louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00443248: Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)).
Official title: A 2-Way Repeatability Study To Investigate Vaginal Blood Flow Before, During And After Visual Sexual Stimulation In Pre- And Post-Menopausal Women With And Without Female Sexual Arousal Disorder, Using The Heat Wash-Out Technique.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sexual Dysfunction, Physiological
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-05
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The Pfizer developed Heat Wash-Out (HWO) system is a software controlled electromechanical system designed to measure vaginal wall blood flow. A small vaginal probe is attached to a control unit. Output data are collected on a PC. By measuring the clearance of heat from the heated probe, a direct measure of absolute blood flow can be obtained. The study will assess the technique's ability to differentiate between pre- and post-menopausal women; with and without Female Sexual Arousal Disorder (FSAD).

Detailed description: Medical Device Development

Eligibility criteria: Inclusion Criteria:

* Pre-menopausal women aged 18-40 (with and without FSAD) or
* Post-menopausal women aged 50-65 (with and without FSAD.
* FSAD must have been present for at least 6 months.

Exclusion Criteria:

* Pregnant or lactating women (pre-menopausal population)
* Systemic Hormone Replacement Therapy (HRT) or Selective Estrogen Receptor Modulator (SERM) (postmenopausal population)
* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disease or other major psychological or sexual disorder.

Primary outcomes:
measure: To assess the safety and toleration of the heat washout device.
timeFrame: 2 weeks
measure: To investigate differences in vaginal blood flow following visual sexual stimulation in pre-menopausal women with and without FSAD.
timeFrame: 2 weeks
Secondary outcomes:
measure: To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Dulwich
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Nedlands
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06876948: NENCA Study on Neurological Complications of Long COVID-19 in Children and Adolescents; Neurophysiological, Electroencephalographic and Neuroradiological Investigation
Official title: STUDY of NEUROLOGICAL COMPLICATIONS of LONG COVID-19 in CHILDREN and ADOLESCENTS; NEUROPSYCHIATRIC, ELECTROENCEPHALOGRAPHIC and NEURORADIOLOGICAL INVESTIGATIONS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long Covid-19
Keywords: Covid-19
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: The study seeks to investigate the neurological effects caused by Covid-19 in children and adolescents in the 6-16 age group. To do this, neuropsychological scales, an EEG and an MRI were used.


Eligibility criteria: Inclusion Criteria:

* Age between 6 years and 16 years and 11 months
* Symptomatology compatible with long neurological COVID, specifically: persistence or appearance of new neurological signs/symptoms (e.g. fatigue, headache, sleep disturbance, cognitive dysfunction, memory difficulties, emotional or mood disorders, vertigo cognitive dysfunction, memory difficulties, emotional or mood disorders, dizziness, dysautonomia, movement disorders movement disorders, ataxia, tremor, epilepsy, muscle weakness, myalgia, hyposmia, hypogeusia hearing loss or tinnitus and/or sensorimotor deficits such as hypoesthesia, dysesthesia) after three months after established SARS-CoV-2 infection, as well as persistence of these symptoms for at least two months, in the absence of a clear aetiology.
* Signature of the appropriate Informed Consent by caregiver(s) and patient(s)

Exclusion Criteria:

* Poor knowledge of the Italian language or other limitation of verbal communication that compromises the subject's ability to perform neuropsychological tests
* Need for sedation to perform brain MRI 7 Tesla
* Neurological or neuropsychiatric disorder diagnosed prior to COVID-19 diagnosis
* Caregiver's failure to sign consent

Primary outcomes:
measure: Changes in cognitive and neuropsychological functions in children and adolescents with Long COVID between T0 and T1.
timeFrame: Test administration at the time of diagnosis of Long COVID (T0) and follow-up after 6-9 months (T1).
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
state: PI
Study officials:
References:
Clinical trial NCT02415348: The Use of Fibroscan to Assess Liver Fibrosis in Patients With Cardiac Pacemakers
Official title: The Use of Fibroscan to Assess Liver Fibrosis in Patients With Cardiac Pacemakers and/or Implantable Cardioverter-Defibrillators
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed to determine if the Fibroscan (Echosens, Paris), a non-invasive, ultrasound-based device used to estimate fibrosis in patients with chronic liver disease, interferes with implanted cardiac pacemaker and/or implantable cardioverter-defibrillators. Recruitment consists of a total of 200 outpatients undergoing routine pacemaker interrogation at a teaching-hospital pacemaker clinic.

Detailed description: Assessment of liver fibrosis in patients with chronic liver diseases provides staging and prognostic information critical in establishing treatment priorities. The gold standard evaluation of liver fibrosis is hampered by the invasive nature of liver biopsies. FibroScan is a non-invasive alternative that has been extensively validated in chronic hepatitis C, chronic hepatitis B, alcoholic liver disease, and non- alcoholic fatty liver disease patients.

To avoid unknown risks of potential interaction, the manufacturer have advised against the use of the device in patients with active implantable medical device including cardiac pacemaker and/or implantable cardioverter-defibrillators(ICD). Review of the literature showed that these two population have been specifically excluded in all previously reported studies.

At the time of writing, no specific reports have demonstrated either safety or potential harm of the FibroScan in patients with pacemaker/ICD. Given the proven benefit of the FibroScan in chronic liver disease and the current policy of excluding patients with pacemaker/ICD in clinical practice, this study aims to formally evaluate the safe use of the FibroScan in this population within the controlled environment of a pacemaker lab.

Eligibility criteria: Inclusion Criteria:

-Any outpatient undergoing routine pacemaker interrogation at pacemaker clinic

Exclusion Criteria:

* Pregnancy
* BMI\>35
* Person with active implantable medical devices other than cardiac pacemaker and/or ICD
* Person who are unable to tolerate lying flat for the FibroScan examination.

Primary outcomes:
measure: Rate of Pacemaker/ICD malfunction
timeFrame: 30 min
measure: Type of Pacemaker/ICD malfunction
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Lawrence Worobetz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04568148: COVID-19 Biorepository
Official title: COVID-19 Biorepository
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Covid-19
SARS-CoV 2
Coronavirus
COVID
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19-positive patients

Brief summary: Establish a COVID-19 biorepository to aid in developing our knowledge of the disease.

Detailed description: While SARS-CoV-2 has some similarities to the SARS-CoV pathogen that led to an epidemic in 2002 and 2003, there is much about the epidemiology, pathogenesis, clinical presentation, diagnosis, and treatment of the novel virus that remains unknown.3 Additional research is needed to explore the nature of the virus, its spectrum of disease, and potential therapies to combat its spread. The aim of this project will be to establish a biorepository of blood samples from patients infected with SARS-CoV-2 that can then be used by investigators to expand our understanding of COVID-19 and its treatment and, in turn, improve patient outcomes.

The COVID-19 biorepository will accomplish the following specific aims:

1. Establish a collection of biospecimens from patients with COVID-19.
2. Establish a link between biospecimens and longitudinal individual patient data, which will be collected and stored in RedCap.
3. Provide biospecimens and unique patient data to researchers investigating COVID-19. Separate IRB approval will be needed for these studies.

Eligibility criteria: Inclusion Criteria:

* The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP).
* The participant has a diagnosis of COVID-19 confirmed by COVID-19 PCR.
* Patient is 18 years of age or older.

Exclusion Criteria:

* Participant declines to participate (living patients only)
* Participant or healthcare surrogate is unable to provide informed consent (living patients only)

Primary outcomes:
measure: Biospecimen Collection
timeFrame: From Enrollment to 3 Months
measure: Establishing Connections
timeFrame: From Enrollment to 3 Months
measure: Continuing COVID Research
timeFrame: From Enrollment to 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: Assistant Professor of Medicine
name: Leslie A Spikes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04535648: Detection of Enterovirus Genotypes by CRISPR Technology
Official title: Rapid Identification and Clinical Transformation of Various Enterovirus Genotypes Based on CRISPR Technology
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Enterovirus Infections
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who came to the Children's Hospital of Fudan University and were diagnosed with enterovirus infection.

Brief summary: CRISPR-enterovirus detection system was constructed in this study for detection variety genotypes of enterovirus rapidly in children suspected or diagnosed as enterovirus infection.

Detailed description: To construct CRISPR-enterovirus detection system, we screened the targets, primers and CrRNA and evaluated the capability of this detecting system. Samples of feces, blood and cerebrospinal fluid (the remainder of routine testing samples) from 500 children with suspected or confirmed enterovirus infection were examined using the CRISPR technique. To evaluate the CRISPR-enterovirus detection system, real-time PCR and traditional PCR as comparison method was implemented. The method of real-time PCR and traditional PCR were used to detect enterovirus and analyze the genotypes of enterovirus, respectively. According to the results of CRISPR-enterovirus detection system and the comparison method, the positive coincidence rate, negative coincidence rate and consistency of the two methods were calculated. Furthermore, the sensitivity and specificity of the CRISPR-enterovirus detection system for detection of enterovirus were calculated.

Eligibility criteria: Inclusion Criteria:

* Patients with clinically suspected or confirmed enterovirus infection

Exclusion Criteria:

* Patients with clinical diagnosis of non-enterovirus infection

Primary outcomes:
measure: Successful construction of CRISPR-enterovirus detection system
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Fudan University
name: Liling Qian
role: STUDY_DIRECTOR
References:
Clinical trial NCT03814148: Efficacy and Safety of Leningrado 5 Association in the Treatment of Hypertension
Official title: Randomized, Double-blind, Double-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Leningrado 5 Association in the Treatment of Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Arterial Hypertension
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2019-01-23
Enrollment: 0
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 study is to evaluate the efficacy and safety of Leningrado 5 association on the treatment of hypertension.


Eligibility criteria: Inclusion Criteria:

* Participants aged 18 years or more;
* Participants diagnosed with hypertension, not controlled by monotherapy and/ or lifestyle modification;

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* BP ≥ 180/110 mmHg;
* Participants with BMI (body mass index) ≥ 40 Kg/m2;
* Previous diagnosis of secondary hypertension;
* History of Target Organ Injury;
* History of cardiovascular, hepatic and renal disease;
* History of gout, Diabetes Mellitus and hypokalemia;
* Current medical history of cancer;
* Current smoking;
* History of alcohol abuse or drug use;
* Pregnancy or risk of pregnancy and lactating patients;
* Known allergy or hypersensitivity to the medicines components used during the clinical trial;
* Participation in clinical trial in the year prior to this study.

Primary outcomes:
measure: Change in systolic blood pressure levels, as measured by ABPM at the initial visit and final visit.
timeFrame: 70 days
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study
timeFrame: 101 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03391648: Incidence of Anesthesia-related Adverse Events and Obstetric Complications After Cesarean Delivery
Official title: Incidence of Anesthesia-related Adverse Events and Obstetric Complications After Cesarean Delivery: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia; Adverse Effect, in Labor and Delivery
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 505
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturients who undergo cesarean section

Brief summary: Recruit the parturients who underwent cesarean delivery at Far Eastern MemorialHospital during 2012-2016. After reviewing medical record related to the pregnancy, demographic data, prenatal exam, laboratory data, indication for cesarean section, perioperative events, etc. will be recorded. Analysis will be focused on incidence, temporal trend, and risk factors of anesthesia-related adverse events and obstetric complications.


Eligibility criteria: Inclusion Criteria:

* all parturients underwent cesarean section at Far Eastern Memorial Hospital during 2012-2016

Exclusion Criteria:

* missing data can't be collect during medical chart review

Primary outcomes:
measure: Incidence of anesthesia-related adverse events
timeFrame: Within 42 days after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
References:
Clinical trial NCT02935348: Whole Body PET-MRI in Paediatric and Adolescent Lymphoma
Official title: Feasibility of Using Whole Body PET-MRI to Stage and Restage Paediatric and Adolescent Hodgkin Lymphoma - a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoma
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 25
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Childhood and adolescent cases of clinically suspected or histologically confirmed Hodgkin Lymphoma

Brief summary: Children and adolescents with Hodgkin lymphoma currently undergo multiple investigations including a separate PET and MRI scans during their treatment.

Investigators want to investigate if a combined PET-MRI scan could give the same information.

Children who join our study will have an extra scan twice during their treatment

Detailed description: Children and adolescents with Hodgkin lymphoma currently undergo multiple investigations including a separate PET and MRI scans during their treatment.

Investigators want to investigate if a combined PET-MRI scan could give the same information.

Children who join our study will have an extra scan twice during their treatment

Routine whole body clinical MRI will be performed according to current clinical standard of care. Axial and coronal imaging from the maxilla to proximal femurs will be performed using a combination of T1 and T2 weighted sequences, with and without gadolinium administration.

Eligibility criteria: Inclusion Criteria:

1. Suspected or histologically confirmed Hodgkin lymphoma
2. Male or female participants
3. Age 0-20 years inclusive
4. Entered into the EuroNet PHL-C1 trial, LP1 trial or successor Euronet trials, including Euronet PHL C2 due to open from 2013 onwards or planned to receive chemotherapy regimens of said trials without being formally entered into the trial.
5. Participant/Guardian/Parental written informed consent

Exclusion Criteria:

1. Participants with contraindications to MRI (including cardiac pacemakers or non-MRI compatible intracranial vascular clips)
2. Participants who are pregnant or nursing

Primary outcomes:
measure: The investigator will determine the technical feasibility of performing functional co-registered combined PET-MRI in this patient group using diffusion-weighted MR imaging.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Centre for Medical Imaging
Study officials:
affiliation: UCL
name: Paul Humphries
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05947448: Efficacy and Safety of Mexartan Potassium Tablets (AZL-M) and Calcium Channel Blockers (CCB) in the Treatment of Adults With Essential Hypertension in Chinese Population: a National Multicenter, Prospective, Observational Study
Official title: Efficacy and Safety of Mexartan Potassium Tablets (AZL-M) and Calcium Channel Blockers (CCB) in the Treatment of Adults With Essential Hypertension in Chinese Population: a National Multicenter, Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Essential Hypertension
Keywords: essential hypertension
Lead sponsor: Hasten Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-17
Enrollment: 1215
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: town hospital

Brief summary: This is a national multicenter, prospective, observational study. It is planned to enroll 1215 patients with newly diagnosed essential hypertension in 80 centers, and divide them into 3 groups according to different treatment plans given by doctors: AZL-M monotherapy group, CCB monotherapy group (amlodipine besylate tablets or nifedipine controlled-release tablets) and AZL-M+CCB (amlodipine besylate tablets or nifedipine controlled-release tablets) combined treatment group. Subjects were visited 4 times at baseline, 1 month, 3 months, and 6 months, and the following key indicators of subjects were measured according to the doctor's decision, and the measurement results were collected


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old (one year old);
2. Patients diagnosed with essential hypertension;
3. Did not receive any antihypertensive drug treatment for at least 3 months before enrollment;
4. Eligible to use 80 mg once-daily AZL-M at baseline or CCB (amlodipine besylate tablets or nifedipine controlled-release tablets) or CCB (besylate Amlodipine tablets or nifedipine controlled-release tablets) + AZL-M 80 mg once-daily combination therapy; Volunteer to participate in this study, understand and sign the written informed consent.

Exclusion Criteria:

1. Used antihypertensive drugs for indications other than hypertension within 3 months before enrollment;
2. Has a history of alcoholism, drug abuse or illegal drug use;
3. Pregnant, breastfeeding women, and those who plan to become pregnant in the near future;
4. Life expectancy is less than one year; Participating in other clinical trials.

Primary outcomes:
measure: the patient's blood pressure reached the target rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Junbo Ge
state: Shanghai
Study officials:
References: