louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03365349: Two Narrative Medicine Interventions in Type 1 Diabetes
Official title: Comparison Between Two Narrative Medicine Approaches in Type 1 Diabetes (T1D): a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 87
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: a randomized prospective study aims at comparing the impact of a "living theater" session with a simple "writing workshop " on emotional distress (Problem Areas in Diabetes Questionnaire PAID) and illness perception ( Illness Perception Questionnaire IPQR) during a 5 day education course

Detailed description: This randomized prospective pilot study aims at comparing the impact of a "living theater" session with a simple "writing workshop " on emotional distress (Problem Areas in Diabetes Questionnaire PAID) and illness perception ( Illness Perception Questionnaire IPQR) during a 5 day education course on Functional Insulin Therapy (FIT). Questionaries at T0 (course day 1 ) and T1 (3 months later). qualitative interviews in a sub group of patients random G1 and G2 subgroup at T1, with a general inductive approach to capture all representations

Eligibility criteria: Inclusion Criteria:

* type 1 diabetes

Exclusion Criteria:

* no french language

Primary outcomes:
measure: Change from baseline IPQR (Illness Perception Questionnaire) score at 3 months
timeFrame: 3 months after intervention
Secondary outcomes:
measure: comparison of the two groups concerning answers to qualitative interviews at T 3 months after the intervention
timeFrame: 3 months after intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02959749: Osimertinib or Docetaxel-bevacizumab as Third-line Treatment in EGFR T790M Mutated Non-Small Cell Lung Cancer
Official title: Phase III Study of Osimertinib or Docetaxel-bevacizumab as Third-line Treatment in EGFR T790M Mutated Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Progression Free Survival
Keywords: Osimertinib
EGFR T790M Resistant Mutation
Docetaxel
Bevacizumab
Non Small Cell Lung
Lead sponsor: Qingdao Central Hospital
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acquired epidermal growth factor receptor (EGFR) T790M mutation is the most common genetic change after resistant to first generation EGFR tyrosine kinase inhibitor (EGFR TKI) in non-small cell lung cancer. After a 10 to 14 months median progression-free survival with the treatment of first generation EGFR TKI, half of patients will get disease progression.For patients progression after treated with first line EGFR TKI and second line double bullets chemotherapy or chemotherapy then EGFR TKI, optimal third line therapy is quite critical important for benefit patients' survival. We conducted this study was aimed to compare the efficacy and toxicity between osimertinib and docetaxel-bevacizumab as the third line therapy in patients with local advanced or metastatic non-squamous cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* local advanced or metastatic non-small cell lung cancer
* large cell lung carcinoma or adenocinoma
* Previously treated by TKI-Chemotherapy or Chemotherapy-TKI
* EGFR T790M positive
* No uncontrolled hypertension
* No active bleeding or thrombosis in recent 6 months
* No previously treated with VEGF antibody

Exclusion Criteria:

* newly diagnosed thrombosis
* anti-coagulation therapy
* uncontrolled hypertension
* uncontrolled nephropathy

Primary outcomes:
measure: progression free survival
timeFrame: Average 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Qingdao Central Hospital, Qingdao Cancer Hospital
state: Shandong
Study officials:
References:
citation: Nie K, Zhang Z, Zhang C, Geng C, Zhang L, Xu X, Liu S, Wang S, Zhuang X, Lan K, Ji Y. Osimertinib compared docetaxel-bevacizumab as third-line treatment in EGFR T790M mutated non-small-cell lung cancer. Lung Cancer. 2018 Jul;121:5-11. doi: 10.1016/j.lungcan.2018.04.012. Epub 2018 Apr 17.
Clinical trial NCT01247649: Assessing Continuous Non- Invasive Blood Glucose Sensor- Physical Logic AG
Official title: Assessing Continuous Non- Invasive Blood Glucose Sensor- Physical Logic AG
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Continuous glucose monitoring system
Non invasive
Type 1 diabetes
Dielectric spectroscopy
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2010-11-24
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The present study is aimed to evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation.

Detailed description: The non invasive continuous glucose sensing system of Physical Logic is based on a vector network analyzer (VNA), which monitor blood glucose through propriety sensors.Dielectric spectroscopy is an analytical technique whereby the electromagnetic radiation is affected by the electric dipole moment of the sample it interacts with. This method utilizes the change in the impedance of the antenna to measure the change in the relaxation processes of the interrogated medium.

The VNA (vector network analyzer) , which emits non irradiating electromagnetic waves in very low power emission, is connected via standard coaxial cables to propriety sensors that are attached to the patient skin without direct contact.

Study objective:

To evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation.The glucose values generated by the investigational non invasive devise will be compared to glucose reading of a reference devise, which measure blood glucose levels at the subcutaneous tissue.

During the study we will evaluate the reliability of the study device under the conditions of alter blood glucose values in the range of 50-400 mg/dl:

Eligibility criteria: Inclusion Criteria:

1. Signing an inform consent form
2. Type 1 diabetes diagnosed at least 12 months prior to study inclusion
3. Age \> 18 years old
4. Willing to perform all study related procedures

Exclusion Criteria:

1. Known or suspected allergy to the sensor or one of its components
2. Psychiatric disorder
3. Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease
4. Patients who are not willing or are not capable of performing the protocol requirements
5. Participating in another study that includes investigational drug or investigational equipment
6. Pregnancy

Primary outcomes:
measure: Correlation between continuous glucose measurements using study device and YSI(yellow springs instrument)
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: Schneider Children's Medical center
Study officials:
affiliation: Schenider Children's Medical
name: Revital Nimri, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01906749: Colchicine for Acute Coronary Syndromes
Official title: Colchicine for Acute Coronary Syndromes. A Multicenter Double Blind Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: Acute coronary syndrome
Colchicine
Lead sponsor: Maria Vittoria Hospital
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multicenter, double blind, randomized trial to assess the effect of low-dose colchicine (0.5mg/day) on overall mortality, new coronary syndromes, and ischemic stroke at 2 years after an acute coronary syndrome. The study hypothesis is that colchicine may reduce the specified combined endpoint from 16% to 7-8% at a 2-years follow-up.

Detailed description: Multicenter, double-blind randomized trial to evaluate the efficacy of low dose colchicine (0.5mg once daily for 2 years) to reduce the incidence of subsequent overall mortality, new acute coronary syndromes, and ischemic stroke in patients admitted for an acute coronary syndrome.

Eligibility criteria: Inclusion Criteria:

* \>18years
* Acute coronary syndrome (unstable angina or acute myocardial infarction)
* Life expectancy\> 2 years
* Absence of contraindications to colchicine

Exclusion Criteria:

* Colchicine treatment for any cause
* Severe liver disease
* Renal insufficiency with creatinine\>150mmol/l or creatinine clearance\<30ml/min/1.73m2
* Known cancer
* Chronic inflammatory bowel disease
* treatment with cyclosporine
* allergy or hypersensitivity to colchicine
* pregnancy or lactating woman or woman with childbearing potential without valid contraception

Primary outcomes:
measure: Overall mortality, new acute coronary syndrome, and ischemic stroke.
timeFrame: 24 months
Secondary outcomes:
measure: Mortality
timeFrame: 24 months
measure: New acute coronary syndrome (unstable angina and myocardial infarction)
timeFrame: 24 months
measure: Ischemic Stroke
timeFrame: 24 months
Other outcomes:
Locations:
city: Rivoli
country: Italy
facility: Cardiology Dpt.
state: Torino
city: Torino
country: Italy
facility: Cardiology Dpt.Maria Vittoria Hospital
city: Torino
country: Italy
facility: Cardiology Dpt.San Giovanni Bosco Hospital
Study officials:
affiliation: Cardiology Dpt.Maria Vittoria Hospital, Torino, Italy
name: Massimo Imazio, MD
role: STUDY_CHAIR
References:
citation: Silvis MJM, Demkes EJ, Fiolet ATL, Dekker M, Bosch L, van Hout GPJ, Timmers L, de Kleijn DPV. Immunomodulation of the NLRP3 Inflammasome in Atherosclerosis, Coronary Artery Disease, and Acute Myocardial Infarction. J Cardiovasc Transl Res. 2021 Feb;14(1):23-34. doi: 10.1007/s12265-020-10049-w. Epub 2020 Jul 9.
Clinical trial NCT05350449: Loving Kindness Meditation Among Adults 50 Years and Older
Official title: Loving Kindness Meditation Among Adults 50 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 59
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test the feasibility and acceptability of loving-kindness meditation among adults 50 years and older. It will also examine the benefits of this intervention and compare the outcomes between two groups (intervention and wait-list control).

Detailed description: The main aim of the research is to assess the feasibility and acceptability of the Loving-kindness meditation intervention among adults 50 years or older. It will also examine the intervention's preliminary impact on loneliness, self-compassion, cognitive function, and psychological well-being. The study will use a randomized controlled trial with waitlist control.

Eligibility criteria: Inclusion Criteria:

• Adults 50 years or older living in Southern Nevada

Exclusion Criteria:

• Cognitive or language barrier that would make it difficult to understand and sign the informed consent

Primary outcomes:
measure: Change in Self-compassion
timeFrame: baseline, immediately post-intervention, and week 4 and week 8 post intervention.
measure: Change in Loneliness
timeFrame: baseline, immediately post-intervention, and week 4 and week 8 post intervention.
Secondary outcomes:
measure: Change in Anxiety
timeFrame: baseline, immediately post-intervention, and week 4 and week 8 post intervention.
measure: Change in Depressive Symptoms
timeFrame: baseline, immediately post-intervention, and week 4 and week 8 post intervention.
measure: Change in Cognitive Function
timeFrame: baseline, immediately post-intervention, and week 4 and week 8 post intervention.
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University of Nevada Las Vegas
state: Nevada
Study officials:
affiliation: University of Nevada, Las Vegas
name: Nirmala Lekhak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05347849: Single Ascending Dose Study With BPL-003 in Healthy Subjects
Official title: A Two-part Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Intranasal BPL-003 (5-Methoxy-N,N-dimethyltryptamine Benzoate) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics in Healthy Adults
Lead sponsor: Beckley Psytech Limited
Sponsor class: INDUSTRY
First posted: 2022-04-26
Enrollment: 62
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The study will evaluate safety, tolerability and PK profile of BPL-003 in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Medically healthy based on medical records and study specific assessments

Exclusion Criteria:

* Presence or history of severe adverse reaction to any drug or drug excipient

Primary outcomes:
measure: Percentage of subjects with treatment emergent AEs (TEAES)
timeFrame: From screening through to the follow up visit, up to 65 days
Secondary outcomes:
measure: Peak plasma concentration (Cmax)
timeFrame: Day 1 (dosing day) and Day 2
measure: Time to reach Cmax (tmax)
timeFrame: Day 1 (dosing day) and Day 2
measure: Area under the plasma concentration- time curve
timeFrame: Day 1 (dosing day) and Day 2
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research
Study officials:
affiliation: Beckley Psytech Ltd
name: VP & Head of Clinical Development, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05056649: The Role of the GP in the Management of Ambulatory Heart Failure
Official title: The Role of the GP in the Management of Ambulatory Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients with impaired ejection fraction (LVEF \< 40%), under 85 years of age, admitted to the emergency department for cardiac decompensation and hospitalised in the aftermath of this decompensation, for whom the sum of the doses of ACE inhibitor or ARB2 + BB + aldosterone antagonist is less than 50% of the dose required for this patient

Brief summary: To describe the causes mentioned by general practitioners, explaining the under-treatment of the three main treatments for heart failure with impaired ejection fraction (ARS blockers of the type ACEinhibitor/ARA2/ARNi, ß- and/or anti-aldosterone).


Eligibility criteria: Inclusion Criteria:

* Patients with a previous diagnosis of heart failure with impaired ejection fraction (LVEF \< 40%)
* Under 85 years of age
* Admitted to an Emergency department for cardiac decompensation
* Hospitalized following this decompensation
* Not deceased within one month of hospitalisation
* Whose sum of the doses of ACEI or ARB2 + BB + aldosterone antagonist is less than 50% of the dose required for this patient\* (definition in annex)
* Who did not object within one month of being informed

Exclusion Criteria:- Patient objecting to the use of their data

* Patient who is a minor
* Patient who does not have a general practitioner

Primary outcomes:
measure: Quantitative analysis of verbatims after grouping
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU of Nancy
Study officials:
References:
Clinical trial NCT05317949: Effect of Integrated Neuromuscular Training on Medium Fast Bowler in Cricket
Official title: Effect of Integrated Neuromuscular Training on Explosive Strength, Speed and Endurance of Medium Fast Bowler in Cricket
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Physical Therapy
Keywords: Sports Rehabilitation
Integrated Neuromuscular Training
Speed
Endurance
Explosive strength
Fast bowler
Cricket
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 28
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of Integrated Neuromuscular Training on Explosive Strength, Speed and Endurance of Medium Fast Bowler in Cricket

Detailed description: Integrated neuromuscular training (INT) is a combination of functional movement training and speciﬁc strength, balance, speed, sensitivity, and isometric training, which aims to evaluate and prevent sports injury and improve sports performance. Neuromuscular control defects are mainly manifested as decreases in muscle strength, explosive power, or abnormal activation patterns. INT is deﬁned as a conceptual training program that incorporates general (e.g., fundamental movements) and speciﬁc strength and conditioning tasks (e.g., resistance, balance, agility, plyometric) to improve injury resilience and to enhance sporting and motor skill performance. The majority of studies in youth examining neuromuscular training strategies to improve performance and injury prevention include multiple components (for example, balance, strength, plyometric, agility, speed, coordination. INT sessions are characterized by short bursts of physical activity interspersed with brief rest periods.

the purpose of this study is to find the effect of integrated neuromuscular training on explosive strength, speed and endurance of medium fast bowler in cricket

Eligibility criteria: Inclusion Criteria:

* Medium fast bowlers
* Players playing cricket for \> 1 year
* Players engaging in cricket ≥ 3 days in a week

Exclusion Criteria:

* History of any injury in past 6 months.
* Those players having musculoskeletal, neurological, cardiorespiratory problems
* Those players who have any medical condition

Primary outcomes:
measure: Soft Ball Throw Test
timeFrame: Eight weeks
measure: 50 Yard Dash
timeFrame: Eight weeks
measure: 1 Mile Run Test
timeFrame: Eight weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Sports Complex
state: KPK
Study officials:
affiliation: Riphah International University
name: Aadil Omer, Ph.D*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06928649: Stratifying Critically Ill Patients for Novel Ferroptosis or Pyroptosis Intervention Strategies
Official title: Innovative Cell Death Diagnostics Allowing Stratifying Critically Ill Patients for Novel Ferroptosis or Pyroptosis Intervention Strategies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Trauma Related Injuries
Subarachnoid Haemorrhage (SAH)
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2025-04-15
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In order to better determine which therapy is best for patiënts which present with organ falure during the course of their stay in the intesive care unit (ICU) , one has to determine which underlying mechanism is causing this organ falure. We will determine levels of so called "biomarkers" for ferroptosis (a mechan ism of iron-related cell death) in the peripheral blood and biological fluids of criticaly ill patients admitted to the ICU with a catastrrophy (severe infection, trauma ...) . Why ? If it turns out that this ferroptosis plays a role in the ocurrence of organ failure in the critially ill, this will lead to new therapies in the future as drugs become more and more available which can influene this biochemical "pahway". of iron-relatd death.


Eligibility criteria: Inclusion Criteria:

* Admitted to the ICU of UZA
* Critically ill and predicted to be hospitalised in the ICU for \> 48 hours (i.e. mostly patients admitted for sepsis, trauma, haemorrhagic shock, neurological catastrophe ... which means at risk to develop mono-or multiple organ failure)
* With arterial line in place (for blood sampling)

Exclusion Criteria:

* Refusal of consent by patient or closest relative
* Postoperative patients after major surgery in whom prolonged ICU stay is not foreseen (i.e. elective cardiac surgery

Primary outcomes:
measure: Number of patients with survival after 28 days.
timeFrame: 28 days
Secondary outcomes:
measure: Change from baseline concentration of Norepinephrine every day during ICU stay
timeFrame: 28 days
measure: Change in SOFA score during ICU stay
timeFrame: Change from enrollment to 14 days of ICU stay
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Philippe Jorens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01367249: Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery
Official title: Efficacy and Safety of Bromfenac Ophthalmic Solution vs. Placebo for the Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Inflammation
Cataract
Keywords: cataract surgery
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 440
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: This is an efficacy study of Bromfenac Ophthalmic Solution in cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Male or female at least 18 years of age who are scheduled for unilateral cataract surgery

Exclusion Criteria:

* Have known hypersensitivity to bromfenac or to any component of the investigational product

Primary outcomes:
measure: Ocular Inflammation
timeFrame: Day 15
Secondary outcomes:
measure: Ocular Pain
timeFrame: Day 1
Other outcomes:
Locations:
city: Irvine
country: United States
facility: ISTA Pharmaceuticals, Inc.
state: California
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Tim McNamara, PharmD
role: STUDY_DIRECTOR
References: