louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00259831: Efficacy of Cold-FX (CVT-E002) in the Prevention of Upper Respiratory Tract Infections in Healthy Adults
Official title: Efficacy of Cold-FX (CVT-E002) in the Prevention of Upper Respiratory Tract Infections in Healthy Adult Employees in Continuing Care Facilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Upper Respiratory Infection
Keywords: cold
influenza
Lead sponsor: Afexa Life Sciences Inc
Sponsor class: INDUSTRY
Collaborators: name: Capital Health, Canada
First posted: 2005-12-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the Study is to determine the prophylactic effects of CVT-E002 treatment for upper respiratory tract infections in healthy adult employees working with residents in continuing care facilities. It is hypothesized that the use of CVT-E002 will effectively reduce the incidence, severity and duration of upper respiratory infections among the participants when compared to placebo.

Detailed description: Eligible continuing care employees will be randomly assigned to either the treatment or placebo group with equal numbers in each group. The treatment will consist of taking two capsules of CVT-E002 (400mg)or placebo every morning, after breakfast, for a period of 12 weeks. The subjects will be given an assessment form to log specific symptoms on a daily basis if they get a cold.

Symptoms include sore throat, runny nose, nasal congestion, hoarseness, cough, earaches, and fever. Subjects will be required to maintain the same dosing even during an upper respiratory infection and will be requested not to take any additional medication for their upper respiratory infection unless prescribed by their family physicians.

Eligibility criteria: Inclusion Criteria:

* age 18-64 years
* not pregnant or breast feeding
* good general health

Exclusion Criteria:

* medical conditions: HIV infection; malignancy; cardiovascular disease; hypertension; renal, pulmonary or hepatic abnormalities; neurologic or psychiatric disease; tuberculosis; multiple sclerosis; recent acute respiratory infection (\<2 weeks)
* medications: warfarin; immunosuppressive therapy; corticosteroids; phenalzine; pentobarbital; haloperidol
* major surgical procedure in the previous six months
* history of alcohol/drug abuse
* pregnancy and lactation in women

Primary outcomes:
measure: To determine the efficacy of CVT-E002 in reducing the number of upper respiratory infections during the study.
Secondary outcomes:
measure: To test if the prophylactic management with CVT-E002 decreases the severity and duration of symptoms related to an upper respiratory tract infection.
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: The Capital Care Group Continuing Care facilities
state: Alberta
Study officials:
affiliation: Capital Health, Canada
name: Gerry Predy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05468931: Prostate Stimulation for Sexual Dysfunction
Official title: Prostate Stimulation for Sexual Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sexual Dysfunction
Erectile Dysfunction
Delayed Ejaculation
Anorgasmia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to use a device to stimulate the prostate with a goal of helping improve symptoms in men with sexual dysfunction.

Detailed description: The purpose of the study is to use a device to stimulate the prostate. The goal of this is to help men with sexual dysfunction. Sexual dysfunction can include conditions like delayed ejaculation (e.g.takes more than 21 minutes to climax) and can hopefully assist them in achieving faster time to ejaculation (e.g. closer to the median of 5.4 minutes in a "normal" individual) along with erectile dysfunction (e.g. the inability to achieve and sustain an erection).

Eligibility criteria: Inclusion Criteria:

* Males \>18 years of age suffering from sexual dysfunction

Exclusion Criteria:

* Individuals who have had a prostatectomy - removal of prostate
* Inability to operate the device for any reason
* Females
* Males \<18 years of age

Primary outcomes:
measure: change in modified International Index of Erectile Dysfunction score
timeFrame: baseline and up to 1 month post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Healthcare, Stanford Hospital
state: California
Study officials:
affiliation: Stanford University
name: Michael Eisenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07009431: MHLDA Nursing Associates Focus Group
Official title: MHLDA Nursing Associates Focus Group
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus Group Study of UK Nursing and Midwifery Council Registrant Nursing Associates Working in Mental Health, Learning Disability and Autism Services
Lead sponsor: Royal Cornwall Hospitals Trust
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Registered Nursing Associates (Nursing and Midwifery Council).employed in NHS; mental health, learning disability or autism services in England.

Brief summary: Focus group study of UK Nursing and Midwifery Council registrant nursing associates working in mental health, learning disability and autism services

Detailed description: This qualitative, contextual study seeks to subject data generated from focus groups to thematic analysis. A survey population of Nursing and Midwifery Council registrant nursing associates working in mental health, learning disability and autism services will be recruited via social media and professional networks. Ethical protocols will be observed during the recruitment process and beyond. Focus group cohort members will be allocated to a specific focus group session. Focus group participation will be limited to one session per volunteer. Participants will be invited to discuss their views, ideas and responses to various questions designed to reflect the research questions and objectives. Focus groups will be conducted via Microsoft Teams. Focus group discussions will be recorded and transcribed, the transcripts will be subjected to thematic analysis. Thematic analysis of focus group transcripts will be conducted using NVivo software (version 15), licensed to the Chief Investigators and Study Sponsors employing organisation (Royal Cornwall Hospitals Trust). Post focus group a follow up email will will be sent to all participants containing a summary of the topics of discussion, confirmation that their focus group participation has been completed and the proposed schedule for publishing the final report, of which they will sent a copy.

Eligibility criteria: Inclusion Criteria:

* Registered Nursing Associates (Nursing and Midwifery Council).
* Employed in NHS; mental health, learning disability or autism services in England.

Exclusion Criteria:

* Non-registered nursing associates.
* Trainee or student nursing associates.
* Registered nursing associates practicing in non MHLDA service.

Primary outcomes:
measure: To present a descriptive representation of the MHLDA nursing associates experience within the context of professional identity and themes reflective of nursing in their care setting
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals Trust
state: Cornwall
Study officials:
References:
Clinical trial NCT02432131: Decompression Sickness in Divers With or Without Patent Foramen Ovale
Official title: Incidences of Decompression Sickness in SCUBA DIVERs With or Without Patent Foramen Ovale (DIVER-PFO); A Double-blinded, Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foramen Ovale, Patent
Decompression Sickness
Lead sponsor: Sejong General Hospital
Sponsor class: OTHER
Collaborators: name: Sejong Research Institute
First posted: 2015-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recreational or occupational SCUBA (self-contained underwater breathing apparatus) divers

Brief summary: The investigators will prospectively estimate incidences of decompression sickness in SCUBA divers with or without patent foramen ovale (PFO). All participants will receive transesophageal echocardiogram and transcranial doppler to ascertain whether they get a PFO. Clinical follow up will be undertaken 3 month after transesophageal echocardiographic evaluation, and every 6 month up to 3 years by E-mailing or telephone interview with self-questionnaire report. All decompression sickness (DC) events or DC-like symptoms will be reviewed by a professional diver, who is a medical doctor and member of DAN-AP, and a neurologist.

Detailed description: PFO was defined as transesophageal echocardiographic (TEE) evidence of infused microbubbles in the left atrium within three cardiac cycles after their appearance in the right atrium, at rest or during Valsalva release. If TEE finding will not be conclusive, we will decide the presence or absence of PFO with supplementary transcranial doppler. It will be blinded to participants, physicians and research persons to perform clinical follow-up. It will be not officially recorded, and will be preserved by another research person, who will not contact study participants.

Eligibility criteria: Inclusion Criteria:

* Divers who experienced fifty dives per year

Exclusion Criteria:

* Decompression sickness within recent 20 dives
* Previous procedure or surgery for closure of PFO or ASD
* Previous cerebral infarction or hemorrhage
* Previous epilepsy
* Previous angina or myocardial infarction

Primary outcomes:
measure: PFO-related decompression sickness
timeFrame: Three years
Secondary outcomes:
measure: Cutaneous or neurological decompression sickness
timeFrame: Three years
measure: All symptoms requiring recompression chamber therapy
timeFrame: Three years
measure: All symptoms developed during ascending or within 30minute after surfacing
timeFrame: Three years
measure: Unexplained death within 2 weeks after diving
timeFrame: Three years
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
state: Gyeonggi
Study officials:
References:
Clinical trial NCT03613831: Multi-center Complex Atrial Tachycardia High-Resolution Mapping Registry (MATH)
Official title: Multi-center Complex Atrial Tachycardia High-Resolution Mapping Registry (MATH)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Atrial Tachycardia (Including Atrial Flutter) Post Atrial Fibrillation Ablation or Cardiac Surgery
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2018-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: An arbitrary sample size of 100 should be enough for this registry study which may cover the focal, macro-reentry, micro-reentry and other types of atrial tachycardia. Assuming that the one-year recurrence rate post complex atrial tachycardia ablation is 30%, the 95% confidence interval of 100 samples shall be 21.2-40.0% (binomial distribution exact method).

As per the current actual situation in China, it is predicted that 70-80 cases may be included for the atrial tachycardia post atrial fibrillation ablation, while 20-30 cases may be included for post cardiac surgery.

Brief summary: This study is an observational study without any hypothesis testing. It intended to observe the clinical application of electrophysiological mapping and catheter ablation of atrial tachycardia post atrial fibrillation ablation or cardiac surgery guided with Rhythmia System.


Eligibility criteria: Inclusion Criteria:

1. Subject with atrial tachycardia (including atrial flutter) post atrial fibrillation ablation or cardiac surgery, which occurred at least 90 days prior to enrollment;
2. Subject is suitable for Rhythmia system and Orion catheter according to relevant clinical guidelines and products instruction for use, per investigator's discretion
3. Subject is age 18 or above;
4. Subject or his/ her legal representive understands and is willing to provide the Informed Consent Form (ICF) and participate in this trail.

Exclusion Criteria:

1. Subject with atrial fibrillation only;
2. Subject is enrolled in any other concurrent study that might interfere with this study;
3. Women of childbearing potential who are or might be pregnant at the time of this study

Primary outcomes:
measure: target patient's type
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT02199431: Study to Evaluate the Effect of a Known and Marketed Product, Itraconazole (Mycosis Treatment) on Lu AF11167 Entering the Body and Subsequently Elimination. The Study is a Drug-drug Interaction Study in Healthy Volunteers.
Official title: Interventional, Open-label, Interaction Study Investigating the Effects of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics and Safety and Tolerability of Lu AF11167 in Healthy Young Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Lu AF11167
Interaction
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2014-07-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a single oral dose of Lu AF11167 with and without administration of multiple oral doses of itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic status as CYP2C19 extensive metabolisers


Eligibility criteria: Inclusion Criteria:

* Subjects be 18 years of age and 55 years of age and with a BMI \>18.5 kg/m2 and \<30.0 kg/m2 at the Screening Visit. Women must not be pregnant or lactating.

Other pre-defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Area under the Lu AF11167 plasma concentration-time curve from zero to infinity (AUC0-inf)
timeFrame: Day 1 and 8
measure: Maximum observed plasma concentration (Cmax) of Lu AF11167
timeFrame: Day 1 and 8
Secondary outcomes:
measure: Area under the Lu AF36201 plasma concentration-time curve from zero to infinity (AUC0-inf)
timeFrame: Day 1 and 8
measure: Maximum observed plasma concentration (Cmax) of Lu AF36201
timeFrame: Day 1 and 8
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT00346931: Phacotrabeculotomy Versus CCI+Phaco in Patients With Borderline Control of Intraocular Pressure
Official title: Phacotrabeculotomy vs. CCI+Phaco in Patients With Borderline Control of Intraocular Pressure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Pseudoexfoliative Glaucoma
Keywords: glaucoma
cataract
surgery
intraocular pressure
phacoemulsification
trabeculotomy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2006-07-04
Enrollment: 9
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether combined cataract and glaucoma surgery (phacotrabeculotomy)is more effective in lowering intraocular pressure than cataract surgery alone in patients with borderline control of intraocular pressure.


Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of Primary Open Angle or Pseudoexfoliative Glaucoma and Cataract

Exclusion Criteria:

* Other glaucoma than POAG or PEX-Glaucoma
* Medically uncontrolled Glaucoma:

IOP \> 24 mmHg with two topical medications IOP \> 21 mmHg with three topical medications

* IOP \< 18 mmHg with two topical medications IOP \< 16 mmHg with three topical medications
* previous ocular surgery
* other ocular pathologies affecting visual acuity
* disorders of immune system

Primary outcomes:
measure: Number of Patients with Constant Intraocular Pressure <18 mmHg with/without medication
Secondary outcomes:
measure: Number of Patients with Constant Intraocular Pressure <18 mmHg without medication
measure: Number of Patients with Constant Intraocular Pressure <21 mmHg with/without medication
measure: Number of Patients needing surgical retreatment
measure: Number of Patients with failure of surgical retreatment
measure: Mean IOP after 1 and 2 years
measure: Mean number of medication after 1 and 2 years
measure: Number of intraoperative complications
measure: comparison of postoperative complications between the groups
measure: Visual acuity
measure: decrease in perimetry
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Vienna
name: Clemens Vass, Univ.Prof.Dr.med.univ.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002231: Safety and Effects of Giving a New HIV Vaccine (GENEVAX-HIV) to HIV-Negative Volunteers
Official title: GENEVAX-HIV (APL 400-003), a Candidate DNA Vaccine: A Pilot Dose Escalation Study of GENEVAX-HIV Delivered Intramuscularly Using the Biojector 2000 in HIV Seronegative Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
HIV Seronegativity
Keywords: Injections, Intramuscular
HIV Antibodies
Immunity, Cellular
AIDS Vaccines
HIV Seronegativity
Dose-Response Relationship, Immunologic
Vaccines, DNA
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to see if it is safe to give GENEVAX-HIV, a new HIV vaccine, to HIV-negative volunteers. This study will also look at how this vaccine affects the immune system of these volunteers.

Detailed description: In this open-label study, volunteers are given an intramuscular injection of GENEVAX-HIV vaccine using the Biojector 2000. Safety measures and immune response are assessed accordingly.

Eligibility criteria: Inclusion Criteria

You may be eligible for this study if you:

* Are 18 - 60 years old.
* Are HIV-negative and in good health.
* Are able to understand how infections such as HIV are spread.
* Agree to use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

* Have hepatitis B or C.
* Have any condition that may prevent you from completing the study.
* Are allergic to bupivacaine, vaccines, or certain local anesthetics.
* Have taken certain medications or have received certain therapies that may affect your immune system.
* Have an immune system disorder or have received therapy for an immune system disorder.
* Have been exposed to HIV within 6 months prior to study entry.
* Have received an experimental HIV vaccine or any other experimental treatment within 30 days prior to study entry.
* Have received blood transfusions within 6 months prior to study entry.
* Abuse alcohol or drugs or have an uncontrolled psychiatric disorder.
* Are pregnant or breast-feeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Univ of Pennsylvania Med Ctr
state: Pennsylvania
Study officials:
name: RR MacGregor
role: STUDY_CHAIR
References:
Clinical trial NCT05956431: RCT Study of Levosimendan Improving Prognosis of Cardiac Arrest
Official title: A Randomized Controlled Clinical Study of Early Application of Levosimendan to Improve Cardiac Dysfunction and Neurological Prognosis in Patients With Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Heart Arrest
Keywords: cardiac arrest
Levosimendan Injection
prognosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Qilu Hospital of Shandong University
First posted: 2023-07-21
Enrollment: 60
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: This study is intended to use a multicenter, double-blind, superior effect, placebo controlled randomized controlled clinical trial to explore the therapeutic effect of Levosimendan (within 6 hours after the recovery of spontaneous circulation) on mortality and multiple organ dysfunction such as heart and brain in patients with cardiac arrest who have recovered from active Cardiopulmonary resuscitation but have low cardiac output syndrome and coma, and the impact of 30-day mortality and neurological function after cardiac arrest.


Eligibility criteria: Inclusion Criteria:

* 1: Age\>18 years old

  2: After active Cardiopulmonary resuscitation, patients with cardiac arrest obtain the recovery of spontaneous circulation (ROSC), which is defined as having palpable arterial pulse lasting for more than 20 minutes

  3: Patients with witnessed cardiac arrest

  4: ROSC lasts for less than 60 minutes

  5: Low cardiac output syndrome after ROSC (LVEF\<40%)

  6: Still in a coma after ROSC, Glasgow score\<8 points

  7: Complete enrollment within 180 minutes after ROSC

Exclusion Criteria:

* 1: Patients receiving extracorporeal Cardiopulmonary resuscitation

  2: Patients with severe neurological deficits prior to cardiac arrest

  3: Patients with severe renal dysfunction (creatinine clearance rate\<30ml/min)

  4: Patients with confirmed or suspected pregnancy

  5: Patients with Intracranial hemorrhage

  6: Patients with end-stage diseases, such as advanced malignant tumors or other severe wasting diseases

  7: Patients who are unwilling to participate in the study

Primary outcomes:
measure: Cerebral Performance Category (CPC)
timeFrame: On the 30th day after cardiac arrest
Secondary outcomes:
measure: Survival rate
timeFrame: after 1 week of resuscitation
measure: Echocardiography
timeFrame: On the first week after resuscitation
measure: Neuron-Specific Enolase (NSE)
timeFrame: On the first week after resuscitation
measure: Gray-to-White Matter Ratio (GWR)
timeFrame: On the first week after resuscitation
measure: Serum creatinine
timeFrame: On the first week after resuscitation
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Ma Qingbian, doctor
role: STUDY_CHAIR
References: