louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06184178: Implementing the Transcultural Social-Ethical-Care Model -TEC-MED for Older People in the Mediterranean Basin
Official title: Implementing the Transcultural Social-Ethical-Care Model -TEC-MED for Older People in the Mediterranean Basin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older People
Care Dependency
Social Exclusion
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 20000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Implementation of the TEC-MED model of social and health care in the elderly population of the Mediterranean basin through a quasi-experimental trial. Participants will be assigned to the intervention group and will receive comprehensive care and assessment under the TEC-MED care model. Participants in the control group will receive usual care during the data collection phase, but will be offered care under the TEC-MED model at the end of the project.


Eligibility criteria: Inclusion Criteria:

* 60 years or more
* Living in the Mediterranean Basin countries

Exclusion Criteria:

* None

Primary outcomes:
measure: Care Dependency Level
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life level
timeFrame: 3 months
Other outcomes:
Locations:
city: Seville
country: Spain
facility: University of Seville
Study officials:
affiliation: University of Seville
name: Regina Allande-Cussó, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02286778: Eradication of Malignant Carcinoma in the Breast Tissue
Official title: The Eradication of Malignant Carcinoma in the Breast Tissue Using an ATP (Adenosine-5'-Triphosphate) Inhibitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Lead sponsor: Optimal Health Research
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
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 confirm the findings of an early study and expand our knowledge of treating Malignant Carcinoma in the Breast Tissue Using an ATP (Adenosine-5'-Triphosphate) Inhibitor.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of breast cancer
* Referred to the study by their treating physician

Exclusion Criteria:

* Any type of treatment for breast cancer before starting the study

Primary outcomes:
measure: Number of participants tumor free
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Optimal Health Research
name: John A Shaw, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Optimal Health Research
name: Steven Osguthorpe, ND
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00188578: Intensity Modulated Radiation Therapy - Gyne Cancer (GY03.2)
Official title: A Pilot Study of Conformal Intensity Modulated Radiation Therapy (IMRT) for Gynaecological Cancer Patients Not Suitable for Intracavitary Brachytherapy Boost (GY03.2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cervix Neoplasms
Uterine Neoplasms
Vaginal Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2005-09-16
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Standard treatment for gynecological cancer is radiation therapy in two phases; whole pelvic radiation and then an internal radiation boost, also called a brachytherapy boost, to treat any remaining tumour.

The purpose of this study is to test an alternative radiation boost treatment called conformal intensity modulated radiation therapy or IMRT. Currently, we do not have complete information on the overall effectiveness of IMRT compared to brachytherapy or conformal radiotherapy. We know that IMRT allows the radiation beams to be more accurately focused on the tumor, thereby sparing more normal tissue from radiation damage and lowering risks of side effects. We are investigating the extent to which IMRT can be used to protect normal tissues in patients with cervix, uterine or vaginal cancer from the radiation beams and how much the side effects of radiation are reduced.


Eligibility criteria: Inclusion Criteria:

* Biopsy-proven carcinoma of the cervix, uterus or vagina; FIGO stage T1B-4A, NO/1, MO, treated with definitive radiotherapy with or without chemotherapy, or Biopsy-proven pelvic recurrence of carcinoma of the uterus previously untreated or biopsy-proven vaginal carcinoma treated radically with radiotherapy but unsuitable for brachytherapy boost.
* Patients not suitable for intracavitary brachytherapy.
* ECOG performance status of 0, 1, or 2
* Age ≥ 18 years
* Ability to give informed consent.

Primary outcomes:
measure: To evaluate the feasibility of using IMRT to boost the primary tumour in patients with gynecological cancers who are unsuitable for brachytherapy.
timeFrame: 5 years
Secondary outcomes:
measure: To evaluate the acute and late toxicity of IMRT boost.
timeFrame: 5 years
measure: To evaluate tumour response and patient survival data.
timeFrame: 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Anthony Fyles, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Princess Margaret Hospital
name: Michael Milosevic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05476978: Artificial Intelligence in EUS for Diagnosing Pancreatic Solid Lesions
Official title: Utilization of Artificial Intelligence for the Development of an EUS-convolution Neural Network Model Trained to Differentiate Pancreatic Cancer From Other Pancreatic Solid Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Ductal Adenocarcinoma
Pancreatitis, Chronic
Pancreatic Neuroendocrine Tumor
Autoimmune Pancreatitis
Keywords: artificial intelligence
endoscopic ultrasound
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: LanZhou University
First posted: 2022-07-27
Enrollment: 130
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: The cohort will be selected from Tongji Hospital, Tongji Medical College, HUST.

Brief summary: We aim to develop an EUS-AI model which can facilitate clinical diagnosis by analyzing EUS pictures and clinical parameters of patients.

Detailed description: EUS is considered to be a more sensitive modality than CT in detecting pancreatic solid lesions due to its high spatial resolution. However, the diagnostic performance is largely dependent on the experience and the technical abilities of the practitioners. Therefore, we aim to develop an objective EUS diagnostic model based on the convolutional neural network, an artificial intelligence technique. In addition, clinical parameters such as risk factors, tumor biomarkers and radiology findings are also added to this artificial intelligence model in order to mimic the actual clinical diagnosis procedures and to increase the performance of this model.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent EUS using a curved line array echoendoscope (GF-UCT260; Olympus Medical Systems) since 2014 in our affiliation.
* For each patient, all available native EUS pictures are included.
* Patients' diagnosis are validated by surgical outcomes or fine-needle aspiration (FNA) findings and have a compatible clinical course with a follow-up period of more than 6 months.

Exclusion Criteria:

* The image is of poor quality.
* The images contain unique marks which can potentially bias the model, such as the biopsy needle.

Primary outcomes:
measure: The model's ability to differentiate pancreatic cancer from other pancreatic solid lesion
timeFrame: After the training process of the EUS-AI model is completed
Secondary outcomes:
measure: The model's ability to specify the pancreatic solid lesions such as pancreatic cancer, CP, AIP and NET
timeFrame: After the training process of the EUS-AI model is completed
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT01979978: Healthy Buddies Manitoba
Official title: Healthy Buddies Manitoba: A Cluster Randomized Controlled Effectiveness Trial of Peer Mentoring for Healthy Eights in Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Children
Elementary School Age
Rural and Urban
First Nations
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 647
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: School-based interventions are generally ineffective for preventing weight gain in children. In 2007, a group from the University of British Columbia, developed a program called Healthy Buddies, that relied on peer mentors to help young children adopt healthy living behaviours. Pilot studies revealed that the program effectively prevented weight gain in children. This trial had never been tested on a large scale using a more scientifically sound study design. We developed a large school-based randomized trial to overcome that limitation and test the hypothesis that that a school-based peer-led healthy living program would reduce adiposity and increase physical activity among children 6-12yrs old.


Eligibility criteria: Inclusion Criteria:

* Participating schools need to meet the following eligibility criteria: (1) were within provincial jurisdiction, (2) had a minimum of 200 students per school, (3) offered grades 1 through 6.

Exclusion Criteria:

* Children will be excluded if consent was not received from parents or if they had a condition that limited participation in physical activity.

Primary outcomes:
measure: Waist circumference
timeFrame: 10 months
measure: BMI-Z score
timeFrame: 10 months
Secondary outcomes:
measure: Physical activity
timeFrame: 10 months
measure: Healthy living knowledge and behaviours
timeFrame: 10 months
measure: Self efficacy
timeFrame: 10 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Manitoba Institute of Child Health - University of Manitoba
state: Manitoba
Study officials:
affiliation: Healthy Child Manitoba
name: Rob Santos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Manitoba Institute of Child Health
name: Jon McGavock, PhD
role: STUDY_DIRECTOR
References:
citation: Nickel NC, Doupe M, Enns JE, Brownell M, Sarkar J, Chateau D, Burland E, Chartier M, Katz A, Crockett L, Azad MB, McGavock JM, Santos R. Differential effects of a school-based obesity prevention program: A cluster randomized trial. Matern Child Nutr. 2021 Jan;17(1):e13009. doi: 10.1111/mcn.13009. Epub 2020 Aug 20.
citation: Santos RG, Durksen A, Rabbanni R, Chanoine JP, Lamboo Miln A, Mayer T, McGavock JM. Effectiveness of peer-based healthy living lesson plans on anthropometric measures and physical activity in elementary school students: a cluster randomized trial. JAMA Pediatr. 2014 Apr;168(4):330-7. doi: 10.1001/jamapediatrics.2013.3688.
Clinical trial NCT01474278: A Study of RO5028442 in Adult Male High-Functioning Autistic Patients
Official title: A Multi-centre, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over, Exploratory Biomarker and Safety and Tolerability Study of a Single Dose of RO5028442 in Adult Male High-functioning Autistic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Autistic Disorder
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-11-18
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This multi-center, randomized, double-blind study will evaluate exploratory biomarkers and the safety and tolerability of a single dose of RO5028442 in adult male high-functioning autistic patients. In a cross-over design, patients will be randomized to receive either a single dose of RO5028442 or matching placebo with a washout period of 7-14 days. Anticipated time on study is up to approximately 9 weeks.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of Autistic Disorder as defined by DSM-IV, confirmed by the team and supported with the Autistic Diagnostic Observation Schedule (ADOS)
* Male adults, 18 to 45 years of age
* IQ \> 70 (Wechsler Adult Intelligence Scale-Full scale)
* Body mass index (BMI) 18 to 35 kg/m2 inclusive
* Aberrant Behavior Checklist (ABC) - Irritability subscale score \</= 13

Exclusion Criteria:

* Positive urine test for drugs of abuse
* Alcohol and/or substance abuse/dependence during the last 12 months
* Positive for hepatitis B, hepatitis C or HIV infection
* Clinically relevant cardiovascular, renal, hepatic or hematologic disease or disorder
* Active inflammatory pulmonary disease
* History of epilepsy/seizure disorder (except for simple febrile seizures)
* Initiation of new or major change in psychosocial intervention within 4 weeks prior to randomization
* Treatment with any investigational agent within 90 days prior to screening
* History of hypersensitivity or allergic reactions

Primary outcomes:
measure: Efficacy: Behavior assessments
timeFrame: up to 24 hours post-dose
measure: Safety: Incidence of adverse events
timeFrame: up to 24 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Los Ageles
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Bronx
country: United States
state: New York
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Umbricht D, Del Valle Rubido M, Hollander E, McCracken JT, Shic F, Scahill L, Noeldeke J, Boak L, Khwaja O, Squassante L, Grundschober C, Kletzl H, Fontoura P. A Single Dose, Randomized, Controlled Proof-Of-Mechanism Study of a Novel Vasopressin 1a Receptor Antagonist (RG7713) in High-Functioning Adults with Autism Spectrum Disorder. Neuropsychopharmacology. 2017 Aug;42(9):1914-1923. doi: 10.1038/npp.2016.232. Epub 2016 Oct 6.
Clinical trial NCT00986778: Entecavir Plus Adefovir in Lamivudine-Resistant Patients
Official title: A Comparative Study of Entecavir vs Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Chinese Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-09-30
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant chronic hepatitis B infection


Eligibility criteria: Inclusion Criteria:

* CHB HBeAg(+) Subject with Lamivudine treatment history must have LVDr substitution at rtM204V/I
* Naïve to nucleoside/nucleotide analogues except for LVD
* HBV DNA \> 17,200 IU/mL
* Compensated liver function
* Serum ALT \<10 × ULN

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Evidence of decompensated cirrhosis
* Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)

Primary outcomes:
measure: The proportion of patients with HBV DNA < 50 IU/mL at W48
timeFrame: Week 48
Secondary outcomes:
measure: The proportion of patient with HBV DNA < 50 IU/mL at W 96
timeFrame: Week 96
measure: Mean reduction of HBV DNA at W 48 & 96
timeFrame: Week 48 and 96
measure: The proportion of subjects with ALT normalization at W 48 & 96
timeFrame: Week 48 & Week 96
measure: The proportion of subjects achieved HBeAg loss, seroconversion, HBsAg loss and seroconversion at W48 & 96
timeFrame: Week 48 & 96
measure: Safety
timeFrame: Week 48 and Week 96
measure: Resistance
timeFrame: Week 48 & Week 96
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04672278: Lipid-Lowering Effect and Hypotensive Effect of Shanzha Fruit Drink in Patients
Official title: A Randomized, Double-Blind, Placebo-Controlled Cross-Over Study to Evaluate the Safety, Lipid-Lowering Effect and Hypotensive Effect of Shanzha Fruit Drink in Patients With Mild to Moderate Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemia
Hypertension
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single-center, randomized, double-blind, placebo-controlled, cross-over study. Subjects who meet the inclusion/exclusion criteria will be randomly and alternatively assigned to receive Shanzha fruit drink or placebo drink in the first 2 months or the last two months of the 5 months study period. In between the first and second treatment period, all patients will enter a Washout Period of 4 weeks and during which time patients should not receive any of the study functional fruit drink.


Eligibility criteria: Inclusion Criteria:

* • Total Cholesterol between 200-300 mg/dl (5.2-7.8 mmol/l).

  * Mean plasma triglyceride \>= 4.5 mmol/l.
  * Diastolic blood pressure 95-100 mm Hg and/or Systolic blood pressure 130-150 mm Hg.
  * Be able to give written informed consent prior to study start and comply with study requirements.

Exclusion Criteria:

* • Total Cholesterol between 200-300 mg/dl (5.2-7.8 mmol/l).

  * Mean plasma triglyceride \< 4.5 mmol/l.
  * Diastolic blood pressure 95-100 mm Hg and/or Systolic blood pressure 130-150 mm Hg.
  * Be able to give written informed consent prior to study start and comply with study requirements.

Primary outcomes:
measure: To evaluate the hypolipidemic effect of Shanzha Fruit drink in patients with hyperlipidemia
timeFrame: 5 months.
measure: To evaluate the safety of Shanzha Fruit drink in patients with hyperlipidemia by monitoring of liver function tests.
timeFrame: 5 months.
Secondary outcomes:
measure: To evaluate the hypotensive effect of Shanzha Fruit Drink
timeFrame: 5 months.
measure: To evaluate the safety of Shanzha Fruit drink in patients with hyperlipidemia by recording any adverse events reported by the study subjects or noted by the investigator.
timeFrame: 5 months.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT01553578: Healing Touch or Guided Imagery In Treating Pain, Fatigue, Nausea, and Anxiety in Patients Undergoing Chemotherapy
Official title: The Efficacy of Healing Touch Versus Guided Imagery on Pain, Fatigue, Nausea, and Anxiety in Patients' Receiving Outpatient Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorder
Fatigue
Malignant Neoplasm
Nausea and Vomiting
Pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-03-14
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized clinical trial studies healing touch or guided imagery in treating pain, fatigue, nausea, and anxiety in patients undergoing chemotherapy. Healing touch and guided imagery may help treat complications caused by chemotherapy. It is not yet known whether healing touch or guided imagery is more effective in treating pain, fatigue, nausea, and anxiety in patients undergoing chemotherapy

Detailed description: PRIMARY OBJECTIVES:

I. To determine if the provision of healing touch or guided imagery during outpatient chemotherapy is associated with decreased pain, fatigue, nausea and anxiety when compared to standard outpatient treatment protocols.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM A: Patients receive 30 minutes of healing touch therapy comprising magnetic clearing, pain drains, hands in motion/hands still and mind clearing.

ARM B: Patients listen to guided imagery audiotapes for 30 minutes

ARM C: Patients receive standard of care.

Eligibility criteria: Inclusion Criteria:

* Adult patients at the outpatient chemotherapy area will be enrolled without consideration for type of cancer or chemotherapeutic agents to be used

Primary outcomes:
measure: Change scores for each patient on pain scale
timeFrame: Approximately 6 months
measure: Change scores for each patient on fatigue scale
timeFrame: Approximately 6 months
measure: Change scores for each patient on nausea scale
timeFrame: Approximately 6 months
measure: Change scores for each patient on anxiety scale
timeFrame: Approximately 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Lisa Hodges
role: PRINCIPAL_INVESTIGATOR
References: