louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00620529: The Effects of Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat in the Polycystic Ovary Syndrome
Official title: A Clinical Trial to Measure the Effect of DHA-enriched Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat Content in the Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Keywords: polycystic ovary syndrome
cardiovascular risk
metabolism
blood pressure
liver fat
heart rate variability
Lead sponsor: Keogh Institute for Medical Research
Sponsor class: OTHER
Collaborators: name: Royal Perth Hospital
First posted: 2008-02-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We hypothesise that fish oils will have a beneficial effect on cardiometabolic parameters in women with PCOS. The purpose of this study therefore is to examine the effects of fish oils on blood pressure, heart rate variability and liver fat content in obese women with the polycystic ovary syndrome.

Detailed description: The prevalence of abnormalities of blood pressure (ABP), variability of heart rate (HRV) and liver fat content is increased in women with the polycystic ovary syndrome (PCOS). We hypothesise that fish oils will have a beneficial effect on these endpoints and other cardiometabolic parameters such as cholesterol and liver function in women with PCOS. This crossover study of 40 obese women with PCOS will therefore examine the effects of fish oils on the above parameters compared with placebo (olive oil). Subjects with PCOS who have participated in previous studies with this research group will be approached for recruitment, as will eligible subjects within the endocrine clinics of the chief and co-investigators.

Eligibility criteria: Inclusion Criteria:

* Overweight/obese women with PCOS as per 1990 NIH criteria (see below)
* Non-smokers
* Age\>18 years, premenopausal
* Acceptable to have/be on treatment for type 2 diabetes mellitus and/or dyslipidaemia
* Acceptable to be taking the oral contraceptive pill

Exclusion Criteria:

* Uncontrolled hypertension (BP\>160/100mmHg)
* Known co-morbidities including liver or renal disease
* Already taking fish oil supplements
* Other intercurrent illness (major surgery, CV event)
* Smokers
* Alcohol intake \>20g/day
* Pregnancy
* Any metallic implant (contraindication for MRI).

Primary outcomes:
measure: 24 hour ambulatory systolic blood pressure
timeFrame: week 8 and week 24
Secondary outcomes:
measure: 24 hour heart rate variability
timeFrame: week 8 and week 24
measure: liver fat content (MRI)
timeFrame: week 8 and week 24
Other outcomes:
Locations:
city: Perth
country: Australia
facility: School of Medicine and Pharmacology, Royal Perth Hospital
state: Western Australia
Study officials:
affiliation: The University of Western Australia
name: Andrea J Cussons, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04757129: Changes of Cardiopulmonary Function After Thrombolysis in Patients With Pulmonary Embolism
Official title: Dynamic Changes of Circulatory and Respiratory Function After Thrombolysis in Patients With Acute Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Pulmonary Embolism
Keywords: acute pulmonary embolism
thrombolysis
Alteplase
cardiopulmonary function
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: medium-high risk or high risk pulmonary embolism and treated with thrombolysis

Brief summary: The investigators expect to enroll about 80-100 acute pulmonary embolism patients treated with thrombolysis in two hospitals. Dynamic changes of cardiopulmonary function after thrombolysis are detected to evaluate which indicators can quickly reflect the effectiveness of thrombolysis.

Detailed description: About 80-100 acute pulmonary embolism(APE) patients treated with thrombolysis are enrolled in the First Affiliated Hospital with Nanjing Medical University and Nanjing Drum Town Hospital from January 1, 2020, to June 30, 2024. According to the 2019 ESC guideline, the standards for thrombolysis in APE patients are as follows: within 2 weeks of onset; high-risk pulmonary embolism; medium-high-risk pulmonary embolism with symptoms of aggravation.

Investigators dynamically monitor cardiopulmonary function of participants after thrombolysis, including blood pressure, heart rate, respiratory rate, blood gas analysis, 2-dimensional echocardiography (left and right ventricular diameter, pulmonary artery pressure, interventricular septum) and laboratory tests (cTnT,pro-BNP).participants are divided into two groups: thrombolytic success group and thrombolytic failure group according the previously reported criterion which is evaluated 48h after thrombolysis.

Cardiopulmonary characteristics are analyzed to seek accurate and rapid index to reflect success of thrombolysis.

Eligibility criteria: Inclusion Criteria:

* medium-high risk or high risk pulmonary embolism and treated with thrombolysis

Exclusion Criteria:

* lack of radiologic evidence to diagnose APE
* death within 48 hours after thrombolytic therapy
* unable to partner treatment and leaving hospitals
* missing other necessary data
* pregnancy

Primary outcomes:
measure: cardiopulmonary function changes
timeFrame: 48 hours after thrombolysis
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT02454829: Follow-up of Ovarian Function in Young Women Who Underwent Ovarian Cortex Cryopreservation
Official title: Follow-up of Ovarian Function in Young Girls and Women Who Underwent Ovarian Cortex Cryopreservation for Fertility Preservation at the Cliniques Universitaires Saint-Luc
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Infertility
Keywords: Ovarian cortex cryopreservation
ovarian function
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 546
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women who underwent ovarian cortex cryopreservation in our institution between 1997 and 2013

Brief summary: Evaluation of ovarian function by a questionnaire and by medical file analysis of women and girls who underwent ovarian cortex cryopreservation for fertility preservation between 1997 an 2013 in the investigators' institution in order to evaluate their residual ovarian function. A second part of the questionnaire concerns these women's satisfaction regarding the procedure.

Detailed description: Between 1997 and december 2013, 546 girls and women underwent ovarian cortex cryopreservation in the investigators' institution for fertility preservation. The main indications were the need for a gonadotoxic treatment, repeated ovarian surgery and a genetic risk for premature ovarian failure . These women will be sent a questionnaire concerning their ovarian function since the procedure and a questionnaire about their satisfaction concerning the procedure. Six different questionnaires will be used adapted to the patient's initial indication for cryopreservation and the patient's age at the time of cryopreservation. Complementary data will be obtained by medical file analysis and by contacting the patient's family doctor or gynecologist.

Data will be correlated with received gonadotoxic treatment and surgical interventions.

The purpose of the study is to improve the indications and patient selection for ovarian cortex cryopreservation.

Eligibility criteria: Inclusion Criteria:

* women who underwent ovarian cortex cryopreservation in our institution between 1997 and 2013

Exclusion Criteria:

* deceased women in this cohort

Primary outcomes:
measure: Persistence of ovarian function
timeFrame: since the cryopreservation procedure (24 up to 216 months)
Secondary outcomes:
measure: Satisfaction with the undergone cryopreservation procedure
timeFrame: at the time of completion of the questionnaire (24 up to 216 months after the cryopreservation procedure)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Pascale Jadoul
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00607529: Clinical Evaluation of an Investigational Blood Creatinine Point-of-Care Test Device
Official title: Clinical Evaluation of an Investigational Blood Creatinine Point-of-Care Test Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Multiple Diseases
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Nova Biomedical Corporation
First posted: 2008-02-05
Enrollment: 99
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: MSKCC patients

Brief summary: This study is being done to see if the Nova Creatinine Meter can give a correct measure of creatinine (a blood test used to measure kidney function) when the blood is taken from a capillary (smallest type of blood vessels). The Nova Creatinine Meter is a hand held device that can be used in a clinic to measure creatinine in about 50 seconds. Current laboratory creatinine testing can take up to an hour. Since chemotherapy patients need to have their creatinine measured prior to treatment, this meter could make testing easier and faster.


Eligibility criteria: Inclusion Criteria:

* Written Informed Consent
* Must have a creatinine \> or = to than 3.5 mg/dl

Exclusion Criteria:

* Patients who are less than 18 years of age

Primary outcomes:
measure: The primary outcomes would be, reduced wait time and increased patient satisfaction.
timeFrame: conclusion of the study
Secondary outcomes:
measure: reduced blood loss
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Martin Fleisher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01360229: Acupuncture for Fatigue in Parkinson's Disease
Official title: Acupuncture as a Symptomatic Treatment for Fatigue in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinsons Disease
Keywords: Parkinsons Disease
Fatigue
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2011-05-25
Enrollment: 94
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safety and effectively treat fatigue in Parkinson's Disease (PD). Eligible subjects will receive either real or sham acupuncture twice weekly for six weeks.


Eligibility criteria: Inclusion Criteria:

* Patients with PD
* Patients 40-99 years of age
* Patients who have significant fatigue
* Patients must be on a stable medication regimen for the treatment of PD

Exclusion Criteria:

* Patients who have had previous acupuncture within the past six months
* Patients who have had deep brain stimulation (DBS)
* Patients with dementia, depression, or sleep disorder
* Patients who are currently taking medications known to affect fatigue, such as stimulants

Primary outcomes:
measure: Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Benzi Kluger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06757829: Pulmonary Functions in Sickle Cell Disease: Response to Acu-TENS
Official title: Pulmonary Functions in Sickle Cell Disease: Response of Adding Acu-TENS to Inspiratory Muscle Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sickle Cell Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: pulmonary complications are common in sickle cell disease patients. Respiratory training using inspiratory muscle trainer (IMT) is usually a good choice to improve these complications. Recently, acupuncture like transcutaneous electrical nerve stimulation (AC-tens) may also improve these complications.

Detailed description: sickle cell disease patients whose number will be forty patients will be divided to group I who will trained with IMT (threshold inspiratory muscle training) and treated with AC-tens (the number of patients will be 20) or group II who will trained with IMT (the number of patients will be 20) . The number of sessions per week will be three sessions for IMT or AC-tens for 12 weeks. the IMT will be performed for six sets of respiratory training cycles and the set will contain 10 respiratory cycles. Also the session of AC-tens will be 45 minute on bilateral Ex-B1 acupoint. the parameters of AC-tens will be four hertz and 200 microsecond pulse duration.

Eligibility criteria: Inclusion Criteria:

* sickle cell disease patients
* non obese patients

Exclusion Criteria:

* patients with any systemic or chest or renal or hepatic or neurological diseases
* women with lactation or pregnancy
* patients atacks of vasoocclusive crisis

Primary outcomes:
measure: FEV1/FVC ratio
timeFrame: it will be assessed after12 weeks
Secondary outcomes:
measure: forced expiratory volume at the first second of expiration
timeFrame: it will be assessed after12 weeks
measure: forced vital capacity
timeFrame: it will be assessed after12 weeks
measure: six minute walk distance
timeFrame: it will be assessed after12 weeks
measure: physical summary of short form 36
timeFrame: it will be assessed after12 weeks
measure: mental summary of short form 36
timeFrame: it will be assessed after12 weeks
measure: right diaphragmatic excrusion
timeFrame: it will be measured after 12 weeks
measure: left diaphragmatic excrusion
timeFrame: it will be measured after 12 weeks
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: faculty of physical therapy Cairo university
state: Giza
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01430429: Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody
Official title: An Open Label Single Arm Study to Investigate the Safety and Efficacy of Multiple Administrations of NI-0801, a Fully Human Anti-CXCL10 Monoclonal Antibody in PBC Patients With an Incomplete Response to Ursodeoxycholic Acid
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Primary Biliary Cirrhosis
Lead sponsor: Light Chain Bioscience - Novimmune SA
Sponsor class: INDUSTRY
First posted: 2011-09-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of the study is to assess safety and efficacy of multiple doses of NI-0801 in primary biliary cirrhosis patients with an inadequate response to ursodeoxycholic acid.


Eligibility criteria: Inclusion Criteria:

* Proven primary biliary cirrhosis (PBC), as demonstrated by the presence of at least 2 of the following 3 diagnostic factor (History of increased alkaline phosphatase levels for at least 6 months; positive serum AMA titer; Liver biopsy consistent with PBC)
* Elevated liver enzyme levels at screening
* Have given written informed consent

Exclusion Criteria:

* Screening bilirubin \> 2.9 mg/dL (50 μmol/L)
* Screening creatinine clearance \< 80 ml/min
* History or presence of hepatic decompensation (e.g., esophageal variceal bleeding, hepatic encephalopathy, or ascites)
* Positive serology result for Human Immunodeficiency Virus (HIV), Hepatitis B or C
* Known or previous diagnosis of malignancy
* Presence of any active infection
* Previous history of active TB within 12 months of screening

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: Birmingham
country: United Kingdom
facility: NIHR Liver Biomedical Research Unit, Queen Elizabeth Hospital
Study officials:
References:
citation: Mousa HS, Lleo A, Invernizzi P, Bowlus CL, Gershwin ME. Advances in pharmacotherapy for primary biliary cirrhosis. Expert Opin Pharmacother. 2015 Apr;16(5):633-43. doi: 10.1517/14656566.2015.998650. Epub 2014 Dec 29.
Clinical trial NCT00061529: A Phase III Study of Brimonidine Tartrate Ophthalmic Solution, 0.15% in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official title: A Phase III Study of Brimonidine Tartrate Ophthalmic Solution, 0.15% in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2003-05-30
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the safety and efficacy of Brimonidine Tartrate Ophthalmic Solution, 0.15% in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: * Patients of any race
* two (2) years of age or older
* of either sex
* diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)or ocular hypertension

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center
state: Texas
Study officials:
References:
Clinical trial NCT01468129: Cell Saver Use in Bilateral Total Hip Arthroplasty (THA)
Official title: A Prospective, Randomized Controlled Trial to Evaluate the Efficacy of Cell Saver to Redue Blood Loss in One-stage Bilateral Total Hip Arthroplasty (THA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: One-stage Bilateral Total Hip Replacement
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2011-11-09
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study will investigate the efficacy of using cell saver during bilater total hip arthroplasty


Eligibility criteria: Inclusion Criteria:

* Subject is over 21 years of age
* Subject with bilateral degenerative disease of hips who are candidate for one-stage bilateral THA
* Subject willing and able to provide written informed consent

Exclusion Criteria:

* Subject with significant comorbidities identified by Charleston index of ≥ 3
* Subject with malignancy
* Subject with history of heart disease, myocardial infarction, pulmonary insufficiency, pulmonary embolus, documented fat emboli syndrome, adult respiratory distress syndrome, documented patent ductus arteriosus or septal defect, chronic renal failure and/or acute hepatic failure or chirhosis
* Subjects with hematologic disorders such as anemia (Hb \< 10 g/dL) and sickle cell disease, acquired or congenital coagulopathies, acquired or congenital bleeding disorders,
* Subject who received anticoagulant such as aspirin or Warfarin (Coumadin) or antiplatelet agents such as clopidogrel (Plavix) within 7 days of surgery
* Subject who received hemostatic agents such as tranexamic acid and aprotinin
* Subjects utilizing acute normovolumic haemodilution
* Subject is not permitted to remain without his/her anti-coagulant regimen (eg Plavix) for 48 hours postoperatively
* Subject is known to be pregnant.
* Subject has erythropoietin agonist/stimulating agent within 90 days prior to surgery.
* Presence of contaminants such as urine, fat, bowel contents, and most importantly infection in the operative field
* Presence of vasoactive drugs such as papaverine in the operative field

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00733629: Study of Endothelial Cells in Patients With Hereditary Haemorrhagic Telangiectasia
Official title: In Vitro Studies pf Endothelial Cells Derived From HHT Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Telangiectasia, Hereditary Hemorrhagic
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2008-08-13
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hereditary haemorrhagic telangiectasia

Brief summary: Hereditary Haemorrhagic Telangiectasia (HHT, also known as Osler-Weber-Rendu Syndrome) is an disease that leads to the development of dilated and fragile blood vessels. We propose to culture endothelial cells from patients with HHT, to culture cells that express the proteins mutated in HHT, namely endoglin and ALK-1. We will study the properties of these cells which will involve their growth in different conditions and anticipate that DNA, mRNA and proteins will be extracted from these cells for study of cell responses and association with expression levels of endoglin and ALK-1. We hypothesize that these cells which express "half-normal" endoglin or ALK-1 will show altered protein synthetic differences when compared to normal white blood cells. We anticipate that that these findings may help to explain aspects of the HHT disease phenotype.


Eligibility criteria: Inclusion Criteria:

* Patients with hereditary haemorrhagic telangiectasia and family members

Exclusion Criteria:

* Unable to provide informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Hammersmith Campus
Study officials:
affiliation: Imperial College London
name: Claire L Shovlin
role: PRINCIPAL_INVESTIGATOR
References: