louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05843682: Technological Innovation in the Virtual Assistance of Patients With Uncontrolled Arterial Hypertension - Hyper 2
Official title: Technological Innovation in the Virtual Assistance of Patients With Uncontrolled Arterial Hypertension - Hyper 2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Essential Hypertension
Metabolic Cardiovascular Syndrome
Heart Disease Risk Factors
Keywords: Remote telemonitoring
Uncontrolled hypertension
Artificial intelligent
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: InCor Heart Institute
First posted: 2023-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the effectiveness of the use of artificial intelligence in home monitoring in patients with uncontrolled arterial hypertension.

Detailed description: Arterial hypertension (AH) is one of the most important cardiovascular risk factors, accounting for 13.5% of all deaths worldwide. Mobile health technologies have been applied as an important tool to improve patient engagement and blood pressure (BP) control, as an alternative approach to remote monitoring of hypertensive patients. Therefore, it is essential to help patients adopt healthy measures to assist in the daily control of BP.

As the barriers to therapeutic adherence are complex and varied, solutions to improve adherence at the population level should be multifactorial. Therefore, the use of an application elaborated by artificial intelligence adapted to individual needs and customs, can help in improving therapeutic adherence and provide better bp control in patients with uncontrolled hypertension.

Eligibility criteria: Inclusion criteria:

1. Primary arterial hypertension in drug treatment with at least 3 classes of antihypertensive drugs in optimized dose
2. Aged between 20 and 65 years
3. Blood pressure of the office ≥ 140 and/or 90 mmHg
4. Facilities to use mobile and apps

Exclusion criteria:

1. Stroke sequelae
2. Cognitive dysfunction

Primary outcomes:
measure: Blood pressure control
timeFrame: One year
measure: Glycemic control
timeFrame: One year
measure: Change of out-of-hospital visits
timeFrame: One year
Secondary outcomes:
measure: Patient engagement in treatment
timeFrame: One year
measure: Improvement in lifestyle
timeFrame: One year
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute (InCor), Hospital das Clinicas do HCFMUSP
Study officials:
affiliation: Heart Institute
name: Fábio B Jatene, MD, PHD
role: STUDY_DIRECTOR
References:
citation: Dupont J, Dupont JC, Milon H, Froment A. [Spontaneous mortality and vascular lesions in 3 rat strains with different blood pressure levels]. C R Acad Hebd Seances Acad Sci D. 1975 Apr 7;280(13):1637-40. French.
Clinical trial NCT00574782: Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE)
Official title: Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Coronary Heart Disease
Peripheral Vascular Disease
CVA
Diabetes
Keywords: cholesterol, coronary heart disease
rosuvastatin
LDL-C goal
hypercholesterolemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-12-17
Enrollment: 2660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: In an observational multi-centre study (CHALLENGE), the effects were assessed of starting treatment with low doses of rosuvastatin in statin naive patients with a history of coronary heart disease (CHD), peripheral vascular disease (PVD), cerebrovascular accident (CVA), transient ischemic attack (TIA) or diabetes (DM), on low-density lipoprotein cholesterol (LDL-C) goal achievement. Also proportional changes in LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), triglycerides (TG) and the ratio TC/HDL-C were studied.


Eligibility criteria: Inclusion Criteria:

* Patients eligible for the study were high-risk patients with a documented history of CHD, PVD, cerebrovascular atherosclerotic disease, DM II or DM I with microalbuminuria. LDL-C had to be \> 2.5 mmol/l and the patient did not use any cholesterol lowering medication during the last 3 months preceding inclusion. The specialist made the decision to start treatment with rosuvastatin irrespective of study participation. Patient approved to place anonymous results at the disposal of AstraZeneca

Exclusion Criteria:

* Exclusion criteria included patients familiar with muscular pain, myopathy or liver function disorders (inclusive elevation of serum transaminases), patients with familial dyslipideamia like familial hypercholesterolaemia and familial combined hyperlipid

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CV
name: Ingrid van Geel
role: STUDY_CHAIR
affiliation: CV
name: Ingeborg Vosjan
role: STUDY_CHAIR
References:
Clinical trial NCT05594082: Real-world Effectiveness and Safety Study of T-Dxd in Chinese Metastatic Breast Cancer
Official title: Real-world Effectiveness and Safety Study of T-Dxd in Chinese Metastatic Breast Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese metastatic breast cancer patients

Brief summary: The aim of this trial is to explore the real-world effectiveness and poteintial predictors in Chinese metastatic breast cancer patients.


Eligibility criteria: Inclusion Criteria:

1. Patients aged over 18 years old.
2. Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
3. Plan to receive or has received Trastuzumab Deruxtecan monotherapy
4. Available medical history.

Exclusion Criteria:

1. Incomplete medical history.
2. Pregnancy or breast-breeding

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
Secondary outcomes:
measure: ORR
timeFrame: 6 weeks
measure: CBR
timeFrame: 6 weeks
measure: OS
timeFrame: 6 weeks
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT01138982: Effectiveness Study of a Swedish Youth Mentoring Program
Official title: A Randomized Effectiveness Trial of a One-to-one, Adult-to-youth Mentoring Program in Sweden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Keywords: Youth mentoring
Effectiveness
Sweden
low-risk youth
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Social Affairs, Sweden
name: Region Stockholm
First posted: 2010-06-08
Enrollment: 128
Sex: ALL
Minimum age (years): 14
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to investigate the effectiveness of a one-to-one, adult-to-youth primary preventive mentoring program in Sweden. Outcome domains and criteria for inclusion and exclusion of study participants are elaborated in collaboration with the providing NGO, and the program is given as customary.


Eligibility criteria: Inclusion Criteria:

* a self-reported need of the youth for additional adult contacts

Exclusion Criteria:

* current or past regular use of illicit drugs
* repeated delinquent behaviour or single acts of violence against persons
* ongoing contacts with psychiatric care or social services

Primary outcomes:
measure: Self-reported substance use
timeFrame: One year
Secondary outcomes:
measure: Youth delinquency
timeFrame: One year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Mentor Sweden
Study officials:
affiliation: Centre for Psychiatry Research Stockholm, Karolinska Institutet/Stockholm County Council Health Care Provision
name: Maria C Bodin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00348582: Acular LS vs. Nevanac in Post op Inflammation Following Cataract Surgery
Official title: Acular LS vs. Nevanac in Post op Inflammation Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2006-07-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare the clinical outcomes, safety and efficacy in patients randomized to receive either ketorolac or nepafanac following cataract surgery.


Eligibility criteria: Inclusion Criteria:

* · Male or female \> 18 years of age scheduled to undergo cataract surgery

  * Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)
  * Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

* · Known contraindication to any study medication or any of their components

  * Uncontrolled systemic disease
  * Required use of ocular medications other than the study medications during the study
  * Abnormal pre-operative OCTs if obtainable
  * Diabetic patients
  * Use of oral NSAIDS
  * Patients with ocular disease (macula degeneration, glaucoma, corneal disease) which reduces the potential visual rehabilitation (patients will ocular disease that will no preclude achievement of a 20/20 visual outcome may be included)..

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Dr. Francis
state: Pennsylvania
Study officials:
affiliation: University Pittsburgh Medical Center Eye and Ear Institute
name: Francis Mah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02607982: CCRT for Esophageal Cancer.
Official title: Long-term Results of Definitive Concurrent Chemoradiotherapy Using Paclitaxel Plus Oxaliplatin in Unresectable Locally Advanced Esophageal Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Concurrent Chemoradiotherapy
Oxaliplatin
Paclitaxel
Keywords: Esophageal cancer
Concurrent chemoradiotherapy
Oxaliplatin
Paclitaxel
Survival
Toxicity
Lead sponsor: Hangzhou Cancer Hospital
Sponsor class: OTHER
First posted: 2015-11-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed at assessing the efficiency and safety of concurrent chemoradiotherapy (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced esophageal cancer patients.


Eligibility criteria: Inclusion Criteria:

1. Cytologically or histologically confirmed esophageal carcinoma
2. Age of 20 -80
3. ECOG performance status: 0-1;
4. No treatments prior to enrollment;
5. At least one measurable lesion on CT, MRI or esophageal barium exam;
6. Normal functions of heart, lung, liver, kidney and bone marrow
7. Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
8. Informed consent signed

Exclusion Criteria:

1. Prior treatments of chemotherapy or irradiation;
2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
4. Participating in other clinical trials;
5. Pregnancy, breast feeding, or not adopting birth control;
6. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
7. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;

Primary outcomes:
measure: response rate
timeFrame: week 4
Secondary outcomes:
measure: Survival outcome
timeFrame: year 0- year 5
measure: Toxicity
timeFrame: year 0- year 5
Other outcomes:
Locations:
Study officials:
References:
citation: Zhang P, Xie CY, Wu SX. [Concurrent chemoradiation with paclitaxel and platinum for locally advanced esophageal cancer]. Zhonghua Zhong Liu Za Zhi. 2007 Oct;29(10):773-7. Chinese.
Clinical trial NCT01055782: Colonoscopy Endoguide in Specialist Practice
Official title: Kan Anvendelse af Endoskopisk Positioneringsudstyr Ved coloskopiundersøgelsen (kikkertundersøgelse af Tarmen) i en højt Specialiseret Praksis Forbedre Patientens Subjektive Kvalitetsoplevelse (Smerteperception)?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Pain
Keywords: Colonoscopy
Endoguide
Pain perception
Colonoscopy to the coecum (success rate)
Patient's perception of pain
Duration of successful colonoscopies
Lead sponsor: The Specialist Doctors at Rolighedsvej
Sponsor class: OTHER
Collaborators: name: Danish Medical Association
name: Surgical Clinic, Allerød, Denmark
First posted: 2010-01-26
Enrollment: 1004
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study includes 700 patients referred for colonoscopy are randomized to colonoscopy with or without endoguide.

The study will investigate whether the endoguide improves success rate and the patient's perception of pain.


Eligibility criteria: Inclusion Criteria:

* Informed consent provided

Exclusion Criteria:

* Informed consent not provided or not possible to obtain

Primary outcomes:
measure: Completed Colonoscopy
timeFrame: immediately after colonoscopy
Secondary outcomes:
measure: Perception of Pain
timeFrame: After endoscopy (within 10mins) and 1 day after endoscopy
Other outcomes:
Locations:
city: Birkerød
country: Denmark
facility: Speciallægerne på Rolighedsvej
Study officials:
References:
citation: Bak-Christensen A, Knudsen E, Hendel J, Ifaoui IB, Lehrskov-Schmidt L, Hendel L. Colonoscopy results are not enhanced by use of magnet endoguide in specialist practice. Dan Med J. 2013 Jun;60(6):A4611.
Clinical trial NCT01242982: Subcapital and Shaft Fractures of the 5. Metacarpal
Official title: Prospective Randomised Study of Subcapital and Shaft Fractures of the 5. Metacarpal. Comparison Conservative Treatment and Operation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fracture
Keywords: 5. metacarpal fracture/fractures
subcapital
shaft
closed
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2010-11-17
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out the best treatment for subcapital and shaft fractures of the 5. metacarpal.

It is a prospective randomized multicenter study. Comparing only fractures dislocated more than 30 degrees.

One group will be operated with intramedullary pins and one group will be treated conservatively with reduction and then Plaster of Paris for 3 weeks.

All patients will be followed up after 3, 6 and 12 months.

Detailed description: See above

Eligibility criteria: Inclusion Criteria:

* voluntarily, only isolated subcapital og shaft fracture of the 5. metacarpal,operated/reduction within 10 days of injury,not intoxicated,degree of fracture dislocation minimum 30 degrees measured on the X-ray.

Exclusion Criteria:

* open fractures, fractures of the head of 5. metacarpal/intraarticular fractures, patients who wants to be followed up at Hospitals outside the study area, earlier injury of the hand that might have influence on function.

Primary outcomes:
measure: Clinical outcome comparing conservative and operative treatment of subcapital and shaft fractures of the 5. metacarpal
timeFrame: 2 -3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kristiansund-N
country: Norway
facility: Kristiansund sykehus, Helse Nord Møre og Romsdal
state: Møre og Romsdal
city: Molde
country: Norway
facility: Molde sykehus, Helse Nordmøre og Romsdal
state: Møre og Romsdal
city: Ålesund
country: Norway
facility: Ålesund sjukehus, Helse Sunmøre
state: Møre og Romsdal
city: Namsos
country: Norway
facility: Sykehuset Namsos, Helse Nord-Trøndelag
state: Nord -Trøndelag
city: Tønsberg
country: Norway
facility: Sykehuset i Vestfold-Tønsberg
Study officials:
affiliation: St. Olavs Hospital, orthopedic department
name: Ivar Rossvoll, dr. med.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01848782: Impact of Adding a Limitation Section in Abstract of Systematic Review
Official title: Impact of Adding a Limitation Section in Abstract of Systematic Review on Interpretation by Readers: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systematic Review
Keywords: abstract
meta-analysis
systematic review
interpretation
results
quality
bias
spin
limits
limitation
risk of bias
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Objective: The investigators aim to evaluate the impact of a adding a " limitations " section in systematic review's abstract on result's interpretation by readers Design: randomized controlled trial with two parallel arms. Participants will be invited to participate in an online survey.

Participants: Eligible participants are corresponding authors of clinical trials published between 2010 and 2012 and referenced in Medline.

Intervention: The investigators will evaluate the impact of the presence of a " limitations " section in abstract of systematic review with meta- analysis. The investigators selected abstracts of meta-analysis from a sample.

Selected abstract will be standardised and the treatment's name hidden. Two groups of abstract will be presented as follow: 1) abstract without " limitations " section 2) abstract with " limitations " section. The " limitations " section will be written by authors and will briefly describe the risk of bias of included studies.

Selected participant are invited by e-mail to answer the survey. After reading one abstract from his/her group of randomisation they are invited to answer 5 questions about their interpretation of the results.


Eligibility criteria: Inclusion Criteria:

* corresponding authors of clinical trail indexed in pubmed with email address available

Primary outcomes:
measure: Confidence in the Results of the Systematic Review
timeFrame: 1 month
Secondary outcomes:
measure: Confidence With the Validity of the Conclusions
timeFrame: 1 month
measure: Beneficial Effect of the Experimental Intervention
timeFrame: 1 month
measure: Influence of Results on Clinical Practice
timeFrame: 1 month
measure: The Rigor of the Systematic Review
timeFrame: 1 month
Other outcomes:
Locations:
city: Paris
country: France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Amelie YAVCHITZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yavchitz A, Ravaud P, Hopewell S, Baron G, Boutron I. Impact of adding a limitations section to abstracts of systematic reviews on readers' interpretation: a randomized controlled trial. BMC Med Res Methodol. 2014 Nov 24;14:123. doi: 10.1186/1471-2288-14-123.
Clinical trial NCT06322082: Pilates Training and Low Intensity Shock Wave Therapy for Post-prostatectomy Stress Incontinence
Official title: Pilates Training Combined With Low Intensity Shock Wave Therapy on Post-prostatectomy Stress Incontinence: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stress Incontinence, Male
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2024-03-20
Enrollment: 120
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 120 Patients with urinary incontinence following radical prostatectomy would be randomly assigned to either 4 groups all receive conventional pelvic floor muscle exercises plus group A receive Pilates exercises and Low Intensity Extracorporeal Shock Wave Therapy, group B receive Low Intensity Extracorporeal Shock Wave Therapy, group C receive Pilates exercises and group D receive conventional pelvic floor muscle exercises. Assessment at baseline, immediately after the intervention, to evaluate the degree of urinary incontinence and quality of life after three months from treatment.

Detailed description: 120 Patients with urinary incontinence following radical prostatectomy would be randomly assigned to either 4 groups all receive conventional pelvic floor muscle exercises plus group A receive Pilates exercises and Low Intensity Extracorporeal Shock Wave Therapy, group B receive Low Intensity Extracorporeal Shock Wave Therapy, group C receive Pilates exercises and group D receive conventional pelvic floor muscle exercises. Assessment at baseline, immediately after the intervention, to evaluate the degree of urinary incontinence by Urodynamic investigation system, Severity index scale and Cytometry and quality of life by The quality of life questionnaire IQOL after three months from treatment.

Eligibility criteria: Inclusion Criteria:

* All patients diagnosed as urinary incontinence.
* Age between 40 -75 male patients or older.
* All patients received the same medical treatment

Exclusion Criteria:

* adjuvant or neoadjuvant chemo-radiation therapy.
* severe postoperative complications.
* history of pelvic surgery, and diseases that could affect voiding function and limitations for the exercise program such as for patients with serious cardiovascular events or spinal or articular disease.

Primary outcomes:
measure: Cystometry
timeFrame: before treatment and after 3 months
measure: Severity index scale
timeFrame: before treatment and after 3 months
Secondary outcomes:
measure: body mass index
timeFrame: before treatment and after 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of physical therapy , Cairo university
Study officials:
affiliation: Professor at Faculty of physical therapy, Cairo University
name: Marwa Eid
role: PRINCIPAL_INVESTIGATOR
References: