louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01523873: Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)
Official title: Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Safety Profile of DOTAREM
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2012-02-01
Enrollment: 35921
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients scheduled for a Dotarem®-enhanced MRI over a one year period at each participating radiological site

Brief summary: The main purpose of this study is to prospectively assess the general safety profile of Dotarem


Eligibility criteria: Inclusion Criteria:

* patient scheduled for a Dotarem®-enhanced MRI

Exclusion Criteria:

* patient with a contra-indication to MR examination
* patient with a contra-indication to Dotarem® injection as per local SPC

Primary outcomes:
measure: Frequency of Adverse Events
timeFrame: During the time of usual follow-up post Dotarem administration (from less than 30 min to 1 hour after magnetic resonance examination).
Secondary outcomes:
measure: Nephrogenic Systemic Fibrosis Incidence
timeFrame: Follow-up of at least 3 months after magnetic resonance examination
measure: Image Quality
timeFrame: Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)
measure: Diagnostic Quality
timeFrame: Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Vienna
country: Austria
facility: Diagnosticum Gersthof
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Paris
country: France
facility: Hôpital Necker
city: Cologne
country: Germany
facility: Universitätskliniken
city: Mumbai
country: India
facility: Bombay Hospital Institute of Medical Sciences
city: Verona
country: Italy
facility: Ospedale Policlinico Giambattista Rossi
city: Tabouk
country: Saudi Arabia
facility: Tabouk Military Hospital
city: Lugo
country: Spain
facility: Complexo Hospitalario Xeral-Calde
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
Study officials:
References:
citation: Heshmatzadeh Behzadi A, McDonald J. Gadolinium-based contrast agents for imaging of the central nervous system: A multicenter European prospective study. Medicine (Baltimore). 2022 Aug 26;101(34):e30163. doi: 10.1097/MD.0000000000030163.
Clinical trial NCT05391373: Effect of Laughter Therapy on Perceived Stress and Quality of Life
Official title: Effect of Laughter Therapy on Perceived Stress and Quality of Life in Women With Breast Cancer: An Assessor-blinded, Parallel Group, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laughter Therapy
Keywords: Perceived stress
Quality of life
Laughter therapy
Breast cancer
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Breast cancer is the most common type of cancer seen in women worldwide and ranks first. Chemotherapy is one of the commonly used methods of treatment in breast cancer. Physiological and psychological symptoms that occur due to chemotherapy treatment affect women negatively and reduce their quality of life. For this reason, there is a need for an intervention that could decrease psychological symptoms such as stress and improve quality of life in women with breast cancer. In the literature, it is stated that laughter therapy which is one of the non-pharmacological methods, can be an effective nursing intervention to decrease stress and improve the quality of life in women with breast cancer.

Detailed description: This an assessor-blinded, parallel group randomized controlled trial aimed that investigating the effect of laughter therapy on perceived stress and quality of life in women with breast cancer.This trial was conducted in the chemotherapy outpatient clinic of training and research hospital located in Turkey. All patients were women with breast cancer who received a once-weekly Paclitaxel regimen.

Eligibility criteria: Inclusion Criteria:

* 18 years and older women,
* Stages II or III breast cancer
* Receiving Pacitaxel chemotherapy regimen per a week

Exclusion Criteria:

* Using any complementary and alternative (CAM) treatment method during practice
* Having psychological diseases

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: The scale was filled in the baseline (before the beginning of the Laughter therapy), 5th and 9th weeks.
Secondary outcomes:
measure: Quality of Life Scale (SF-12)
timeFrame: The scale was filled in the baseline (before the beginning of the Laughter therapy), 5th and 9th weeks.
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Bakircay University Health Sciences Faculty
Study officials:
References:
Clinical trial NCT06770673: Together Overcoming Diabetes - Great Plains
Official title: Culturally Grounded Diabetes Intervention With Lakota Populations in South Dakota
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: The NIH Community Engagement Alliance
name: Oyate Health Center
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-01-13
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Waitlist randomized control trial
Primary purpose: PREVENTION

Brief summary: The goal of this research is to evaluate a scientifically rigorous diabetes intervention, Together Overcoming Diabetes (TOD), that has been tailored to address the unique underlying risk and protective factors and social determinants of diabetes among American Indian/Alaska Native (AI/AN) populations.


Eligibility criteria: Inclusion Criteria - Adult Index Participants:

* 18 years and older
* Self-identifies as American Indian or Alaska Native
* Rapid City-based participants who reside within 1 hour transportation range of the Oyate Health Center
* Verification from a health provider to confirm Type 2 Diabetes diagnosis by laboratory test.
* Caregiver to a 10- to 25-year-old in their home at the time of screening.
* Willing to complete all implementation and follow-up assessments.
* Willing to be randomized for the intervention.

Exclusion Criteria - Adult Index Participants:

* Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
* Willing to serve as 'support person' for the adult participant.
* Has a circumstance that might impact successful participation based on provider judgment considering instances where diabetes control can become more difficult with advanced disease or special conditions including: pregnant, nursing, or planning to become pregnant, end-stage renal disease on dialysis, diabetes due to secondary causes such as Cushing's or Cystic Fibrosis, or any condition that may inhibit participation

Inclusion Criteria - Youth Support Participants:

* Between 10 years and 25 years old
* Self-identifies as American Indian or Alaska Native.
* Willing to serve as 'support person' for the adult participant.
* Willing to complete all implementation and follow-up assessments.
* Willing to be randomized for the intervention.

Exclusion Criteria - Youth Support Participants:

* Cognitively or visually impaired
* Youth in foster care (due to potential mobility of foster youth).

Primary outcomes:
measure: Glycated hemoglobin (HbA1c)
timeFrame: Baseline, 2 months, 4 months, and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rapid City
country: United States
facility: Center for Indigenous Health - Great Plains Hub
state: South Dakota
Study officials:
affiliation: Johns Hopkins University
name: Donald Warne, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05477173: Psychiatric Disorders Related to Diabetes Mellitus Type 1 Among Children in Egypt
Official title: Psychiatric Disorders Related to Children With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus Type 1
Adolescents
Psychiatric Disorders
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 140
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: children with Diabetes Mellitus Type 1

Brief summary: Type 1 diabetes is the most common endocrine disorder in children and adolescents. It is characterised by a deficiency in insulin synthesis and requires daily insulin injections to manage glucose levels. Therefore, there are numerous medical approaches to its therapy, such as levels of glycosylated haemoglobin (HbA1c) as a marker of glycaemic control during the last 3 months and monitoring of blood glucose levels, influencing the mental health and the quality of life of the patient and family. Hens, the importance of the psychological adjustment to children and adolescents with type 1 diabetes besides insulin injection, adequate diet and regular exercise rises, in order to maintain stable psychological status and functional mental health, and prevent psychological disorders such as anxiety, depression and sleep disorders. Approaching the comorbidity in these children and adolescents starts with the diagnosis and with the health changes in all aspects.


Eligibility criteria: Inclusion Criteria:

1. Both boys and girls aged 6-12 years.
2. Willing of the parents or the caregivers to participate in the study.
3. Duration of type 1 DM of at least 1 year.

Exclusion Criteria:

1. Children with intelligence quotient below 70.
2. Children with history of substance use.
3. Children with another medical or neurological conditions.

Primary outcomes:
measure: Measure frequency of sleep problems with diabetes mellitus type 1
timeFrame: through study completion, an average of 1 year
measure: Measures frequency of psychiatric problems with diabetes mellitus type 1
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06267573: Thoracoabdominal Aortic Aneurysms
Official title: Outcomes of Endovascular Repair of Thoracoabdominal Aortic Aneurysms
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Thoracoabdominal Aortic Aneurysm
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients

Brief summary: Evaluation of the effectiveness of the different modalities for treatment of thoracoabdominal aortic aneurysms. FEVAR and BEVAR devices are widely used now due to its feasability and wide range of use . We aim to evaluate the effectiveness of these new devices in the management of TAAA


Eligibility criteria: Inclusion Criteria:

* all adult consecutive patients presenting with TAAA larger than 5.5 cm

Exclusion Criteria:

* active infection Asymptomatic patients with small aneurysms Allergy to contrast agents

Primary outcomes:
measure: Successful cannulation of the target vessels with complete in-line flow to target organs.
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02576873: Long-term Outcome of End-stage Renal Disease Patients Treated With Hig-efficiency Hemodiafiltration
Official title: Long-term Outcome of End-stage Renal Disease Patients Treated With High-efficiency Hemodiafiltration: a Historical Cohort of a Single-center in South East Asia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End-stage Renal Disease
Keywords: Survival
Hemodiafiltration
End-stage renal disease
Hemodialysis
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 66
Sex: ALL
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: End-stage renal disease patients who had been received long-term hemodiafiltration at King Chulalongkorn Memorial hospital during 2001-2013

Brief summary: A retrospective cohort study was conducted in 66 end-stage renal disease patients who underwent high-efficiency hemodiafiltration technique in King Chulalongkorn Memorial Hospital between 2001-2013 to determine the survival rate as well as other long-term outcome.

Detailed description: Growing evidences suggested the superiority of high-efficiency hemodiafiltration (HDF) which could provide both diffusion and convection in a single therapy compared with the conventional hemodialysis. However, the long-term, upto 10 years, outcome still limited. This retrospective cohort study was conducted in 66 end-stage renal disease patients who underwent high-efficiency hemodiafiltration technique in a single-center, King Chulalongkorn Memorial Hospital, between 2001-2013 to determine the survival rate as well as other long-term outcome

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or more
* Be diagnosed end-stage renal disease for more than one year
* Have been regularly received long-term hemodiafiltration for more than 6 months.

Exclusion Criteria:

* Patients who received hemodiafiltration less than 6 months

Primary outcomes:
measure: Survival rate
timeFrame: 10 years
Secondary outcomes:
measure: Comparison of survival differences between patients who start renal replacement therapy with HDF and who switched from hemodialysis as well as between diabetic and non-diabetic patient.
timeFrame: 10 years
measure: Factors that associated with all-cause mortality
timeFrame: 10 years
Other outcomes:
Locations:
city: Pathumwan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bangkok
Study officials:
affiliation: Chulalongkorn University
name: Khajohn Tiranathanagul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02696473: The Bioavailability of Polyacetylenes From Carrots Study
Official title: Absorption of Naturally Present Compounds in Carrots and Their Appearance in Blood and Other Biofluids After Consumption (The Carrot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Bioavailability
Polyacetylenes
Falcarinol
Falcarindiol
Falcarindiol-3-acetate
Carrot
Biological Availability
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Newcastle University
First posted: 2016-03-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Polyacetylenes, compounds found naturally in carrots, have shown promising anti-cancer and anti-inflammatory actions in vitro but have not been tested in vivo. To determine whether the polyacetylenes could have an effect in vivo, this study aims to determine whether they are detectible in human biofluids after the consumption of a portion of carrots and whether a difference is seen between a large and small portion.

Detailed description: Volunteers will collect urine samples 24 hours prior to the 'test' day and a stool sample either the night before or the morning of the test session. They will have fasted blood taken before eating a portion of carrots with bread and butter. Further blood samples will be taken at 0.5, 1, 2, 3, 4, 6, 8 and 24 hours. All urine and all stool samples (after 4 hours) will be collected up to 48 hours after the carrot dose. They volunteers will attend two test sessions and will be randomised to receive high and low doses of carrot. At least a week will separate testing sessions.

Eligibility criteria: Inclusion Criteria:

* Healthy adults, BMI between 18.5 and 30

Exclusion Criteria:

* Metabolic or gastrointestinal conditions, allergies to carrot or bread, taking any medication that affects metabolism or digestion, smokers

Primary outcomes:
measure: Detection of polyacetylene in biofluids
timeFrame: 72 hours
Secondary outcomes:
measure: Detection of a difference between doses of polyacetylene in biofluids
timeFrame: 72 hours
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Clinical Research Facility, Royal Victoria Infirmary
Study officials:
affiliation: Newcastle University
name: Sarah Warner
role: STUDY_DIRECTOR
References:
Clinical trial NCT01807273: Time Up and go in Hemiplegic Patients
Official title: Quantification of Biomechanical Parameters of Functional Task Time Up and Go in Hemiplegic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Difficulty Walking
Keywords: hemiplegic
time up and go test
motion analysis
center of mass
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 60
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: 60 hemiplegic out patients

Brief summary: Investing the Timed Up and Go (TUG) Test in Hemiplegic Patients Using 3D Motion Analysis

Detailed description: The timed up and go is a routine quick test assessing motor functional tasks including stand up ,walk 3 m,turn around and sitting down.We will included hemiplegic patients to quantify biomechanic parameters

Eligibility criteria: Inclusion Criteria:

* Patients performing 3D gait analysis
* Male or female adults aged ≥ 18 years,
* Hemiplegia following unique stroke- Patients with hemiplegia able to stand up alone,walk and turn around alone without assistance.

Exclusion Criteria:

* Patient with a protective measure,
* Pregnant women, breastfeeding
* Brain damage bilateral cerebellar syndrome, apraxia and / or severe aphasia,
* Patient who received botulinum toxin injection in the 3 months prior to inclusion, patients who underwent surgery of the locomotor system in the 6 months prior to inclusion,
* No affiliation to a social security
* other pathology, complications with significant impact on the activities of walking.

Primary outcomes:
measure: Variability of the center of mass
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
Study officials:
affiliation: HOPITAL RAYMOND POINCARE
name: Nicolas ROCHE, MDPHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00335673: I SAVE - Irbesartan in Mild to Moderate Hypertensive Patients
Official title: Irbesartan in Mild to Moderate Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2006-06-12
Enrollment: 1630
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * To evaluate control rate of Blood Pressure ≤ 140/90 mm Hg in non-diabetic patients, and ≤ 130/80 mm Hg in diabetic patients.
* To determine percentage of patients achieving blood pressure control according to their profile (naïve, switch, patient history, etc...) at the end of the trial.


Eligibility criteria: Inclusion Criteria:

* Patients with proved mild to moderate hypertension.
* Newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension)OR
* Patients who were receiving antihypertensive agents (maximum two - one of them is diuretic) and who in the investigator's opinion would benefit more from switching to the study medication. These patients will undergo a wash out period for not less than 7 days prior to enrollment.

Exclusion Criteria:

* Severe hypertension (Systolic Blood Pressure ≥ 180 mm Hg or Diastolic Blood Pressure ≥ 110 mm Hg).
* Patients with secondary hypertension (for another cause other than type 2 diabetes mellitus).
* Patients with HbA1c \> 10%.
* Significant chronic renal impairment (Serum creatinine \> 2.0 mg/dL).
* Significant liver disease as shown by SGPT/SGOT (ALAT/ASAT) \> 2.5 times the upper limit of the normal range.
* Currently pregnant or lactating females.
* Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
* Any patient who is in need for a combination antihypertensive therapy from the start (from the medical point of view of his physician).
* Known hypersensitivity to irbesartan, other ARBs (Angiotensin Receptor Blockers), hydrochlorothiazide, or other thiazide diuretics.
* Patients with malignancy during the past 5 years, known collagen disease or severe cardiac, cerebrovascular or gastric disease.

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

Primary outcomes:
measure: Reduction in blood pressure to target values according to ESC 2003 guidelines at the end of the study.
timeFrame: During the study conduct
Secondary outcomes:
measure: Occurrence of any side effects leading to treatment discontinuation.
timeFrame: During the study conduct
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Mosaad I Morsi, MBBCh, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT03216473: Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Essential Blepharospasm
Official title: A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of NEURONOX® vs. BOTOX® in Patients With Essential Blepharospasm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Blepharospasm
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2017-07-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in adults with essential blepharospasm.

Detailed description: Subjects are randomly assigned into the two groups at the ratio of 1:1. The purpose of study is to confirm the non-inferiority of Neuronox to Botox in terms of the efficacy and safety in subjects with essential blepharospasm.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 75
* Subjects had to have a confirmed clinical diagnosis of essential blepharospasm requiring treatment by injection

Exclusion Criteria:

* Subjects who underwent surgical operation
* Subjects with Neuroleptic induced blepharospasm

Primary outcomes:
measure: JRS (Jankovic Rating Scale) sum-score
timeFrame: From baseline at 4 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: