louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02026531: Novel MRI Techniques in the Evaluation of Pulmonary Vascular Disease
Official title: Novel MRI Techniques in the Evaluation of Pulmonary Vascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pulmonary Hypertension
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Sheffield
First posted: 2014-01-03
Enrollment: 9
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: The diagnosis of a patient with pulmonary hypertension (PH) requires many investigations. At present cardiac catheterisation is the cornerstone investigation in these patients where it is used to establish disease severity and estimate prognosis. It is an invasive procedure which is expensive and not without risk to the patient. Despite the multitude of tests performed, identifying those patients with PH who have a poor diagnosis can be difficult. The aim of this study is to improve the assessment of patients with PH using novel magnetic resonance techniques.


Eligibility criteria: Inclusion Criteria:

* All cases referred to the clinic for assessment for possible pulmonary hypertension.

Exclusion Criteria:

* patients with a cardiac pacemaker or retained temporary pacing wire
* patients with aneurysm clip
* non MRI compatible heart valve prosthesis
* intra orbital metalic foreign body
* pregnancy
* metal prosthesis/spinal rods
* retained shrapnel
* cochlear implants/bladder stimulator

Primary outcomes:
measure: pulmonary artery diameter (mm)
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Pulmonary Vascular Disease Unit, Royal Hallamshire Hospital
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Charlie Elliot, MBChB MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00723931: PegIntron Injection Surveillance Plan (Study P04123)
Official title: PegIntron Injection Surveillance Plan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 1267
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Surveillance will be conducted at digestive departments of internal medicine in university or general hospitals where participants with chronic hepatitis C are generally treated.

Brief summary: Surveillance will be conducted at digestive departments of internal medicine in university or general hospitals where participants with chronic hepatitis C are generally treated. The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of PegIntron Injection under actual conditions of use and to examine adverse events, serious adverse events, and adverse drug reactions.

Detailed description: The investigator will record continuously from the first patient since the day of contract to the numbers of patients of contract based on Pegintron approval.

Eligibility criteria: Inclusion Criteria:

* Participants with chronic hepatitis C treated with peginterferon alfa-2b.

Signed written contract.

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants That Reported a Serious Adverse Event
timeFrame: 24 weeks after administration of PegIntron Injection
measure: Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold
timeFrame: 24 weeks after administration of PegIntron Injection.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05050331: Comparative Effectiveness of Muscle Energy Technique and Trigger Point Release in Plantar Fasciitis
Official title: Effectiveness of Muscle Energy Technique and Trigger Point Release in Plantar Fasciitis: a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis
Keywords: Muscle Energy Technique
Trigger Point Release
Lead sponsor: University of Faisalabad
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the comparative efficacy of Muscle Energy Technique (MET) and Trigger Point Release in the treatment of Plantar Fasciitis. A single-blinded, randomized clinical trial was conducted, wherein thirty participants were randomly assigned to two parallel groups. One group received MET, while the other received Trigger Point Release, with both groups performed self-stretching exercises as part of their home program. Outcome measures included pain intensity and foot function. Treatments were administered three times a week for a duration of four weeks.


Eligibility criteria: Inclusion Criteria:

* Unilateral plantar heel pain that worsens with weight-bearing activities
* Age range: 25-45 years
* Pain exacerbation with initial morning ambulation (i.e., walking a few steps)
* Presence of at least one identifiable trigger point in the calf muscles

Exclusion Criteria:

* Bilateral heel pain
* History of tumors in the leg or foot
* Previous lower limb fractures
* Recent or unresolved lower limb injuries
* Achilles Tendinitis
* Ankle arthritis
* Surgery
* Vascular Disease

Primary outcomes:
measure: Foot Pain
timeFrame: Four Weeks
Secondary outcomes:
measure: Foot Function
timeFrame: Four Weeks
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: The University of Faisalabad
state: Punjab
Study officials:
affiliation: The University of Faisalabad
name: Dr Sidra Majeed; PT, MSPP
role: STUDY_DIRECTOR
References:
Clinical trial NCT00404131: Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease
Official title: A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-11-27
Enrollment: 500
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: The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic Solution with placebo when applied topically in subjects with dry eye disease.


Eligibility criteria: Inclusion Criteria:

* best corrected visual acuity in both eyes of at least +0.7
* six-month documented history of dry eye disease
* at least mild severity in 2 of the 4 dry eye symptoms
* unanesthetized Schirmer score of less than or equal to 7mm
* corneal fluorescein staining of greater than or equal to 4 (out of 15)

Exclusion Criteria:

* nasally stimulated Schirmer score of less than 3mm in subjects with an initial Schirmer score of 0mm
* ongoing contact lens wear
* current topical ophthalmic medication use

Primary outcomes:
measure: Change in dry eye testing measures and symptoms
Secondary outcomes:
measure: Change in dry eye testing measures and symptoms
Other outcomes:
Locations:
Study officials:
name: Amy Schaberg, BSN
role: STUDY_DIRECTOR
References:
citation: Tauber J, Davitt WF, Bokosky JE, Nichols KK, Yerxa BR, Schaberg AE, LaVange LM, Mills-Wilson MC, Kellerman DJ. Double-masked, placebo-controlled safety and efficacy trial of diquafosol tetrasodium (INS365) ophthalmic solution for the treatment of dry eye. Cornea. 2004 Nov;23(8):784-92. doi: 10.1097/01.ico.0000133993.14768.a9.
Clinical trial NCT06338527: Effects of Aromatherapy on Patients Undergoing Chemotherapy for Breast Cancer
Official title: Effects of Aromatherapy on Sleep Quality and Anxiety in Patients Undergoing Chemotherapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep Quality
Anxiety
Keywords: Sleep quality
Anxiety
Aromatherapy
Lead sponsor: Weifang Medical University
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 90
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: The objective of this study was to investigate the effects of aromatherapy on sleep quality and anxiety in patients undergoing chemotherapy for breast cancer.


Eligibility criteria: Inclusion Criteria: 1) patients diagnosed with breast cancer and receiving chemotherapy; 2) suffering from sleep disorders or PSQI score greater than 5; 3) not using medications such as antidepressants and hypnotics that may affect the observation results; 4) age older than 18 years and volunteered to participate in this study.

Exclusion Criteria: 1) Asthma or severe respiratory disease; 2) Allergy to lavender; 3) Cognitive or communication disorders; 4) Breast cancer combined with severe organ dysfunction.

Primary outcomes:
measure: Sleep quality
timeFrame: The sleep quality of the patients was assessed at 8 a.m. for one week.
measure: Anxiety
timeFrame: The anxiety level of the patients was assessed at 8 a.m. for one week.
Secondary outcomes:
Other outcomes:
Locations:
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shangdong
Study officials:
affiliation: Weifang People's Hospital
name: Shirong Fang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03011827: Thromboelastometry in Liver Transplantation
Official title: Transfusion Prediction Model in Orthotopic Liver Transplantation Based on Thromboelastometry: Prospective Validation Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Transplant Disorder
Coagulopathy
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 65
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: TREATMENT

Brief summary: Thromboelastometry better assess coagulation than standard coagulation test in patients undergoing ortothopic liver transplantation. In a post-hoc analysis from a randomized study recently conducted by our group, presurgical values of MA10 Extem \< 35 mm are highly predictive of RBC administration , with no further improvement over MA10 Extem \>40 mm ; suggesting that MA10 Extem between 35-40 would be the optimal range to manage blood product administration. The aim of the study is to validate this result in a prospective cohort of patients submitted to ortothopic liver transplantation.


Eligibility criteria: Inclusion Criteria:

* Presurgical hemoglobin \< 13 d/L and clot firmness at 10 minutes Extem \< 35 mm

Exclusion Criteria:

* Previous thrombosis
* Antithrombotic treatment
* No consent

Primary outcomes:
measure: Red blood cell transfusion
timeFrame: until 24h after liver transplant
Secondary outcomes:
measure: Thrombosis
timeFrame: 28 days after liver transplant
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Bilbao
country: Spain
facility: Hospital de Cruces
Study officials:
affiliation: Hospital Clinic Barcelona. IDIBAPS
name: Annabel Blasi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00511927: Growth Hormone Deficiency in Chronic Heart Failure: an Observational Study
Official title: Observational Study on Prevalence and Prognostic Value of Growth Hormone Deficiency in Patients With Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Cardiomyopathy
Heart Failure
Growth Hormone Deficiency
Keywords: heart
failure
growth
hormone
igf
dilative
cardiomyopathy
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2007-08-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic heart failure due to left ventricular systolic dysfunction

Brief summary: Aim of this study is to define the possible detrimental effect of a lack of growth hormone, on the well-being and life expectation of patients affected by heart failure.

Detailed description: Growth hormone and its main effector IGF-1 have well-documented roles in the regulation of cardiac and circulatory function. Evidence suggests that GH/IGF-1 exert a beneficial effect on cardiac load, cardiac growth and remodeling, despite their hypertrophying action. Several studies in the last years have demonstrated worse cardiovascular outcomes in adult patients with GH deficiency and/or low levels of IGF-1.

A wide range of alterations in the GH/IGF-1 axis have been described to date in patients with chronic heart failure (CHF): reductions in GH levels, reductions in IGF-1 and a pattern of peripheral resistance to GH, in particular in patients with severe heart failure and cardiac cachexia. Our study hypothesis is that an actual status of GH deficiency coexists with CHF in a large percent of patients, and that it may represent a predictor of worse functional status and possibly of a worse prognosis. Aim of this study is to explore the latter hypothesis, comparing the clinical and functional evolution of patients with CHF and GHD with that of a general CHF population.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Heart Failure: NYHA class II to IV, ACC/AHA stage C/D
* Left ventricular end diastolic diameter \>60 mm
* Left ventricular ejection fraction \< 40%
* Clinical stability, guideline-oriented top pharmacological therapy
* Informed consent

Exclusion Criteria:

* Active Myocarditis
* Hypertrophic Cardiomyopathy
* Active endocarditis
* Active malignancy
* End stage renal disease
* Severe liver disease (Child B-C)

Primary outcomes:
measure: overall survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: III Medicina Interna - Federico II University
Study officials:
affiliation: Federico II University
name: Antonio Cittadini, MD
role: STUDY_DIRECTOR
affiliation: Federico II University
name: Luigi Saccà, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02880527: Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy
Official title: Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polymyositis
Dermatomyositis
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 187
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: Patients living in the Normandy with polymyositis / dermatomyositis

Brief summary: Polymyositis and dermatomyositis are characterized by the association to a myopathic syndrome, inflammatory infiltrates in the skeletal muscle. They remain, even today, an important factor of morbidity and mortality in these patients. At present, studies that evaluated the prevalence of polymyositis / dermatomyositis are very few; they were mainly recorded in the United States and Japan, the prevalence of polymyositis / dermatomyositis has been estimated between 3.5 and 21.5 cases / 100 000 (according to the old diagnostic criteria of Bohan and Peter). However, previous works are old and retrospective; above all, they have almost always been performed (90% of cases) from cases reported to the hospital, leading to selection bias and an underestimate of the true prevalence of polymyositis / dermatomyositis in the general population.

Thus, these data lead to achieve this epidemiological study, descriptive, multicenter, based on the population of Normandy.


Eligibility criteria: Inclusion Criteria:

* patients with polymyositis / dermatomyositis, meeting the diagnostic criteria for ENMC;
* patient living Normandy ;
* patient has been informed and has given its verbal agreement ;

Exclusion Criteria:

* patients with myositis diagnosed before inclusion (including pathophysiology, clinical phenotype and therapeutic care are different from polymyositis / dermatomyositis)

Primary outcomes:
measure: Confirmed diagnosis of polymyositis / dermatomyositis
timeFrame: approximately 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Isabelle MARIE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00173927: Images in Extracranial Artery Stenosis
Official title: The Differences in Images of Vertebral Artery Stenosis and Carotid Artery Stenosis Pre- and Post-Percutaneous Transluminal Angioplasty and the Gene Expression Patterns in Peripheral White Blood Cells
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Extracranial Atherosclerosis
Keywords: extracranial atherosclerosis
imaging
biomarkers
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The goals of this trial are:

1. To compare the sensitivity and specificity of various tools including Doppler and magnetic resonance imaging (MRI) for diagnosing vertebral artery stenosis and carotid artery stenosis. The positron emission tomography (PET)/MRI fusion imaging will be a promising tool to provide both anatomical and functional imaging for vulnerable plaques.
2. To identify patients at high risk of plaque rupture by image studies, biomedical profile, and gene expression of circulating monocytes.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic extracranial atherosclerosis who are going to receive angiography and possible intervention.

Exclusion Criteria:

* Acute systemic illness
* Creatinine \> 3 mg/dl
* Unable to tolerate the tests (including MRI and PET/computed tomography \[CT\] scans)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Hsien-Li Kao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03180827: Female Fertility Preservation Using Ovarian Tissue Cryopreservation Before Highly Gonadotoxic Cancer Treatment
Official title: Female Fertility Preservation Using Ovarian Tissue Cryopreservation Before Highly Gonadotoxic Cancer Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Cancer
Fertility Disorders
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Background:

Due to the remarkable improvement in treatments these last decades, long term survival can be expected in more than 80% of childhood cancer patients. Unfortunately, cancer treatments can be harmful to the gonads and can affect reproductive and endocrine functions. While loss of fertility is a major concern for most patients, only the experimental option of ovarian tissue cryopreservation can be proposed to prepubertal girls with a high risk of infertility. For pubertal patient, cryopreservation of mature oocytes after ovarian stimulation can be offered if oncological treatment debut can be delayed. As it is often not possible, ovarian tissue cryopreservation can also be offered.

Primary aims

- To cryopreserve ovarian tissue of pre or peripubertal patient who will be receiving highly gonadotoxic oncological treatment.

Secondary aims

* To create a database in order to record clinical and biological follow-up data
* To pool resources with Fertisave Registry
* To create a research biobank for future research projects

Multicentric study: HUG, CHUV


Eligibility criteria: Inclusion Criteria:

* Pediatric pre ou peripubertal patient aged 2 months and older
* Patient presenting high risk of infertility because of gonadotoxic treatments (i.e. high dose of alkylating agents, ovarian irradiation, total body irradiation)
* Multidisciplinary team consensus in favour to proposition to cryopreserve ovarian tissue.

Exclusion Criteria:

* Patient under the age of 2 months
* Refusal of the patient and/or her parents
* Treatments that are not highly gonadotoxic

Primary outcomes:
measure: Number of pediatric cancer patient who will undergo ovarian tissue cryopreservation for fertility preservation
timeFrame: 0-20 years
Secondary outcomes:
measure: Incidence of complications related to the ovarian biopsy (safety)
timeFrame: 0-20 years
measure: Comparison of biochemical markers
timeFrame: 0-20 years
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
city: Lausanne
country: Switzerland
facility: CHUV
Study officials:
affiliation: University Hospital, Geneva
name: Fabienne Gumy-Pause, Dr
role: STUDY_CHAIR
References: