louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06175481: Correlation Between Popliteal Vein Compliance and Venous Clinical Severity Score
Official title: Correlation Between Popliteal Vein Compliance and Venous Clinical Severity Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Venous Disease (CVD), Vein Compliance, Venous Clinical Severity Score (VCSS)
Lead sponsor: Guangdong Second Provincial General Hospital
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 173
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were prospectively enrolled in Guangdong Second Provincial General Hospital from May 2023 to October 2023. All participants gave their voluntary consent.

Brief summary: When the liquid flow increases, the luminal caliber's stretching amplitude decreases, leading to a higher hydraulic pressure according to Poiseuille's law. In this study, investigators measured the caliber change of the popliteal vein under a rated pressure gradient and evaluated the relationship between popliteal vein compliance and venous clinical severity score (VCSS).


Eligibility criteria: Inclusion Criteria:

* C1 to C6 disease using the CEAP (clinical, etiologic, anatomic, pathophysiologic) classification.

Exclusion Criteria:

* acute or chronic thrombosis of deep veins, previously received intravenous surgery or injection sclerotherapy, ankle brachial index\<0.90, and concomitant cardiovascular, pulmonary, renal, or metabolic diseases.

Primary outcomes:
measure: Compliance of the popliteal vein
timeFrame: May 2023 to October 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Hao Liu
state: Guangdong
Study officials:
References:
Clinical trial NCT03890081: Reliability and Validity of the Turkish Version of the Coping Strategies Questionnaire
Official title: Coping Strategies Questionnaire: Translation, Cultural Adaptation, Reliability and Validity in Turkish-Speaking Subjects With Chronic Musculoskeletal Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Musculoskeletal Pain
Keywords: Coping Strategies Questionnaire
Cross-cultural adaptation
Reliability
Validity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic musculoskeletal pain.

Brief summary: Chronic musculoskeletal pain is a major health problem in 35% of the general population in most developed countries. In addition to interventional therapies, the cognitive and behavioral abilities of the patient, are important for the solution of chronic pain. All of these abilities of patients are called coping strategies of pain.

Detailed description: The Coping Strategies Questionnaire (CSQ) is commonly used to measure methods of coping with various forms of chronic pain, including musculoskeletal pain. CSQ aims to evaluate the frequency and success of coping strategies with cognitive and behavioral pain. The validity and reliability of the questionnaire was tested and satisfactory results were obtained and it became a widely used tool in pain studies. The aim of this study was to translate and culturally adapt the original English version of the CSQ into Turkish version and to assess the validity and reliability of this instrument in patients with chronic musculoskeletal pain.

Eligibility criteria: Inclusion Criteria:

* Being eighteen years old or older,
* being diagnosed with chronic musculoskeletal pain (at least 6 months),
* Being a native Turkish speaker and being able to read Turkish,
* Receiving no treatment between test-retest assessments.

Exclusion Criteria:

* Inability to complete the form due to significant psychiatric or psychological disorder,
* having a neurological disease,
* Pregnant women.

Primary outcomes:
measure: Reliability of Coping Strategies Questionnaire (CSQ)
timeFrame: 1 year
measure: Validity of Coping Strategies Questionnaire (CSQ)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
state: Yenimahalle
Study officials:
affiliation: Gazi University
name: Selda BAŞAR
role: STUDY_CHAIR
References:
Clinical trial NCT01813981: The Effect of High and Low Roasted Coffee on Vascular Response
Official title: The Effect of High and Low Roasted Coffee on Vascular Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 19
Sex: MALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Evidence suggests that a diet rich in plant phenolic compounds may induce beneficial vascular effects. Coffee is a good source of phenolic compounds called chlorogenic acids (CGA), however the level of CGA is reduced during the roasting process.

The aim of this study is to investigate the effect of coffee roasting on vascular response. The investigators hypothesize that coffee roasted to a lesser extent will exert a favourable vascular response over more heavily roasted coffee due to the higher levels of CGA.


Eligibility criteria: Inclusion Criteria:

* Male
* A signed consent form
* Age 19-35 years
* Body mass index - 18.5-30 kg/m2
* Normal blood pressure at screening (\< 150/90)

Exclusion Criteria:

* Blood pressure \> 150/90 mmHg
* Haemoglobin (anaemia marker) \< 125 g/l
* Gamma GT (liver enzymes) \> 80 IU/l
* Cholesterol \> 6.5 mmol/l
* Had suffered a myocardial infarction or stroke in the previous 12 months
* Suffers from any reproductive disorder
* Suffers from any blood-clotting disorder
* Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
* Any dietary restrictions or on a weight reducing diet
* Drinking more than 21 units per week
* On any lipid-modifying medication
* On any blood pressure lowering medication
* On any medication affecting blood clotting
* Planning on altering consumption of vitamin supplements/fish oil capsules during the course of the study
* Regular or vigorous exercise (3 times/week, 20 minutes each session)
* Smoking
* Vegetarians or vegans

Primary outcomes:
measure: Vascular response measured by flow mediated dilatation (FMD)
timeFrame: Change from baseline to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Department of Food and Nutritional Sciences
state: Berkshire
city: Reading
country: United Kingdom
facility: University of Reading
state: England
Study officials:
affiliation: University of Reading
name: Jeremy PE Spencer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mills CE, Flury A, Marmet C, Poquet L, Rimoldi SF, Sartori C, Rexhaj E, Brenner R, Allemann Y, Zimmermann D, Gibson GR, Mottram DS, Oruna-Concha MJ, Actis-Goretta L, Spencer JPE. Mediation of coffee-induced improvements in human vascular function by chlorogenic acids and its metabolites: Two randomized, controlled, crossover intervention trials. Clin Nutr. 2017 Dec;36(6):1520-1529. doi: 10.1016/j.clnu.2016.11.013. Epub 2016 Nov 30.
Clinical trial NCT06522581: Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy
Official title: Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hypoxic Ischemic Encephalopathy of Newborn
Lead sponsor: Armed Forces Hospital, Pakistan
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypoxic ischemic encephalopathy is an acute or subacute brain injury, due to asphyxia in neonates, leading to mortality and long-term morbidity. Its prevalence varies across regions, with developed countries reporting rates of 1.5 per 1000 live births, while developing nations experience a wider range from 2.3 to 26.5 per 1000 live births.

Infants afflicted with moderate HIE face a 10% risk of mortality, with surviving individuals encountering a 30% chance of developing disabilities. The prognosis is graver for severe HIE, with a mortality risk of 60%, and nearly all survivors experiencing some form of disability.

Detailed description: A number of treatment modalities are available but are not clinically effective due to inefficacy and undesirable side effects. Despite therapeutic hypothermia being the sole effective neuroprotector to date, its applicability is limited in certain scenarios, such as gestational age below 36 weeks, birth weight under 2000 g, and initiation beyond 6 hours of age. Therefore, there is a critical need to explore alternative, safe, effective, and accessible neuroprotective therapies, particularly in developing nations.

Citicoline, cytidine 5-diphosphocholine, is an exogenous substance and a product of rate limiting step of phosphatidyl choline synthesis. It has rapid absorption through enteral route where it breaks into cytidine and choline. Citicoline is a favorable recently developed neuroprotector in HIE as it helps to regenerate neuronal cells by inhibiting different steps of ischemic cascade like inhibiting glutamate built up and ROS synthesis increasing dopamine and acetylcholine neurotransmitters, regenerating injured cell membrane and increasing brain plasticity and repair.

In this study, effects of citicoline as a neuroprotector are evaluated in neonates with moderate and severe HIE.

Eligibility criteria: Inclusion Criteria:

1. all indoor newborn babies with HIE II and III
2. who have not received therapeutic hypothermia

Exclusion Criteria:

1. grade I HIE
2. Babies on TH
3. babies whose parents do not give consent for inclusion in study
4. babies with major congential malformations -

Primary outcomes:
measure: survival in newborn babies with HIE
timeFrame: one year after the start of study
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: MH
Study officials:
affiliation: PEMH
name: arshad Khushdil, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01013181: Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP) in the " Real-life " : Result of the French Experience in 72 Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombopenia
Keywords: Immune Thrombopenia
Thrombocytopenia
romiplostim
compassionate program
Lead sponsor: Henri Mondor University Hospital
Sponsor class: OTHER
Collaborators: name: Amgen
name: Paris 12 Val de Marne University
First posted: 2009-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with primary Immune Thrombopenia receiving romiplostim in a compasionnate program

Brief summary: The purpose of this study is to review the charts of the first 100 patients included in the french compassionate program including patients with Immune Thrombopenia receiving romiplostim.

Detailed description: Inclusion Criteria:

* Subject has a diagnosis of ITP according to the American Society of Hematology guidelines (George et al., 1996).
* Subject is equal to or greater than 18 years of age.
* Before any study-specific procedure, the appropriate written informed consent must be obtained.
* Subject receiving romiplostim in the compassionate program
* Available follow-up of one-year

Exclusion Criteria:

•Secondary ITP e.g: thrombopenia related to hepatitis C, HIV, Chronic Lymphocytic Leukemia...

The goal of this study is to review retrospectively the charts of the 100 first patients including in this program in France during the period of January 2008 and July 2008.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:

  * Subject has a diagnosis of ITP according to the American Society of Hematology guidelines (George et al., 1996).
  * Subject is equal to or greater than 18 years of age.
  * Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria:

* Exclusion Criteria:

  * Secondary ITP

Primary outcomes:
measure: Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Khellaf M, Michel M, Quittet P, Viallard JF, Alexis M, Roudot-Thoraval F, Cheze S, Durand JM, Lefrere F, Galicier L, Lambotte O, Panelatti G, Slama B, Damaj G, Sebahoun G, Gyan E, Delbrel X, Dhedin N, Royer B, Schleinitz N, Rossi JF, Mahevas M, Languille L, Bierling P, Godeau B. Romiplostim safety and efficacy for immune thrombocytopenia in clinical practice: 2-year results of 72 adults in a romiplostim compassionate-use program. Blood. 2011 Oct 20;118(16):4338-45. doi: 10.1182/blood-2011-03-340166. Epub 2011 Aug 10.
Clinical trial NCT06337981: Efficacy and Safety of AJU-S56 in Dry Eye Syndrome Patients
Official title: A Phase 2 Multicenter, Randomized, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AJU-S56 in Patients With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Keywords: Dry eye
Lead sponsor: AJU Pharm Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: GL Pharm Tech Corporation
First posted: 2024-03-29
Enrollment: 99
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56) compared to control drug(vehicle) in Patients with Dry Eye Disease.


Eligibility criteria: Inclusion Criteria:

* Male and Female who over 19 years old
* Moderate to Severe Dry Eye Disease Patients
* Must meet all criteria listed below at least in one eye or both eyes. TCSS (National eye institute (NEI) scale)≥ 4 Schirmer test(without anesthesia) ≤ 10mm in 5 mins Tear break-up time ≤ 6 secs
* Written informed consent to participate in the trial

Exclusion Criteria:

* Those who have clinically significant eye disease not related to dry eye syndrome
* Those who have medical history with intraocular surgery 12months before screening visit
* Use of corticosteroid, beta blocker and anticholinergic agent within 4 weeks
* Participation in other studies within 4weeks of screening visit

Primary outcomes:
measure: Total corneal staining score (TCSS)
timeFrame: WEEK 4(Visit 4) (*Baseline, Visit 2 is performed in Day 0, Week 0)
Secondary outcomes:
measure: LGCSS
timeFrame: WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0)
measure: TFBUT
timeFrame: WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: AJU Pharm Co., Ltd.
Study officials:
References:
Clinical trial NCT05492981: Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women?
Official title: Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aneuploidy
Down Syndrome
Pregnancy Early
Keywords: prenatal
Screening
informed choice
randomized controlled trial
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 286
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Informed decision-making regarding aneuploidy screening has been reported to be low. Poor knowledge and the lack of deliberation have been cited as reasons for uninformed choices, highlighting the need for adequate pre-test counselling. We conducted a study to assess if an educational video improves informed choice in a clinical setting where both the combined first trimester screen and non-invasive prenatal screening are offered routinely to pregnant women.

Detailed description: Women attending the antenatal clinic with a viable singleton pregnancy below 14 weeks were randomized to receive routine counselling by their obstetrician or the intervention, where they watched a 16-minute educational video on aneuploidy screening before their consult. The primary outcome, rate of informed choice, was assessed using an adapted multidimensional measure of informed choice (MMIC) questionnaire, where informed choice was defined as good knowledge and value-consistent behaviour. Secondary outcomes included informed choice with deliberation, decisional conflict and anxiety.

Eligibility criteria: Inclusion Criteria:

* aged 21 years or older
* English speaking
* had a viable singleton pregnancy below 14 weeks gestation

Exclusion Criteria:

* women who had any prior discussion with a clinician regarding aneuploidy screening for their current pregnancy

Primary outcomes:
measure: Informed choice
timeFrame: Day 0
Secondary outcomes:
measure: Deliberation
timeFrame: Day 0
measure: Knowledge
timeFrame: Day 0
measure: Value-consistent behaviour
timeFrame: Day 0
measure: anxiety
timeFrame: Day 0
measure: Decisional Conflict
timeFrame: Day 0
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
Clinical trial NCT05474781: Eliminating HCV Infection Among PWUD
Official title: Micro-elimination of HCV Infection Among People Who Use Drug (PWUD) in British.Columbia: A Comprehensive, Multidisciplinary, Scalable Programmatic Approach
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C, Chronic
Drug Use
Lead sponsor: Vancouver Infectious Diseases Centre
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HCV-infected current drug users

Brief summary: Identify 300 PWUD with chronic, viremic HCV infection and engage them in a multidisciplinary, generalizable model of care and initiate HCV treatment


Eligibility criteria: Inclusion Criteria:

1. Ability to review, sign and date the IRB/IEC approved informed consent form
2. Age ≥19 years
3. Documented HCV RNA positive for 6 months or more, with any HCV genotype
4. Active PWUD (ongoing drug use or documented use within the previous 6 months) OR active enrolment in an opiate substitution program

Exclusion Criteria:

1. Previous DAA-based HCV treatment
2. Pregnant or breast-feeding
3. Indications of decompensated liver disease
4. Diagnosis of active hepatocellular carcinoma
5. Positive test at the time of screening for hepatitis B surface antigen (HBsAg)
6. Frequent injecting drug use that is judged by the treating physician to compromise subsequent HCV treatment safety
7. Inability or unwillingness to provide informed consent or to actively engage in care leading to the initiation of HCV treatment

Primary outcomes:
measure: The proportion of individuals enrolled in the study who initiate HCV treatment
timeFrame: 60 months
Secondary outcomes:
measure: The proportion of individuals enrolled in the study who achieve sustained virologic response
timeFrame: 72 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Infectious Diseases Centre
state: British Columbia
Study officials:
References:
Clinical trial NCT06571981: Conventional Ultrasound Versus Remote Ultraportable ulTrasound in the Context of Viral Hepatitis
Official title: Comparison Between Conventional Ultrasound and Remote Ultraportable ulTrasound for Abdominal Examination in the Context of Viral Hepatitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis
Teleradiology
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 102
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: Every outpatient referred to the radiology department by a prescriber for abdominal US in the context of viral hepatitis

Brief summary: Comparison of abdominal US exam in patients with viral hepatitis between ultraportable US with teleradiology capacities (TUP) versus conventional ultrasound (CUS)

Detailed description: Primary Objective The investigation seeks primarily to determine the performance of abdominal US examinations realized with TUP and CUS based on defined imaging criteria Secondary Objectives Evaluate satisfaction and comfort and reproducibility of use of the ultraportable US

Eligibility criteria: Inclusion Criteria:

* Informed Consent signed by the subject
* All adult patients with viral hepatitis for which an ultrasound is planned

Exclusion Criteria:

* Known or suspected non-compliance
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Previous enrollment into the current study

Primary outcomes:
measure: Comparison of TUP versus CUS for abdominal imaging in patients with viral hepatitis according to US LI-RADS categories ) for liver lesions
timeFrame: At the end of intervention
Secondary outcomes:
measure: liver visualization scores
timeFrame: At the end of intervention
measure: liver surface nodularity
timeFrame: At the end of intervention
measure: focal lesions
timeFrame: At the end of intervention
measure: caudate lobe dimensions
timeFrame: At the end of intervention
measure: portal flow velocity
timeFrame: At the end of intervention
measure: biliary tract / gallbladder abnormalities
timeFrame: At the end of intervention
measure: lymph nodes presence
timeFrame: At the end of intervention
measure: free fluid
timeFrame: At the end of intervention
measure: examination time
timeFrame: At the end of intervention
measure: audio quality
timeFrame: At the end of intervention
measure: video quality
timeFrame: At the end of intervention
measure: patient's satisfaction
timeFrame: At the end of intervention
measure: agreement rates between reports
timeFrame: At the end of intervention
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
state: Vaud
Study officials:
affiliation: CHUV-UNIL
name: Naïk Vietti Violi, MD
role: STUDY_DIRECTOR
References: