louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02346266: SMART (School-aged Children Making Healthy Choices And Recognizing sTroke)
Official title: SMART (School-aged Children Making Healthy Choices And Recognizing sTroke): A Pilot Trial of a Stroke Awareness Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
Stroke Prevention
Children
Education
Lead sponsor: Los Amigos Research and Education Institute
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 480
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: A stroke awareness program for school-aged children to learn the signs/symptoms of stroke, teach their parents and make healthy life-style choices.

Detailed description: 1. To educate school-aged children, grades 9th through 12th on the F.A.S.T. (Face, Arm, Speech and Time) acronym, additional signs and symptoms of stroke and the need for immediate activation of Emergency Medical Services (EMS) by calling 911.
2. To improve adults' stroke literacy through educating their children in grades 9th through 12th.

Eligibility criteria: Inclusion Criteria:

* High-school student

Exclusion Criteria:

* Not a high-school student

Primary outcomes:
measure: Child Improved Stroke Literacy
timeFrame: 3 weeks
Secondary outcomes:
measure: Adult Improved Stroke Literacy
timeFrame: 3 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02078466: Assessment of Functional Ability and Follow-up at Home for Older Medical Patients
Official title: Assessment of Functional Ability and Follow-up at Home for Older Medical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatric Disorder
Keywords: Functional assessment
readmission
acute care
older medical patients
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: VIA University College
name: Institute of public health, department of nursing sciences, Århus University, Denmark
First posted: 2014-03-05
Enrollment: 380
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to examine the effect of an intervention that consist of assessment of functional ability, rehabilitation plan and follow-up at home for older medical patients.

The hypothesis is that assessment of functional ability, development of rehabilitation plan and follow-up at home reduce the older medical patient's risk of readmission. Also the intervention is expected to reduce mortality, number of contacts to general practitioners and emergency physician


Eligibility criteria: Inclusion Criteria:

* Patients admitted to Medical Visitations Section (MVA) Aarhus University Hospital
* Aged 65+
* Resident in City of Aarhus

Exclusion Criteria:

* Patients admitted from nursing home
* Patients transferred to other hospital departments
* Patients terminally ill

Primary outcomes:
measure: Readmission
timeFrame: Readmission in 26 weeks
Secondary outcomes:
measure: Readmission
timeFrame: Readmission in 30 days
measure: Mortality
timeFrame: Mortality in 26 weeks
measure: Number of contacts with GP
timeFrame: 26 weeks
measure: Number of contacts with emergency Physician
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medicinsk Visitationsafsnit
Study officials:
affiliation: Center for Acute Research Aarhus University Hospital
name: Hans Kirkegaard, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nielsen LM, Maribo T, Kirkegaard H, Petersen KS, Lisby M, Oestergaard LG. Effectiveness of the "Elderly Activity Performance Intervention" on elderly patients' discharge from a short-stay unit at the emergency department: a quasi-experimental trial. Clin Interv Aging. 2018 Apr 26;13:737-747. doi: 10.2147/CIA.S162623. eCollection 2018.
Clinical trial NCT00501566: Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites
Official title: SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ascites
Liver Cirrhosis
Keywords: cirrhotic ascites
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-07-16
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites when used concomitantly with a standard dose regimen of spironolactone and furosemide.

The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.


Eligibility criteria: Inclusion Criteria:

* Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence
* Moderate or tense ascites
* Serum sodium of \>130 mmol/l.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Change in body weight
timeFrame: within 14 days
Secondary outcomes:
measure: Abdominal girth and discomfort
timeFrame: 14 days
measure: Paracentesis
timeFrame: 14 days
measure: Quality of life
timeFrame: 14 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis Administrative Office
city: Cove
country: Australia
facility: Sanofi-Aventis Administrative Office
state: New South Wales
city: Diegem
country: Belgium
facility: Sanofi-Aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
state: Quebec
city: Zagreb
country: Croatia
facility: Sanofi-Aventis Administrative Office
city: Praha
country: Czech Republic
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Budapest
country: Hungary
facility: Sanofi-Aventis Administrative Office
city: Milan
country: Italy
facility: Sanofi-Aventis Administrative Office
city: Bucuresti
country: Romania
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
Study officials:
References:
Clinical trial NCT03871166: Hemoglobin Concentration in Patients With an Acute Respiratory Distress Syndrome
Official title: Hemoglobin Concentration in Patients With an Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS, Human
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 1044
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients with ARDS and admitted to the ICUs of the Charité ARDS center will be enrolled in the study

Brief summary: Retrospective analysis of hemoglobin concentrations and red cell transfusion thresholds in patients with an Acute Respiratory Distress Syndrome (ARDS) admitted to an ARDS-center of a German university hospital.

Detailed description: Transfusion of packed red blood cells is a common procedure in critically ill patients. In recent years it has been shown that for many patient populations a restrictive transfusion strategy is not inferior compared to a liberal transfusion strategy with regard to overall outcome.

So far it is unclear whether patients with an ARDS should receive blood transfusions according to a restrictive or liberal transfusion strategy. Besides pulmonary gar exchange and cardiac output, the hemoglobin concentration is an important determinant for oxygen delivery.

The aim of this retrospective observational study is to analyze if low levels of hemoglobin/a restrictive transfusion strategy and are associated with a different mortality compared to higher levels of hemoglobin/a liberal transfusion strategy in patients with an ARDS.

Eligibility criteria: Inclusion Criteria:

* All adult patients with ARDS
* Admission to the Charité ARDS center

Exclusion Criteria:

* All patients \<18 years at the time of admission
* All patients with ARDS not admitted to the Charité ARDS center

Primary outcomes:
measure: Mortality
timeFrame: 01/2007 - 12/2018
Secondary outcomes:
measure: Failure-free days composites
timeFrame: 01/2007 - 12/2018
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum
Study officials:
affiliation: Charite University, Berlin, Germany
name: Jan A Graw, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hunsicker O, Materne L, Bunger V, Krannich A, Balzer F, Spies C, Francis RC, Weber-Carstens S, Menk M, Graw JA. Lower versus higher hemoglobin threshold for transfusion in ARDS patients with and without ECMO. Crit Care. 2020 Dec 16;24(1):697. doi: 10.1186/s13054-020-03405-4.
Clinical trial NCT02199366: Study of Cardiac MRI in Patients With Left-Sided Breast Cancer Receiving Radiation Therapy
Official title: Prospective Pilot Study of Early Markers of Radiation-Induced Cardiac Injury in Patients With Left-Sided Breast Cancer Receiving Photon or Proton Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Cardiac MRI
Radiation
Proton Radiation
Breast Cancer
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Ocala Royal Dames
First posted: 2014-07-24
Enrollment: 24
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: Radiation oncology clinic

Brief summary: This is a pilot study to determine if there are changes in heart function following completion of radiation therapy for breast cancer as measured by cardiac magnetic resonance imaging (cardiac MRI) scans. Additional purposes of this study are to assess cardiac side effects from radiation treatment, evaluate cardiac MRI changes by radiation technique, and compare quality of life questionnaires.

Detailed description: As part of this study, participants will have a cardiac MRI at baseline and a follow-up cardiac MRI within 1 year after completion of standard radiation therapy for left-sided breast cancer. The cardiac MRI scans will be evaluated to determine if there are changes in cardiac function within 1 year after radiation treatment.

Patients will be asked to complete a questionnaire before and after treatment that asks about their health and any symptoms they may be having.

Physical exams and any other standard of care service or treatment will be at the discretion of the treating physician.

Eligibility criteria: Inclusion Criteria:

* Left-sided breast cancer stage I-III.
* Indications for adjuvant regional nodal and breast or chest wall radiation therapy (RT).
* Women and men are allowed.
* Must be at least 18 years old at time of consent.

Exclusion Criteria:

* Pregnant and/or breastfeeding women or patients of child-producing potential not willing to use contraception while on study.
* Prior history of cardiovascular disease per physician discretion.
* Stage 0 and IV breast cancer.
* Prior radiation therapy to chest.
* Concurrent trastuzumab per physician discretion.

Primary outcomes:
measure: Proportion of participants with changes in cardiac function.
timeFrame: 1 year after completion of radiation therapy
Secondary outcomes:
measure: Proportion of patients with serious cardiac side effects.
timeFrame: 1 year after completion of radiation therapy
measure: Mean quality of life score.
timeFrame: 1 year after radiation treatment
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Julie A Bradley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02727166: Effect of Chicory-derived Inulin on Abdominal Sensations and Bowel Motor Function
Official title: Efecto de Fructanos Paralelamente Hidrolizados Provenientes de Achicoria Sobre Las Sensaciones Abdominales
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Keywords: intestinal gas
functional gut symptoms
intestinal sensitivity
intestinal motility
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 67
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects with gas-related complaints exhibit impaired handling of intestinal gas loads and we hypothesized that inulin would have a beneficial effect. Aim: to determine the effect of a prebiotic chicory-derived inulin-type fructan on the tolerance of intestinal gas. Methods. Placebo-controlled, parallel, randomized and double-blind trial study. Subjects with abdominal symptoms and reduced tolerance of intestinal gas (selected by a pre-test) will receive either inulin (8 g/d, n=18) or maltodextrin as a placebo (8 g/d, n=18) for 4 wk. A gas challenge test (4 h jejunal gas infusion at 12 mL/min while measuring abdominal symptoms and gas retention for 3 h) will be performed before and at the end of the intervention phase. Gastrointestinal symptoms and bowel habits (using daily questionnaires for 1 wk) and fecal bifidobacteria counts will be measured before and at the end of the intervention.


Eligibility criteria: Inclusion Criteria:

* negative sensation of digestive well-being (score ≤ 1 on at least 2 of the 6 evaluation days, scored on a - 5 / +5 scale.
* poor tolerance of a gas challenge test (abdominal perception score ≥ 3, on a 0-6 scale, for at least three 15-min time points over the last 90 minutes of the 180-minute-long intestinal gas infusion test).

Exclusion Criteria:

* antibiotic intake,
* exceptional diets,
* changes in dietary habits or intake of Ca supplements over the preceding month.

Primary outcomes:
measure: Perception of intestinal gas infusion
timeFrame: 60 last min of the 180 min gas infusion test
Secondary outcomes:
measure: Intestinal gas retention
timeFrame: 60 last min of the 180 min gas infusion test
measure: Digestive well-being
timeFrame: 6 last days of intervention
measure: Abdominal discomfort
timeFrame: 6 last days of intervention
measure: Bowel habit
timeFrame: 6 last days of intervention
Other outcomes:
Locations:
Study officials:
affiliation: Vall d'Hebron Research Institute
name: Fernando Azpiroz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05550766: Prognostic Value of RXR-α in Cutaneous Squamous and Basal Cell Carcinoma
Official title: Prognostic Value of RXR-α in Cutaneous Squamous and Basal Cell Carcinoma: An Immunohistochemical Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-melanoma Skin Cancer
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Blocks obtained from cutaneous basal and squamous cell carcinoma tissue from 50 patients.

Brief summary: Vitamin D has a crucial role in cancer control and prevention.vitamin D receptor (VDR) and its heterodimer Retinoid X receptor (RXR) are equally important in the cell. This ligand (vitamin D) and receptors (VDR-RXR) complex together triggers downstream DNA damage response in the cell.

Retinoid receptors are a superfamily of nuclear receptors. The preferred receptor that attaches to VDR is RXR, with its subunits α, β and γ. RXR α is more frequent in the skin than other tissues, while β occurs in internal organs and γ is frequently related to neural disorders.

the investigator hopes to assess prognosis of SCC \& BCC by using RXR-α biomarker \& attempts to use it in the treatment.


Eligibility criteria: Inclusion Criteria:

1. Squamous cell carcinoma and basal cell carcinoma.
2. Incisional \& excisional biopsies.
3. All the studied cases include sufficient materials for the immunohistochemical study 4. Complete clinical data

Exclusion Criteria:

1. Patients with a history of preoperative chemotherapy and/or radiotherapy.
2. Insufficient or tiny tissue biopsies.

Primary outcomes:
measure: Prognostic Value of RXR-α in Cutaneous Squamous and Basal Cell Carcinoma
timeFrame: One or two days after staining sections with the marker.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00263926: Efficacy and Safety of a Purified Standardised Wasp Venom Preparation
Official title: Immunotherapy of Wasp Venom Allergy: Comparison of a Purified Preparation to Conventional Aqueous Wasp Venom in an Open Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Keywords: Wasp venom allergy,
specific immunotherapy
Lead sponsor: Allergopharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2005-12-12
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: The trial is performed to assess efficacy and safety of a purified standardised wasp venom preparation in wasp venom allergy


Eligibility criteria: Inclusion Criteria:

* History of wasp venom allergy,
* Positive RAST to wasp venom,
* Positive skin prick test to wasp venom

Exclusion Criteria:

* Serious chronic diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Reinbek
country: Germany
facility: Allergopharma GmbH & Co. KG
Study officials:
name: Annemie Narkus, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04643626: The Impact of Artificial Intelligence Dietary Smartphone Application on Nutritional Status Among Cancer Patients
Official title: The Impact of Artificial Intelligence Dietary Smartphone Application on Nutritional Status Among Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition, Calorie
Malnutrition; Protein
Weight Change, Body
Keywords: artificial intelligence dietary application
weight
oral intake
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, Malaysia
First posted: 2020-11-25
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center prospective pilot trial study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Multi-center prospective pilot trial study

Detailed description: This is a clinical study to evaluate impact of dietary smartphone application on nutritional status among cancer patients. the study hypotheses there is improvement in nutritional outcome in intervention group if compare with control group. the eligible subjects will be screened according to inclusion criteria and approached individually to participate in this study. The consented subjects will be divided randomly into two groups, intervention and conventional groups. Conventional dietitian care will be given to conventional group (CG) while intervention group (IG) will received innovated dietitian care where they will be introduced with iDSA apps and installed in consented subjects' smartphone. All subjects will be reviewed again by dietitian in 1-month time to assess nutritional status (weight and energy protein intake) as well as nutrition impact symptoms.

Eligibility criteria: Inclusion Criteria:

* Possessing smartphone and is willing to use smartphone application
* Been referred to dietitian in outpatient clinic
* At least 18 years of age
* Malaysian

Exclusion Criteria:

* Inability to use the smartphone application (eg. due to vision problems)
* Not been referred to dietitian in outpatient clinic
* Patients who participate in other study at the same time
* On nutrition support (enteral / intra-venous)
* Vulnerable subjects

Primary outcomes:
measure: weight changes
timeFrame: one month
measure: daily energy intake
timeFrame: one month
measure: daily protein intake
timeFrame: one month
Secondary outcomes:
measure: PG-SGA score
timeFrame: one month
measure: Nutrition Impact Symptoms (NIS)
timeFrame: one month
Other outcomes:
Locations:
city: Putrajaya
country: Malaysia
facility: National Cancer Institute
state: Wilayah Persekutuan Putrajaya
Study officials:
affiliation: National Cancer Insitute, Malaysia
name: Chiou Yi Ho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03572426: Ion Channel Genetic Biomarkers: Diagnostic Capabilities in the Assessment of Bipolar Disorder
Official title: Ion Channel Genetic Biomarkers: Diagnostic Capabilities in the Assessment of Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Sigma Theta Tau
First posted: 2018-06-28
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caucasian and Latino

Brief summary: Genotype 164 adults to evaluate six selected single nucleotide polymorphisms (SNPs) (rs1006737, rs10994336, rs10994133, rs2238071, rs1051375, rs1024582) for use as a genetic biomarker to differentiate between bipolar depression and unipolar depression.

Detailed description: Adults ages 18-80 will be recruited if they are diagnosed with bipolar disorder, major depression, or have no mood symptoms. The adults will undergo a diagnostic interview, the Mini International Neuropsychiatric Interview (MINI) for the diagnosis. The subjects will also complete the Adverse Childhood Events Scale to evaluate for a genetic x environmental interaction in detecting bipolar disorder at initial assessment. Genotyping will be done by SNaPshot genotyping method and genetic sample will be collected via buccal swab.

Eligibility criteria: Inclusion Criteria:

* presenting to one of 4 Denver Metro Area clinics
* Subjects must fall into one of 3 diagnostic categories, bipolar, MDD, or no mood symptoms.

Exclusion Criteria:

* Inability to provide informed consent
* history of TBI
* history of untreated seizure disorder
* substance abuse in the last 8 hours
* moderate-severe substance abuse disorder diagnosed in the last 6 months

Primary outcomes:
measure: Logistic Regression
timeFrame: 1 year
Secondary outcomes:
measure: Genetic Risk Score
timeFrame: 1 year
measure: Family History
timeFrame: 1 year
measure: Adverse Childhood Experiences Scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Helen and Arthur E Johnson Depression Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Kristiana Avery, PhD-c
role: PRINCIPAL_INVESTIGATOR
References: