cognitive development. Caregivers receiving the relational intervention are trained to provide nurturing care, and to help children learn to develop adequate regulatory skills. Caregivers in the treatment control group receive training designed to enhance children's cognitive development. Caregivers in both groups will receive 10 home visits. Observations of children and parents are used to assess participants.

Eligibility criteria: Inclusion Criteria:

* Toddler placed into foster care
* Resident of Delaware and surrounding counties in Pennsylvania and Maryland

Exclusion Criteria:

* Significant medical problems

Primary outcomes:
measure: Attachment
timeFrame: Annually
Secondary outcomes:
measure: Executive Functioning
timeFrame: Annually
measure: Diurnal production of cortisol
timeFrame: Annually
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Mary Dozier, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00491803: Sildenafil Effects on Pulmonary Haemodynamics and Gas Exchange in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Acute Effects of a Single Dose of Sildenafil (20mg/40mg) on Pulmonary Haemodynamics and Gas Exchange at Rest and During Exercise in COPD Patients With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Pulmonary Hypertension
Keywords: COPD
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2007-06-26
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD), we hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition. However, in COPD sildenafil may also impair gas exchange due to the inhibition of pulmonary hypoxic vasoconstriction. The research project is aimed to evaluate these effects.

It is a prospective, randomized, double-blind study to evaluate the acute effects of a single dose of 20 or 40 mg of sildenafil on gas exchange and pulmonary hemodynamics. Subjects: 20 patients (10 in each group). Measurements: pulmonary hemodynamics, arterial blood gasses and ventilation-perfusion distributions; at rest and during sub-maximal exercise.


Eligibility criteria: Inclusion Criteria:

* COPD (FEV1/FVC\<0.7)
* Age 40-75
* Pulmonary hypertension (Vmax TI\>=2.8m/sec)

Exclusion Criteria:

* Treatment with CYP3A4 inhibitors, nitrates, PDE-5 inhibitors
* Coronary disease
* Ischemic optical neuritis

Primary outcomes:
measure: Reduction of mean PAP and PVR
timeFrame: 60 minutes
Secondary outcomes:
measure: CO, PaO2, V/Q
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital clinic
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Joan albert Barbera, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blanco I, Gimeno E, Munoz PA, Pizarro S, Gistau C, Rodriguez-Roisin R, Roca J, Barbera JA. Hemodynamic and gas exchange effects of sildenafil in patients with chronic obstructive pulmonary disease and pulmonary hypertension. Am J Respir Crit Care Med. 2010 Feb 1;181(3):270-8. doi: 10.1164/rccm.200907-0988OC. Epub 2009 Oct 29.
Clinical trial NCT00082303: Music Imagery for Patients Receiving Chemotherapy for Leukemia or Non-Hodgkin's Lymphoma
Official title: Music Imagery for Patients in Protected Environments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leukemia
Lymphoma, Non-Hodgkin
Keywords: Music Therapy
Anxiety
Depression
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the effect of music imagery on patients receiving intensive chemotherapy for acute leukemia or high-grade non-Hodgkin's lymphoma.

Detailed description: Standard treatment for acute leukemia and high-grade non-Hodgkin's lymphoma includes intensive chemotherapy that typically requires a 4-week hospital stay in protective isolation. Patients treated in isolation units may experience elevated levels of psychological distress. Both guided imagery and music therapy have been effective in improving the moods of cancer patients, but studies have not been conducted in acute leukemia and non-Hodgkin's lymphoma patients. This study will evaluate the effect of music imagery on these patients.

Participants in this study will be randomly assigned to receive either standard care plus music imagery or standard care alone. Participants assigned to the standard care plus music imagery group will receive a 45-minute weekly music imagery session with a music therapist. All participants will complete questionnaires and self-reports regarding their general anxiety, affect, and fatigue.

Eligibility criteria: Inclusion Criteria:

* Admitted to Indiana University Hematologic Malignancy Program for the treatment of newly diagnosed or recurrent acute leukemia or high-grade non-Hodgkin's lymphoma
* Able to read and understand English

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Cancer Center/University Hospital
state: Indiana
Study officials:
References: