louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01585012: Usability Study of the Focus Touch™ Conception System: Semen Collection
Official title: Phase 2 Human Factors Usability Study of the Focus Touch™ Conception System: Semen Collection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Infertility
Keywords: Cervical cap insemination
Collection condom
Instructions for Use
Safety during intercourse
Acceptability of the cervical cap with condom sheath
slip
break
ease of conversion
adequate sample collection
Lead sponsor: Rinovum Women's Health, Inc.
Sponsor class: INDUSTRY
First posted: 2012-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This is a human factors usability study designed to validated usability by obtaining feedback in a home use environment regarding ease of use of the Focus Touch™ Conception System Conceptacle (when used to collect semen) and the instructions for use. The investigators will collect data to demonstrate that the usability requirements of the conception system as collection device, as determined by Usability Specification: Focus Touch Conception System, ER-000001 have been met. The ability of the device to be used during sexual intercourse without discomfort or injury to the female participant's vaginal/cervical tissues shall also be taken into account. Participating couples will be asked to use the Focus Touch™ Conception System Conceptacle (in condom form), using the Instructions For Use, to collect semen during sexual intercourse in a home use environment. This study will involve sexual intercourse between monogamous, heterosexual couples who are trying to conceive or are on a non-vaginal birth control with which they do not normally use condoms. Participants will be asked to complete the study and the questionnaire within 3 days of receiving the study packet. Contact information shall be collected, but participants will only be contacted if they fail to return the questionnaire within the requested timeframe.


Eligibility criteria: Inclusion Criteria:

* Heterosexual, monogamous couples, of any race or ethnicity, who are sexually active
* 20 - 50 years of age
* Signed Informed Consent
* Past experience with using condoms
* Trying to conceive or using a non-vaginal birth control with which they do not normally use a condom.

Exclusion Criteria:

* Vaginal tract medical interventions with the last three (3) month
* Vaginal prolapse
* Full Hysterectomy

Primary outcomes:
measure: The primary objective is to determine if the Focus Touch™ Conception System Conceptacle is functionally acceptable and meets the user's needs and expectations when used in the home during sexual intercourse as a semen collection device.
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Monroeville
country: United States
facility: Forbes Regional Hospital
state: Pennsylvania
Study officials:
affiliation: Forbes Regional
name: Michael J Pelekanos, OB-GYN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03021512: Functional Assessment of ADL in Patients Who Underwent Bifocal and Trifocal Presbyopic Correction
Official title: Retrospective Functional Assessment of Activities of Daily Living (ADL) in Patients Who Underwent Bilateral Implantation of Aspheric Bifocal Intraocular Lenses or Aspheric Trifocal Intraocular Lenses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Presbyopia
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Grade 1 Cataract Patients

Brief summary: Patients who underwent bilateral bifocal or trifocal lenses implantation for presbyopia correction with monofocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require: a) distant vision (DV), (ie. driving), b) intermediate vision (IV), (ie. computer word processing), c) near vision (NV), (ie. book reading). Primary objective of the study is the comparison in a series of ADLs of two cohorts of patients (group 1: subjects with bilateral bifocal lenses implantation, group 2: subjects with bilateral trifocal lenses implantation)


Eligibility criteria: Inclusion Criteria:

* Presbyopic patients that underwent either bilateral bifocal or trifocal intraocular lenses implantation

Exclusion Criteria:

* Glaucoma, Corneal pathology, Fundus pathology, Mental or Neurological disorder

Primary outcomes:
measure: Visual Capacity (VC)
timeFrame: 1 year following surgery
Secondary outcomes:
measure: Distant Visual Capacity (DVC)
timeFrame: 1 year following surgery
measure: Intermediate Visual Capacity (IVC)
timeFrame: 1 year following surgery
measure: Near Visual Capacity (NVC)
timeFrame: 1 year follwoing surgery
Other outcomes:
Locations:
city: Alexandhroupolis
country: Greece
facility: Democritus University of Thrace
state: Evros
Study officials:
affiliation: Assistant Professor
name: Georgios Labiris, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00053612: Vitamin A to Reduce HIV in Vaginal Secretions and Prevent Viral Transmission
Official title: Prevention of HIV Shedding in Women - Trial of Vitamin A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Vitamin A Deficiency
HIV Seronegativity
Keywords: HIV-1
Women
Vitamin A
Shedding
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2003-02-05
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: HIV infected individuals with vitamin A deficiency may be more likely to transmit the virus to others than HIV infected individuals who have normal levels of vitamin A. The presence of HIV DNA in vaginal secretions may indicate a greater risk for transmission of HIV to others. The purpose of this study is to determine if taking vitamin A decreases the level of HIV DNA in vaginal secretions.

Detailed description: Vitamin A deficiency leads to pathological changes in mucosal epithelium, including the vagina, and is correlated with immune dysfunction in both HIV-1 infected and uninfected individuals. Recent studies of genital tract shedding of HIV-1 DNA in infected women have found that lower serum concentrations of vitamin A were strongly associated with detection of HIV-1 in vaginal secretions. In addition, maternal vitamin A deficiency has been associated with significantly increased risk of vertical HIV-1 transmission. This study will assess the effect of vitamin A supplementation on the prevalence and quantity of HIV-1 DNA and RNA in cervical and vaginal secretions.

Participants in this study will be HIV infected nonpregnant women in Mombasa, Kenya. Participants will be randomized to receive 6 weeks of daily dosage of either 10,000 IU vitamin A or placebo. Cervical and vaginal swabs will be obtained at enrollment and at Week 6 for detection and quantification of HIV-1 DNA and RNA. In addition, venous blood will be obtained at the two time points for quantification of plasma HIV-1 RNA, CD4 lymphocyte count, and serum vitamin A levels.

Eligibility criteria: Inclusion Criteria:

* HIV infected

Exlusion Criteria:

* Pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universiy of Washington, Seattle, WA
name: Joan Kreiss, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00346112: Rehabilitation, Quality of Life, and Exercise Tolerance in Patients With an ICD
Official title: Rehabilitation, Quality of Life, and Exercise Tolerance in Internal Cardioverter-Defibrillator-patients, RELAX-ICD Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Patients After ICD Implantation
Keywords: ICD
distress
anxiety
quality-of-life
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2006-06-29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: RELAX-ICD Trial/Research Study; Quality of Life/Protocol No.P-KARE-01: A 3-month outpatient rehabilitation therapy and psychological counselling including informative talks with conventional therapy, by a cardiologist or general practitioner after implantation of an internal cardioverter defibrillator (ICD) in adult patients, whereby the effects of three different strategies are compared. Study hypothesis: the rehabilitation programme will be beneficial in the management of any psychological problems possibly as a result from the intervention, and will help to overcome anxiety, and contribute to improved quality of life.

Detailed description: University Hospital Inselspital Berne,Switzerland: Site Nr. 1 - Jean-Paul Schmid, MD, ... recruiting / Virga Jesseziekenhuis,Hasselt, Belgium: Site No. 2 - Paul Dendale,MD,.... recruiting / Medical University of Gdansk, Poland, Site No. 3 - Dominika Zielinska,PhD,.... recruiting / Cliniques Universitaires Saint Luc, Brussel, Belgium: Site No. 4 - Christian Brohet,MD Prof.... recruiting / State Hospital for Cardiology, Balantonfüred, Hungary: Site No. 5 - Gabor Veress, MD Prof, ...recruiting

Eligibility criteria: Inclusion Criteria:

* First ICD implant within past 12 weeks
* Agrees to sign patient/partner informed consent

Exclusion Criteria:

* Angina pectoris CCS III \& IV
* NYHA functional class IV
* Inability to follow rehabilitation programme
* Exercise limitations due to clinical condition
* Symptomatic exercise-induced tachyarrhythmias
* Any major non-cardiac condition that would adversely affect survival during study duration
* Unable to comply to study procedures
* Participates in a concurrent study

Primary outcomes:
measure: Anxiety and Depression
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital (Inselspital) Berne
Study officials:
affiliation: Switzerland - University Hospital (Inselspital) Bern
name: Jean-Paul Schmid
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01471912: Elongation of Foveal Tissue After Macular Hole Surgery
Official title: Asymmetric Elongation of Foveal Tissue After Macular Hole Surgery and Its Impact on Metamorphopsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Holes
Keywords: Macular Holes
spectral domain optical coherence tomography
elongation of foveal tissue
M-score
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 31
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In our experience, elongation of foveal tissue after macular hole surgery which was undetectable by conventional time-domain optical coherence tomography was often observed on spectral-domain optical coherence tomography images. Elongation of tissues inevitably induces some degree of disorganization of tissue microstructure.

The purpose of the present study was to evaluate elongation profile of foveal tissue after macular hole surgery and to investigate its impact on visual acuity and metamorphopsia.


Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed with idiopathic macular hole

Exclusion Criteria:

* traumatic macular hole
* evidence of ocular inflammation, diabetic retinopathy, hypertensive retinopathy, and retinal vasculitis, media opacity that would influence visual acuity or preclude acquisition of clear spectral domain optical coherence tomography images
* presence of cataract judged to affect visual function, -6.0 diopters or more of spherical equivalent, prominent staphyloma
* history of intraocular surgery other than uncomplicated cataract surgery, other ocular diseases that may influence the macular microstructure or visual function
* patients with indistinct intraretinal structure on spectral domain optical coherence tomography images

Primary outcomes:
measure: Changes in the inter-outer plexiform layer distance
timeFrame: first postoperative visit, 1 month, 2 months, and 6 months after macular hole surgery
measure: Changes in best-corrected visual acuity
timeFrame: first postoperative visit, 2 months, and 6 months after macular hole surgery
measure: Changes in degree of metamorphopsia
timeFrame: first postoperative visit, 2 months, and 6 months after macular hole surgery
measure: Degree of percent asymmetric elongation on the same plane
timeFrame: at 6 months postoperative
measure: Degree of horizontal-vertical percent asymmetry
timeFrame: at 6 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT02019212: Prognostic Value of Stress SPECT Myocardial Perfusion Imaging With Half Dose 99mTc-Tetrofosmin
Official title: Prognostic Value of Stress SPECT Myocardial Perfusion Imaging With Half Dose 99mTc-tetrofosmin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: 99mTc-tetrofosmin
myocardial perfusion imaging
SPECT
radiation
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical patients who have undergone myocardial perfusion imaging.

Brief summary: The purpose of this study is to evaluate the quality and prognostic ability of low dose 99mTc-tetrofosmin Myocardial Perfusion SPECT Imaging.

Detailed description: The objective of this study is to determine if myocardial perfusion imaging (MPI) using a new SPECT reconstruction software and a low dose (LD) of 99mTC-tetrofosmin will provide equal quality and prognostic value as a full dose (FD) of 99mTc-tetrofosmin myocardial perfusion SPECT imaging methodology.

The images of clinical patients from the Diagnostic Imaging Department will be assessed and compared for image quality and myocardial perfusion. The outcomes of participants that have had FD studies will be compared to those who have had LD studies. Consented participants will be contacted and will be asked to provide information on their cardiovascular health since the date of their LD or FD scan, such as non fatal myocardial infarction, death, congestive heart failure, admission to hospital with chest pain, further cardiac diagnostic testing, including angiography and early and late revascularization. The event information will be tabulated at 6, 12, 18, and 24 months for the LD and FD studies.

The study hypothesizes that there will be no difference in the quality and prognostic value between the LD and FD 99mTc-tetrofosmin SPECT MPI imaging protocols. The study hypothesizes that there will be no increase in repeat diagnostic testing and angiography with using the LD imaging protocol.

Eligibility criteria: Inclusion Criteria:

* Participants who have completed the FD and LD MPI studies on the GE Infinia Haweye or GE NM 530 (CZT crystal) cameras
* Retrospective participants must consent to the study interview(s) for data collection
* Prospective participants must consent to follow up for data collection

Exclusion Criteria:

* Unwilling to consent to data collection either retrospectively or in follow up prospectively

Primary outcomes:
measure: Cardiovascular Outcomes
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Insitute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Renée Hessian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03849612: A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus
Official title: An Early Feasibility Study to Evaluate Basal Initialization Parameters in an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-02-21
Enrollment: 10
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: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to evaluate whether an Automated Insulin Delivery (AID) System is safe to use and functions as intended with personalized basal insulin rates and when basal insulin rates are increased.


Eligibility criteria: Inclusion Criteria:

* Participants with T1DM for at least 2 years and who have used an insulin delivery system with any rapid-acting insulin analog for the preceding 6 months
* Have a body mass index of 18.5 to 37 kilogram per meter squared
* Have a hemoglobin A1c level ≥6.0% and ≤9.0%

Exclusion Criteria:

* Have known allergies or history of hypersensitivity to insulin lispro
* Have had an episode of severe hypoglycemia within the past 6 months
* Have had more than 1 episode of diabetic ketoacidosis in the past 6 months

Primary outcomes:
measure: Number of Adverse Events (AEs)
timeFrame: In-Patient Period (5 Days)
measure: Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL
timeFrame: In-Patient Period (5 Days)
Secondary outcomes:
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Christiansen M, Bartee A, Lalonde A, Jones RE, Katz M, Wolpert H, Brazg R. Performance of an Automated Insulin Delivery System: Results of Early Phase Feasibility Studies. Diabetes Technol Ther. 2021 Mar;23(3):187-194. doi: 10.1089/dia.2020.0318. Epub 2020 Oct 5.
Clinical trial NCT03307512: PK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD
Official title: Samba-AC: A Randomized, Open-Label, Cross-Over Study to Investigate the PK and PD Profiles of Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Healthy Subjects and Non-Diabetic Subjects With Mild to Moderate Asthma or COPD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Safety and Tolerability
Keywords: inhaled insulin
asthma
COPD
Lead sponsor: Dance Biopharm Inc.
Sponsor class: INDUSTRY
Collaborators: name: WCCT Global
First posted: 2017-10-11
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, open-label, cross-over design
Primary purpose: TREATMENT

Brief summary: This will be a randomized, open-label, active-controlled, single dose crossover study with either three or four treatment periods. Investigational treatment is with Dance 501 Human Insulin Inhalation Solution (Dance 501) and the comparator is Insulin Lispro (Humalog®).

Target population will be Non-Diabetic individuals with mild to moderate asthma or chronic obstructive pulmonary disease (COPD) and non-diabetic individuals without underlying lung disease (healthy subjects).

Detailed description: The PK and PD profile of Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be compared to subcutaneous injection of insulin lispro.

Eligibility criteria: Inclusion Criteria:

* non-diabetic subjects with asthma, or COPD. Non-smokers or smokers quit at least 6 months prior to enrollment. BMI \<= 35 kg/m2. Fasting blood glucose \<= 125 mg/dL.

Exclusion Criteria:

* pulmonary disorder other than asthma or COPD. Upper respiratory within previous 4 weeks. Significant exacerbation of asthma or COPD symptoms. Hospitalization for asthma or COPD within previous 3 months. Clinically significant medical condition. Current medications interfering with glucose metabolism.

Primary outcomes:
measure: Area under the insulin curve (AUC)
timeFrame: 10 hours
measure: Area under the glucose infusion rate curve (GIR)
timeFrame: 10 hours
Secondary outcomes:
measure: Area under the insulin curve following inhalation of salbutamol
timeFrame: 10 hours
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT
state: California
Study officials:
affiliation: AMCR
name: Timothy S Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06983912: Preoperative Rehabilitation Training and Total Knee Arthroplasty Outcomes
Official title: The Effect of Preoperative Rehabilitation on Functional Recovery After Total Knee Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis of Knee
Lead sponsor: Fuzhou University Affiliated Provincial Hospital
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Joint replacement surgery is an effective treatment for severe joint diseases, but the postoperative recovery process is complex and lengthy. Preoperative rehabilitation training, as an important part of preoperative preparation, has been proven to significantly improve postoperative recovery outcomes. However, there is currently a lack of systematic research on the optimal protocols and duration of preoperative rehabilitation training and their specific impacts on postoperative recovery. This study aims to evaluate the effects of preoperative rehabilitation training on postoperative recovery after joint replacement through a randomized controlled trial, providing scientific evidence for clinical practice.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis is osteoarthritis and Scheduled for joint replacement surgery.
2. Age ≥18 years old and ≤90 years old, with no gender restrictions.
3. Patients voluntarily participate in the study and sign the informed consent form.

Exclusion Criteria:

1. Severe cardiopulmonary insufficiency, unable to tolerate rehabilitation training.
2. Neurological disorders leading to motor dysfunction.
3. Mental illnesses that prevent cooperation with rehabilitation training.
4. Severe joint deformities or muscle atrophy present before surgery, affecting the implementation of rehabilitation training.

Primary outcomes:
measure: Knee Joint Function Assessment
timeFrame: Following total knee arthroplasty, assessments are typically conducted at the 1st, 3rd, 6th, and 12th month post-surgery
Secondary outcomes:
measure: Postoperative Assessment
timeFrame: Following total knee arthroplasty, assessments are typically conducted at the 1st, 3rd, 6th, and 12th month post-surgery.
Other outcomes:
Locations:
Study officials:
References: