louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01825343: Preventable Paediatric Trauma - Retrospective Analysis
Official title: Preventable Paediatric Trauma - Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Trauma
Keywords: fall
burn
road traffic crash
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2013-04-05
Enrollment: 1000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Identify from the Trauma database all patients assessed at Ziv Medical Centre with Trauma, consult their medical notes and document the exact injury, the mechanism of injury, the circumstances, whether the child was alone or supervised, the nature and complications of the injury, treatment required and short and long term progress and disability.

Brief summary: Purpose: a retrospective study of all Paediatric patients who presented to Ziv Medical Centre with injuries of all systems, major and minor, in order to determine the exact circumstances of the injury, whether this might have been preventable and design a Haddon Matrix of risk factors for injury to target prevention.

Hypothesis: injury prevention interventions can be targetted by finding out local causes of Paediatric Trauma

Detailed description: A Trauma Registry is already kept in the hospital. It is confidential and data is supplied to the government from this registry.

The procedure is to be granted access to the database and access data stored on the mechanism and outcome of Paeditric Trauma. This data will be stored on the work computer of the principal investigator and will be password protected.

Methods: Identify from the Trauma database all patients assessed at Ziv Medical Centre with Trauma, consult their medical notes and document the exact injury, the mechanism of injury, the circumstances, whether the child was alone or supervised, the nature and complications of the injury, treatment required and short and long term progress and disability.

Eligibility criteria: Inclusion Criteria:

* All patients classified as Paediatric according to Israeli law (up to the age of 18 years). This includes pregnant women and patients presenting with multiple complaints as well as Trauma, isolated injuries and polytrauma.

Exclusion Criteria:

* Patients for whom no history is available.

Primary outcomes:
measure: Establishing exact mechanism of injury
timeFrame: 5 years (2007-2012)
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Ziv Hospital
state: Galilee
Study officials:
affiliation: Specialist Surgeon
name: Wajdi Safadi, MD
role: STUDY_CHAIR
affiliation: Specialist Surgeon
name: Seema Biswas, FRCS
role: STUDY_DIRECTOR
affiliation: Senior Surgeon
name: Amram Hadary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of Department
name: Igor Waksman, MD
role: STUDY_CHAIR
affiliation: Ziv Hospital Trauma Coordinator
name: Dudu Fuchs, RN
role: STUDY_CHAIR
References:
Clinical trial NCT06340243: Risk Adapted Therapy of Hodgkin Lymphoma in Upper Egypt
Official title: Risk Adapted Therapy of Hodgkin Lymphoma in Upper Egypt
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pediatric Hodgkin Lymphoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants and children around age of (1month to 18 years old) admitted with hodgkin lymphoma in a period of 2 years

Brief summary: determine if radiotherapy could be safely omitted for early hodgkin lymphoma responder patients without compromising outcome

Detailed description: Hodgkin's lymphoma accounts for around 40% of all pediatric lymphomas and is the most prevalent cancer among adolescents and young adults. With combinations of chemotherapy and radiation, Hodgkin's lymphoma is roughly 80% curable, placing it among the most treatable cancers . Since the introduction of combination chemotherapy treatments 20 years ago, the prognosis for children with Hodgkin's lymphoma has improved. The treatment is mostly influenced by the stage of the disease at diagnosis, histology, existence of "B"-symptoms, and the presence of bulky disease. Nonetheless, 20% of patients do not achieve long-term remission, and around 20% experience treatment-related side effects such as secondary malignancies, infertility, cardiovascular disease, and organ malfunction following chemo-radiation .Studies of long-term therapy side effects were made possible by the significant number of survivors. The goal of therapy optimization protocols for pediatric patients with Hodgkin's lymphoma is to maintain excellent tumor control while limiting adverse effects and long-term consequences . It is critical to stratify patients based on reliable prognostic factors at presentation and according to the rapidity of response into low-risk (LR) patients who would benefit from less aggressive therapy, avoiding unnecessary toxic side effects, and high-risk (HR) patients who should be subjected to intensified therapy to reduce the rate of treatment failures and relapses .

Eligibility criteria: Inclusion Criteria:

* Previously untreated patients younger than 18 years old with classical Hodgkin lymphoma

Exclusion Criteria:

* Patients aged more than 18 years old.
* Patients who died early at presentation before starting chemotherapy
* diagnosis of nodular lymphocytic predominant Hodgkin lymphoma
* previous chemotherapy or radiotherapy other (simultaneous) malignancies
* severe concomitant diseases (eg, immune deficiency syndrome); or known HIV positive.

Primary outcomes:
measure: assess the outcome of pediatric patients with HL treated with risk- and response-adjusted therapy
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04040543: Development of a Marker of Adherence for Tracking Consumption of Nutrient Supplements
Official title: Development of a Biomarker to Assess Adherence to Nutrients Supplements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence, Treatment
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2019-07-31
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether selected adherence markers can be used to track daily or intermittent consumption of nutrient supplements.

Detailed description: The investigators will assess whether urinary concentrations of selected adherence markers can be used to distinguish between daily or intermittent consumption of lipid-based nutrient supplements.

Eligibility criteria: Inclusion Criteria:

* non-pregnant, non-lactating women

Exclusion Criteria:

* BMI \<18.5kg/m2 or \>25.0 kg/m2
* Diagnosis of chronic disease
* Use of medication that can affect gastrointestinal mobility
* Consumption of more than 7 alcoholic drinks per week
* Smoking
* Unwillingness to refrain from consuming dietary sources of the marker compound(s) 3 days prior to, and during the 12 day urine collection period
* Unwillingness to adhere to the study protocol
* Peanut allergy
* Cow milk allergy
* Soy allergy
* Almond allergy
* Allergy to adherence markers
* Pregnancy

Primary outcomes:
measure: urinary concentration of saccharin (nmol/L)
timeFrame: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
measure: urinary concentration of saccharin (nmol/g creatinine)
timeFrame: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
measure: urinary concentration of resveratrol metabolites (nmol/L)
timeFrame: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
measure: urinary concentration of resveratrol metabolites (nmol/g creatnine)
timeFrame: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
Secondary outcomes:
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Marjorie Haskell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02957643: Substitution of the Normal Levels of Iron and Hemoglobin in Pregnant Women With Iron Supplement
Official title: Treatment of Iron Defieciency Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prevention of Anemia
Lead sponsor: Hippocration General Hospital
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the hemoglobin, hematocrit and iron in serum and assess the course of treatment.

Detailed description: The purpose of the study is to investigate the effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the hemoglobin, hematocrit and iron in serum and assess the course of treatment

Eligibility criteria: Inclusion Criteria:

1. Age more or equal of 18 years
2. Registration consent
3. Have complete 12h week of pregnancy
4. Hemoglobin levels \<10,5 ptl
5. Hematocrit \< 32 %

Exclusion Criteria:

1. Age \<18 years
2. Absent registration consent
3. Step of pregnancy less than 12 weeks
4. Coadministration formulations iron oral or parenterally
5. Background of liver kirrosis
6. Background of aimosidirosis
7. Background acquired or chronic aimatochromatosis
8. Aplastic , Hemolytic anemia and chronic diseases
9. Chronic pancreatitis
10. Subjective renal or/and liver disease
11. Hypothyroidism or yperthyreoeidismos

Primary outcomes:
measure: Measured and reported effectiveness of iron in the treatment of iron deficiency in pregnant 2nd and 3rd quarter with questionnaire
timeFrame: up to 24 months
Secondary outcomes:
measure: adverse reactions
timeFrame: up to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: PANAGIOTIS MATSOUKATIDIS, MD,Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Aristotle University Of Thessaloniki
name: CHARALABOS KOLVATZIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03090490: 10-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals
Official title: Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: a 10-year Follow-up
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Schizophrenia Relapse
Schizophrenia Spectrum and Other Psychotic Disorders
Keywords: Treatment
Maintenance
Lead sponsor: Fundación Marques de Valdecilla
Sponsor class: OTHER
Collaborators: name: Centro de Investigación Biomédica en Red de Salud Mental
name: Instituto de Investigación Marqués de Valdecilla
First posted: 2017-03-24
Enrollment: 68
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This open-label, non-randomized, prospective study will evaluate the risk of symptoms recurrence during the ten years after antipsychotic discontinuation in a sample of functionally recovered first-episode patients with schizophrenia spectrum disorder.


Eligibility criteria: Inclusion Criteria:

* Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the University Hospital Marqués de Valdecilla (Santander, Spain).
* A minimum of 18 months on antipsychotic treatment.
* Meeting clinical remission criteria for at least the 12 months prior to inclusion.
* Meeting the functional recovery criteria for at least the 6 months prior to inclusion.
* Stabilized at the lowest effective doses for at least the 3 months prior to inclusion.

Exclusion Criteria:

* Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for drug dependence.
* Meeting DSM-IV criteria for mental retardation.
* Having a history of neurological disease or head injury.

Primary outcomes:
measure: Relapse rate
timeFrame: At 10 years
Secondary outcomes:
measure: Change in general psychopathology measured by BPRS
timeFrame: At 10 years
measure: Change in overall clinical status measured by CGI
timeFrame: At 10 years
measure: Change in negative symptoms measured by SANS
timeFrame: At 10 years
measure: Change in negative symptoms measured by SAPS
timeFrame: At 10 years
measure: Time to relapse
timeFrame: At 10 years
measure: Functionality status measured by DAS
timeFrame: At 10 years
Other outcomes:
Locations:
city: Santander
country: Spain
facility: University Hospital Marques de Valdecilla
state: Cantabria
Study officials:
affiliation: University Hospital Marqués de Valdecilla, IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain. CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain
name: Benedicto Crespo-Facorro, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05803590: Compare the Effect of Green Tea Mouthwash vs Chlorohexidine Mouthwash in Children With Plaque-induced Gingivitis
Official title: Comparative Effect of Green Tea Versus Chlorhexidine Mouthwash on Plaque Induced Gingivitis In a Group of Egyptian Children: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plaque Induced Gingivitis
Keywords: green tea
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess and compare the effect of green tea mouthwash compared to chlorohexidine mouthwash in reducing gingivitis and plaque scores (in terms of plaque index and gingival index) in children with plaque-induced gingivitis.

Detailed description: This study aims to assess and compare the effect of green tea mouthwash compared to chlorohexidine mouthwash in reducing gingivitis and plaque scores (in terms of plaque index and gingival index) in children with plaque-induced gingivitis.

This study will be conducted in the outpatient clinics of the Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry, Cairo University - Egypt.

Patients attending the outpatient clinic in Pediatric Dentistry and Dental Public health Department - Faculty of Dentistry - Cairo University - Egypt will be screened until the target population is achieved.

Eligibility criteria: Inclusion Criteria:

* Children aged 10-14 years.
* Children with a gingival index score of ≥ 1 and a plaque index score of ≥ 1.
* Children in good medical health and free from major oral hard or soft tissue lesions. \[Medically fit children (ASA I, II)\].
* Children classified as cooperative or potentially cooperative according to Wright's classification of child behavior.
* Children mentally capable of communication.

Exclusion Criteria:

* Parental refusal for participation.
* Children under antibiotics treatment during the last six weeks prior to the study.
* Children wearing fixed or removable orthodontic devices.
* Patients who underwent oral prophylaxis in the last six months.

Primary outcomes:
measure: Gingivitis will be recorded by the Gingival index
timeFrame: one hour
Secondary outcomes:
measure: Presence of dental plaque will be recorded by the Plaque index
timeFrame: one hour
Other outcomes:
measure: Patient Satisfaction using a questionnaire
timeFrame: one hour
Locations:
Study officials:
References:
Clinical trial NCT00088790: AZD5438 in Patients With Advanced Solid Malignancies
Official title: Phase I Study to Assess the Safety and Tolerability of AZD5438 in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: advanced, solid, malignancies
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2004-08-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Purpose of this study is to assess the safety and tolerability of AZD5438 given orally to patients with advanced solid malignancies A review of the emerging clinical tolerability and exposure data from this study in conjunction with preclinical and the available clinical pharmacodynamic data relating to AZD5438, led to a decision by AstraZeneca that the development of AZD5438 as a potential anti-cancer agent would be discontinued.


Eligibility criteria: Inclusion Criteria:

* Advanced solid malignancy
* Cancer refractory to standard treatments or for which no standard therapy exits

Exclusion Criteria:

* Radiotherapy within 3 weeks of the start of treatment
* Investigational product within the last 3 weeks
* Systemic cytotoxic anti-cancer therapy within the last 3 weeks
* Any significant clinical disorder that makes it undesirable for the patient to participate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: New York City
country: United States
facility: Research Site
state: New York
Study officials:
References:
Clinical trial NCT03758690: High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth
Official title: Efficacy of Abdominal Treatment With High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Tone Increased
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2018-11-29
Enrollment: 10
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of use of the High-Intensity Focused Electromagnetic (HIFEM) Field Device in women after childbirth.


Eligibility criteria: Inclusion Criteria:

* Non-breastfeeding women 3-36 months after childbirth
* Voluntarily signed informed consent form
* BMI ≤ 30 kg/m2
* Women of child-bearing potential are required to use birth control measures during the whole duration of the study
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
* Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation

Exclusion Criteria:

* Cardiac pacemakers
* Implanted defibrillators, implanted neurostimulators
* Electronic implants
* Pulmonary insufficiency
* Metal implants
* Drug pumps
* Application in the head area
* Application in the heart area
* Malignant tumor
* Fever
* Pregnancy
* Breastfeeding
* Following recent surgical procedures when muscle contraction may disrupt the healing process
* Application over areas of the skin which lack normal sensation
* Scars, open lesions and wounds at the treatment area
* Unrepaired abdominal hernia
* Patients after Cesarean section delivery

Primary outcomes:
measure: Effectiveness of the device for abdominal toning according to MRI images
timeFrame: 7 months
measure: Effectiveness of the device for abdominal toning according to waist circumference measurements
timeFrame: 7 months
Secondary outcomes:
measure: Subject's satisfaction with study treatment: Questionnaire
timeFrame: 7 months
measure: Determination of side effects and adverse events (AE) associated with the study device.
timeFrame: 7 months
Other outcomes:
Locations:
city: Macon
country: United States
facility: Skin Care Physicians of Georgia
state: Georgia
city: Chicago
country: United States
facility: Chicago Cosmetic Surgery and Dermatology
state: Illinois
Study officials:
References:
Clinical trial NCT05516290: Evaluating Clinical Trial Experiences of Individuals With Congestive Heart Failure
Official title: An In Depth Study Investigating Patterns of Patients In Congestive Heart Failure Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Congestive Heart Failure
Keywords: congestive heart failure
heart failure
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Congestive Heart Failure patients who are actively considering enrolling in an interventional clinical trial, but have not yet completed enrollment and registration.

Brief summary: Clinical trial participation has always been substantially skewed toward certain demographic groups. However, there has been little study on whether trial qualities impact participation in either a positive or negative way. The goal of this research is to identify the characteristics that consistently restrict patients' ability to participate in or complete a trial in which they were initially interested. This data will be evaluated via a number of demographic lenses in order to find trends that could benefit future Congestive Heart Failure sufferers.


Eligibility criteria: Inclusion Criteria:

* Lives in the United States
* Is 18+ years old
* Participant has a diagnosis of congestive heart failure
* Participant has enrolled in an interventional clinical for congestive heart failure (self-reported)

Exclusion Criteria:

* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
* No diagnosis of congestive heart failure confirmed

Primary outcomes:
measure: Number of patient decides to enroll in a congestive heart failure clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in a congestive heart failure clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Betkowski AS, Hauptman PJ. Update on recent clinical trials in congestive heart failure. Curr Opin Cardiol. 2000 Jul;15(4):293-303. doi: 10.1097/00001573-200007000-00015.
citation: White M, Rouleau JL. Overview of clinical trials in congestive heart failure. Can J Cardiol. 1993 Sep;9(7):629-34.
citation: Samman Tahhan A, Vaduganathan M, Kelkar A, Georgiopoulou VV, Kalogeropoulos AP, Greene SJ, Fonarow GC, Gheorghiade M, Butler J. Trends in Heart Failure Clinical Trials From 2001-2012. J Card Fail. 2016 Mar;22(3):171-9. doi: 10.1016/j.cardfail.2015.06.014. Epub 2015 Jun 21.