louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06366282: Pediatric and Caregiver Traumatic Stress Intervention (PACTS)
Official title: Pediatric and Caregiver Traumatic Stress Intervention: A Path Forward After Injury for Pediatric Survivors and Their Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Injury
Keywords: posttraumatic stress disorder
depression
pediatric injury
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Childress Institute for Pediatric Trauma
First posted: 2024-04-15
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to learn more about how to help the caregiver and child survivor of a traumatic injury handle post-traumatic stress disorder and/or depression.

Detailed description: This study is a trial to determine if a caregiver-child dyadic screening and caregiver intervention with pediatric trauma patients reduces traumatic stress symptoms in both child and caregiver, and depressive symptoms in caregivers compared to the current standard of care. The purpose of the PACTS Intervention is to identify and address the needs of the caregiver and the child survivor who are at-risk for developing post-traumatic stress disorder and/or depression following traumatic injury of the child.

Eligibility criteria: Inclusion Criteria:

* Child requires inpatient treatment for an unintentional injury (e.g. burns, dog bite, road traffic accident) in the pediatric trauma and/or pediatric burns units
* English-speaking adults, with English denoted as the primary language in the electronic medical record (EMR)
* Caregiver-child dyads who screen positive with the Peritraumatic Distress Inventory (PDI) Tools will be invited to participate in the randomized controlled trial.

Exclusion Criteria:

* Patients and/or caregivers with cognitive deficits, with psychotic symptoms, refusing treatment, and leaving the hospital against medical advice (AMA) were unable to participate in counseling interventions by condition or by choice and are excluded from the study population

Primary outcomes:
measure: Change in Kessler 6 Scores
timeFrame: From baseline to Month 3
measure: Change in Patient Health Questionnaire - 9 (PHQ-9) Scores
timeFrame: From baseline to Month 3
measure: Change in Child and Adolescent Trauma Screen (CATS) Scores
timeFrame: From baseline to Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Elizabeth Shilling, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02529982: Curcumin Supplementation and Patients With Type 2 Diabetes
Official title: The Effect of Curcumin Supplementation on Anthropometric Indices, Insulin Resistance and Oxidative Stress in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Insulin Dependent Diabetes
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetes mellitus is the most common endocrine disorder, causes many complications such as micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed, but most of them have side effects. Recently, the use of natural plant products has gained more attention among scientists in order to prevent diabetic vascular complications. Curcumin is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory, anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in reducing glycemic index and hyperlipidemia in rodent models and is relatively inexpensive and safe. Most of the studies conducted on animal model, and just a few of them are on human model. The present study was planned to evaluate the effects of curcumin supplementation The effect of curcumin supplementation on anthropometric indices, insulin resistance and oxidative stress in patients with type 2 diabetes


Eligibility criteria: insulin Inclusion Criteria:

* a) Tendency to participate b) Age range of 40-65 c) Suffering from diabetes type 2 ( between 1 to 10 yeares) d) BMI 18/5-30 e) Patients with diabetes who administer oral hypoglycemic agents and do not use

Exclusion Criteria:

* a) patients with liver diseases b) patients with kidney diseases c) patients with inflammatory diseases d) patients with liver diseases e) Administering herbal agents f) Administering multivitamins and minerals in past 3 months

Primary outcomes:
measure: fasting blood sugar
timeFrame: 10 weeks
measure: Insulin
timeFrame: 10 week
measure: HbA1c
timeFrame: 10 week
measure: Homeostatic Model Assessment of Insulin Resistance
timeFrame: 10 week
measure: Change in pancreatic B-cell function
timeFrame: 10 week
Secondary outcomes:
measure: total capacity antioxidant
timeFrame: 10 weeks
measure: Malondialdehyde
timeFrame: 10 week
measure: Body mass index
timeFrame: 10 week
measure: Waist circumference
timeFrame: 10 week
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: NNFTRI clinic
Study officials:
References:
Clinical trial NCT02739620: Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors
Official title: Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 22
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Exercise training has beneficial effects in cancer survivors to minimize some of the side effects of cancer and its treatment and improve long-term prognosis, but there are numerous hurdles for individuals diagnosed with, and being treated for, cancer to participate in exercise programs. The goal of this research study is to begin to evaluate whether exercise training via neuromuscular electrical stimulation (NMES) has beneficial effects on skeletal muscle size and function in cancer survivors.


Eligibility criteria: Inclusion Criteria:

1. stage I, II or III breast cancer
2. receiving neoadjuvant or adjuvant chemotherapy with or without radiation
3. a body mass index \<35 kg/m2.

Exclusion Criteria:

1. metastatic disease, a prior history of cancer, excluding non-melanoma skin cancer, or prior receipt of chemotherapy
2. autoimmune, vascular or neuromuscular disease that could alter skeletal muscle
3. prior knee or hip replacement
4. contraindications for use of neuromuscular electrical stimulation, including an implanted cardiac defibrillator or pacemaker, lower extremity blood clot or coagulopathy
5. pregnancy

Primary outcomes:
measure: Maximal Calcium-activated Tension Single Muscle Fiber Tension
timeFrame: Difference between values at baseline at 2 months
measure: Cross-sectional Area of Skeletal Muscle Fibers
timeFrame: Difference between values at baseline at 2 months
measure: Intermyofibrillar Mitochondrial Content
timeFrame: Difference between values at baseline at 2 months
Secondary outcomes:
measure: Single Muscle Fiber Contractile Velocity
timeFrame: Difference between values at baseline at 2 months
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont College of Medicine
state: Vermont
Study officials:
affiliation: University of Vermont
name: Michael J Toth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06223620: A Multicenter Retrospective Review of Management Strategies in Small Bowel Obstruction
Official title: A Multicenter Retrospective Review of Management Strategies in Small Bowel Obstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SBO - Small Bowel Obstruction
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previous studies found on an average 3.9 to 9.4% patient suffer from SBO. The disease incidence varies depending on the cause of obstruction. Assuming that 3.9% of the patients will be affected by SBO, the study would require a sample size of 504 for estimating the expected proportion with 3% absolute precision and 95% confidence.

Brief summary: The objective of the study is to review performance of water soluble contrast study in patients admitted with Small Bowel Obstruction(SBO), will improve quality and safety, and decrease length of stay and morbidity.

Detailed description: Performance of contrast study has been a part of the protocols at multiple institutions of the southwestern surgical congress. Plan to perform a retrospective review of management protocols at these institutions. Wish to know whether the implementation of a standardized, protocol-driven pattern of practice involving the performance of water soluble contrast study in patients admitted with SBO, will improve quality and safety, and decrease length of stay and morbidity.

The objective of the study is to review performance of water soluble contrast study in patients admitted with SBO, will improve quality and safety, and decrease length of stay and morbidity.

Performance of contrast study has been a part of the protocols at multiple institutions of the southwestern surgical congress.

Hypothesize that implementation of a standardized, protocol-driven pattern of practice involving the performance of water soluble contrast study in patients admitted with SBO, will improve quality and safety, and decrease length of stay and morbidity.

Eligibility criteria: Inclusion Criteria:

* • Adults aged 18-89 years of age

  * Patients presenting with SBO

Exclusion Criteria:

* • Prisoners

  * Pregnant women

Primary outcomes:
measure: Morbidity and length of stay
timeFrame: 1 year
Secondary outcomes:
measure: Patient demographics
timeFrame: 1 year
measure: admit date
timeFrame: 1 year
measure: discharge date
timeFrame: 1 year
measure: admission service
timeFrame: 1 year
measure: Aspirin(ASA )class
timeFrame: 1 year
measure: comorbidities
timeFrame: 1 year
measure: surgical history
timeFrame: 1 year
measure: labs
timeFrame: 1 year
measure: time of contrast given
timeFrame: 1 year
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Michael Truitt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00611520: Symbicort in Chronic Obstructive Pulmonary Disease
Official title: Symbicort in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: treatment of COPD
related to the budesonide/formoterole therapy in patients with COPD.
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-11
Enrollment: 64730
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: patients

Brief summary: Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e. pneumologists and internists) are asked to document relevant data related to the budesonide/formoterole therapy in patients with COPD.


Eligibility criteria: Inclusion Criteria:

* Patients with COPD treated with budesonide/formoterol

Exclusion Criteria:

* limitations; possible risks; warnings; contraindications mentioned in the SPC.

Primary outcomes:
Secondary outcomes:
measure: to get further insight into the details of the use , dosage scheme and duration of treatment with budesonide /formoterol in this population
Other outcomes:
Locations:
Study officials:
affiliation: Medical Department AstraZeneca Germany
name: Kai Richter, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01620320: Stress Echocardiography Versus Coronary Angiography for Left Main Stenosis Detection
Official title: Évaluation de l'Echographie de Stress Par Comparaison à la Coronarographie Comme Outil Non Invasif de détection de la resténose Intra endoprothèse du Tronc Commun
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Left Main Coronary Artery Disease
Stenosis
Keywords: Left main coronary artery
Coronary artery disease
Stress echography
Intrastent stenosis
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 0
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: Patients presenting to teaching hospital or stent from community hospitals to teaching hospital and having left main angioplasty

Brief summary: Left main stenosis use to be treated by bypass but with the improvement of angioplasty techniques, an increasing number of patients are submit to left main coronary angioplasty. Consequences of left main intra stent stenosis can be disastrous yet, for the moment, no precise recommendation concerning the follow up of these patients exist. The investigators ought to determine if stress echocardiography can predict left main intra stent stenosis as well (non inferiorly)as control angiography that use to be done.

Detailed description: All patients of the study will pass coronary angiogram and stress echocardiography (treadmill of dobutamine).

Eligibility criteria: Inclusion Criteria:

* patients over 18 years old able to give consent and having had left main angioplasty.

Exclusion Criteria:

* Bypass on the left anterior descending coronary artery or left circumflex (" protected left main ")
* Treating physician judge that angiography need to be done straightaway
* Follow up elsewhere than the CHUS
* Patient refusal
* Pregnant women
* Stress echo contraindication(Severe high blood pressure or malignant arrhythmia)or condition that limits interpretation (Left bundle branch block or pacemaker rhythm)

Primary outcomes:
measure: Correlation between stress echocardiography results for the detection of left main prosthesis stenosis with coronary angiogram results.
timeFrame: 9 to 12 months after left main angioplasty
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Paul Farand, Cardiologue
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02556320: Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs
Official title: Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Drug Hypersensitivity Syndrome
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A recent study has shown that certain drug allergies were actually related to an immune system against certain viruses. The aim of the study is to evaluate, in patients taking antiepileptic drugs, if this treatment induces proliferation of these viruses and secondarily an immune response that would promote the development of a rash. In particular, will be studied whether these drugs can induce virus reactivation "dormant" in the immune system. This study will not affect the usual follow-up proposed by investigators, with the exception of some additional blood samples.


Eligibility criteria: Inclusion Criteria:

* Patients age over 18 years
* Patient for whom treatment of antiepileptic class will be started or was set for less than 48 hours and including one of the following molecules (as princeps or generic equivalent form): sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine eslicarbazepine acetate.
* Patient or patient's representative who was informed and signed the consent form
* Effective contraception in women of childbearing age
* Affiliation to health insurance

Exclusion Criteria:

* Immunosuppressive therapy in progress or acquired immunodeficiency
* Patient with meningitis or meningoencephalitis
* Patient with known contraindications to any molecules indicated in the study
* Major Patient protection (guardianship) or deprived of liberty by judicial or administrative decision.
* Patient participating in another clinical trial or participated in another trial in the month before.
* Pregnant or breastfeeding women.

Primary outcomes:
measure: Number of patients with viral reactivation of Epstein-Barr Virus
timeFrame: 3 Months
measure: Number of patients with viral reactivation of Human Herpes Virus 6
timeFrame: 3 Months
measure: Number of patients with viral reactivation of Human Herpes Virus 7
timeFrame: 3 Months
Secondary outcomes:
measure: Change from baseline in lymphocyte population count
timeFrame: 3 Months
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Sophie DUVERT-LEHEMBRE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04165720: Physical Activity Recommendation Behaviour in German Psychiatrists
Official title: Physical Activity Recommendation Behaviour in German Psychiatrists
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Mental Disorder
Physical Activity
Keywords: Physical Activity
Mental Disorder
Recommendation Behaviour
Mental Health
Exercise
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Psychiatrists (already specialized in psychiatry or currently in specialization in psychiatry) that currently work with patients with mental disorders in Germany.

Brief summary: The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German psychiatrists working with patients with mental disorders.

Detailed description: Physical activity plays an important role in the prevention and treatment of mental disorders. Despite the potential mental health benefits, large proportions of patients with mental disorders do not meet the physical activity recommendations.

Psychiatrists play a key role in the recommendation of physical activity to their patients. There are no previous studies that examine physical activity recommendation behaviour in German psychiatrists.

The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German psychiatrists working with patients with mental disorders.

Eligibility criteria: Inclusion Criteria:

* Physician specialized in psychiatry or currently in training for specialization in psychiatry
* Currently working with patients with mental disorders
* At least 18 years old
* Sufficient German skills for answering the questionnaire

Exclusion Criteria:

None

Primary outcomes:
measure: Exercise in Mental Illness Questionnaire (EMIQ) - German Version
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin - Department for Psychiatry and Psychotherapy - Charité Campus Mitte
Study officials:
affiliation: Charité Universitätsmedizin Berlin- Charité Campus Mitte - Department for Psychiatry and Psychotherapy
name: Moritz B Petzold, Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01641120: Assessing Tolerability of Avonex Intramuscular Injections
Official title: Assessing Tolerability of Avonex Intramuscular Injections With a 25 Gauge Needle Versus 30 Gauge Needle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Intramuscular Injections
Relapsing Remitting
Lead sponsor: Trinity Health Of New England
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2012-07-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly.


Eligibility criteria: Inclusion Criteria:

* Between 18 - 65 years of age;
* Confirmed diagnosis of Relapsing Remitting Multiple Sclerosis;
* Currently being treated with Avonex® for at least 90 days;
* Using 25 gauge needles for injection of Avonex® for at least 90 days;
* Willing and able to complete study questionnaires; and
* Provided informed consent to participate in this study

Exclusion Criteria:

* Diagnosis of Progressive Multiple Sclerosis;
* History of recent illness or infection;
* History of allergic reaction to Avonex®;
* Any prior usage of a 30 gauge needle for administration of Avonex®;
* Concurrent treatment with other immunomodulating therapies;
* Pregnant or planning on becoming pregnant;
* Nursing mothers; and
* Unable to complete the requirements of the study

Primary outcomes:
measure: Change in Patient Visual Analog Scale Score for Pre-injection Anxiety
timeFrame: Weeks 2, 3, 4, 5
measure: Visual Analog Scale Score for Post-injection Pain
timeFrame: Weeks 2, 3, 4, 5
Secondary outcomes:
measure: Fear of Injection
timeFrame: Weeks 2, 3, 4, 5
measure: Perception of Needle
timeFrame: Weeks 2, 3, 4, 5
Other outcomes:
Locations:
city: Hartford
country: United States
facility: The Mandell Center for Multiple Sclerosis
state: Connecticut
Study officials:
affiliation: Mandell Center for Multiple Sclerosis
name: Peter B Wade, MD
role: PRINCIPAL_INVESTIGATOR
References: