louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01577238: A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
Official title: A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Assess the Efficacy and Safety of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Vaginosis
Keywords: SPL7013
VivaGel
bacterial vaginosis
BV
Lead sponsor: Starpharma Pty Ltd
Sponsor class: INDUSTRY
First posted: 2012-04-13
Enrollment: 250
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV).

After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30).


Eligibility criteria: Key eligibility criteria:

* Post-menarchal females, aged 12 years or more
* Diagnosis of BV by Amsel criteria (ie all four of the following signs/symptoms: presence of white to grey homogeneous discharge; positive whiff test indicating an amine (fishy) odor with addition of potassium hydroxide; vaginal pH greater than 4.5; and presence at least 20% clue cells of total epithelial cells
* Nugent score of at least 4
* Otherwise healthy, as determined by medical history, physical examination
* normal Pap smear at or documented within 24 months of screening

Primary outcomes:
measure: Number of Women With Clinical Cure at the End of Treatment Visit (EOT)
timeFrame: Day 9-12
Secondary outcomes:
measure: Number of Women With Nugent Cure at the EOT Visit
timeFrame: Day 9-12
measure: Number of Women With Clinical Cure at the Test of Cure Visit (TOC)
timeFrame: Day 21-30
measure: Number of Women With Nugent Cure at the TOC Visit
timeFrame: Day 21-30
measure: Adverse Events Potentially Related to Treatment
timeFrame: Screening/baseline through TOC visit, Day 1-30
Other outcomes:
Locations:
Study officials:
affiliation: Starpharma Pty Ltd
name: Jeremy Paull, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00396838: Cardiac Autonomic Reactivity and Behavioral Response to Pain in Full-Term Neonates
Official title: Cardiac Autonomic Reactivity and Behavioral Response to Pain in Full-Term Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2006-11-08
Enrollment: 300
Sex: ALL
Minimum age (years): 48
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Background: Heel lancing is a routine procedure for the diagnosis of phenylketonuria in infants. Despite the short- and long-term adverse effects of pain, there are no guidelines for the reduction of such pain. Previous studies evaluated different treatment modalities; however, in most of them, pain response was assessed by subjective measures.

Aims of study: 1. To characterize the pain response of infants by using a computerized analysis of the ECG. 2. To compare six different methods of pain reduction during heel lancing in newborns.

Methods: The time, geometric and frequency domains of the infants' ECG will be computed during heel lancing. 150 healthy full-term infants will be evaluated in six treatment groups: breastfeeding, bottle feeding, skin-to-skin contact, lying on a table without anything, lying with a pacifier and lying while getting a glucose solution. The differences in pain response to these six treatment modalities will be assessed and compared to the infants' length of cry, and scoring of the infants' behavioral response.


Eligibility criteria: Inclusion Criteria:

* normal full-term newborns (\>38 weeks)
* Apgar score \>=8 at five minutes after delivery.

Exclusion Criteria:

* congenital anomalies
* medical complications
* need for oxygen administration

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam MC
Study officials:
affiliation: Rambam MC
name: Amir Weissman, MD
role: STUDY_DIRECTOR
References:
citation: Weissman A, Aranovitch M, Blazer S, Zimmer EZ. Heel-lancing in newborns: behavioral and spectral analysis assessment of pain control methods. Pediatrics. 2009 Nov;124(5):e921-6. doi: 10.1542/peds.2009-0598. Epub 2009 Oct 19.
Clinical trial NCT05529238: Kegel Exercises for Stress Urinary Incontinence
Official title: Effectiveness of Supervised Kegel Exercises Using Bio-feedback Versus Unsupervised Kegel Exercises on Stress Urinary Incontinence: A Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence,Stress
Lead sponsor: Charles Darwin University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study about a targeted group of women suffering from self-reported stress urinary incontinence, attend a Kegel exercise training program. The group was divided into two; supervised and unsupervised. Whilst both groups benefited from initially seeing a women's health physiotherapist for a pelvic floor muscle assessment and a bespoke Kegel exercise program, only the supervised group continued to see the physiotherapist for monthly bio-feedback training. The unsupervised group relied on their own motivation to perform their Kegel exercises as prescribed. At the end of the twelve week program, both groups had a final pelvic floor muscle strength assessment by the physiotherapist to determine any changes and subsequent improvements in urinary incontinence.

Aim : Investigate and compare the efficacy of supervised Kegel exercises with biofeedback on Stress Urinary Incontinence (SUI) and Pelvic Floor Muscle Strength (PFMS) compared to unsupervised Kegel exercises.

The primary goal of this study was to determine the effectiveness of supervised Kegel exercises using BT versus unsupervised Kegel exercises without biofeedback training, on SUI. A secondary outcome was to establish whether an improvement was observed in PFMS and subsequently, the effect of this on SUI. It was hypothesized that regular support and visual motivation and direction of BT from the physiotherapist, would provide greater results.


Eligibility criteria: Inclusion Criteria:

* being female
* aged over 18 years
* suffer from SUI (their subjective disclosure was based on a description provided for their reference)
* did not perform Kegel exercises
* be available for duration of 12-week program

Exclusion Criteria:

* pregnancy and breastfeeding

Primary outcomes:
measure: Incontinence severity index (ISI) tool
timeFrame: Week 0
measure: Incontinence severity (ISI) index tool
timeFrame: Week 12
measure: Pelvic floor assessment from physiotherapist
timeFrame: week 0
measure: Pelvic floor assessment from physiotherapist
timeFrame: week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Darwin
country: Australia
facility: Charles Darwin University
state: Northern Territory
Study officials:
References:
Clinical trial NCT02298738: Effect of Vit D on New-onset AF in Hypertension
Official title: Relation of Low Vitamin D Levels and New-onset AF Among Hypertensive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Hypertension
Keywords: Atrial fibrillation, hypertension, vitamin D
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertensive patients with new-onset AF. New onset AF was defined as AF identified for the first time by an electrocardiogram or ambulatory holter monitoring. Hypertension was defined as blood pressure ≥ 140/90 mmHg or a history of antihypertensive drug use.

Brief summary: Atrial fibrillation (AF), an important cause of cardiac mortality and morbidity is the most common type of cardiac arrhythmia in clinical practice. Hypertensive individuals are at particular risk of development of atrial fibrillation. Renin-angiotensin-aldosteron system (RAS) which is activated in hypertension may be the underlying mechanism of AF among hypertensive patients.

Vitamin D deficiency has been shown to be involved in the pathogenesis of hypertension, cardiovascular disease and obesity. Increased RAS activity is one of the postulated mechanisms by which vitamin D deficiency may trigger the development of hypertension and various cardiovascular diseases. On the basis of these data we hypothesized that hypovitaminosis D might be associated with new-onset AF among patients with hypertension.


Eligibility criteria: Inclusion Criteria:

* Hypertensive patients with new-onset AF

Exclusion Criteria:

Established coronary artery disease

* Heart failure
* Chronic obstructive pulmonary disease
* Diabetes mellitus
* Significant heart valve disease
* Hyperthyroidism
* Renal failure
* Any malignancy
* Acute infection
* Recent thoracic or abdominal surgery
* Under therapy of Vit D3

Primary outcomes:
measure: hypovitaminosis D
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01086943: Clinical Safety Study on an Eyelid Warming Device to Evaluate the Eyelid and Cornea Temperature in Healthy Volunteers
Official title: Clinical Safety Study on an Eyelid Warming Device, Moist Heat Technology BLEPHASTEAM®, to Evaluate the Eyelid and Cornea Temperature in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Eyelid Diseases
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2010-03-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in the eyelids.

Prospective, non comparative, open, monocentre study.

The objectives are:

* To verify and establish the temperature of the eyelids and cornea for each eye before and after 10 minutes device application
* To evaluate the ocular surface, NIBUT and IOP before and after device application
* To determine the acceptability of healthy volunteers on the practical use of this device

The subjects will attend 2 visits.


Eligibility criteria: Inclusion Criteria:

* Male or female aged from 18 to 80 years old.
* Healthy volunteers.
* For any contact lens wearers, they must be wearing hydrogel contact lenses (worn at least 3 times per week)
* Normal ocular examination in both eyes.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: School of Optometry & Vision Sciences
Study officials:
affiliation: Cardiff University
name: Christine Purslow
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00726843: Evaluation of Yoga for the Treatment of Pediatric Headaches
Official title: Evaluation of Yoga for the Treatment of Pediatric Headaches
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Headache
Keywords: Headache
Complementary and Alternative Medicine
Pediatric
Yoga
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Health System Foundation, Wisconsin
name: Santosh Yoga LLC
First posted: 2008-08-01
Enrollment: 7
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will examine the feasibility and acceptability of yoga for adolescents seen by a medical practitioner for their headaches. The study will also examine whether yoga decreases anxiety and improves quality of life. We hypothesize that yoga will be both acceptable and feasible with a pediatric population. We also hypothesize that yoga will decrease anxiety and improve quality of life.


Eligibility criteria: Inclusion Criteria:

* 13-17 years
* patient seen in the headache clinic at Children's Hospital of Wisconsin

Exclusion Criteria:

* neck, spinal, or back injuries

Primary outcomes:
measure: Headache Pain
timeFrame: Pre; Post; Weekly
Secondary outcomes:
measure: Yoga Attendance
timeFrame: weekly
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Keri R Hainsworth, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00581243: Study Evaluating Safety and Tolerability of Ascending Multiple Dose of SLV-313 in Schizophrenia Patients
Official title: An Ascending Multiple-Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SLV-313 Sustained-Release (SR) Tablets Administered Orally to Subjects With Schizophrenia and Schizoaffective Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety,Tolerability, Schizophrenia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Solvay Pharmaceuticals
First posted: 2007-12-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Randomized, inpatient, ascending multiple dose study given to subjects with schizophrenia and schizoaffective disorder to assess safety and tolerability.


Eligibility criteria: Inclusion Criteria:

* Men, aged 18-50 years old
* Women, aged 18-50 years old

Exclusion Criteria:

* Non-lactating women, aged 18-50 years old
* Non-pregnant women, aged 18-50 years old

Primary outcomes:
measure: Observe safety and tolerability
timeFrame: 25 days
Secondary outcomes:
measure: PK and PD profile
timeFrame: 25 days
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05989243: Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation
Official title: Improving Socket Fit in Female and Male Veterans With Transtibial and TransfemoralAmputation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transtibial Amputation
Transfemoral Amputation
Keywords: Biomechanics
Kinematics
Walking
Prostheses
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 Veterans with unilateral transtibial amputation and 20 Veterans with unilateral transfemoral amputation

Brief summary: The investigators do not yet know how a prosthetic socket with adjustable panels affects the performance of people with a lower limb amputation compared to a conventional prosthetic socket. The primary objective of this study is to compare an adjustable and conventional prosthetic socket and use this information to determine the optimal socket that would improve rehabilitation and function in people with lower limb amputation.

Detailed description: The purpose of the project is to determine the effects of using different prosthetic socket designs with the same suspension and components on the biomechanical asymmetry, residual limb movement within the socket (socket pistoning) and comfort/satisfaction of 20 Veterans with a transtibial amputation and 20 Veterans with a transfemoral amputation, 10 males and 10 females per group.

Eligibility criteria: Inclusion Criteria:

* The investigators will enroll up to 40 Veterans

  * 20 with unilateral transtibial amputation
  * 20 with unilateral transfemoral amputation who are at or above a K2 Medicare functional classification level (MFCL) and who are 18-65 years old
* All participants will have no current problems with their prosthesis or residual limb, and be at least 6-months post-amputation
* Participants will be at or above a K2 MFCL, defined as a person who has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs, or uneven surfaces, typical of the limited community ambulator

Exclusion Criteria:

* Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an assistive device for their unaffected leg (i.e. orthosis, cane)

Primary outcomes:
measure: Biomechanical Asymmetry
timeFrame: through study completion, an average of 4 years
measure: Prosthetic Evaluation Questionnaire
timeFrame: through study completion, an average of 4 years
Secondary outcomes:
measure: Socket pistoning
timeFrame: through study completion, an average of 4 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Alena Grabowski, PhD BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04680143: Systemic Erythropoietin Injection in Patients Having Optic Atrophy
Official title: Systemic Erythropoietin Injection in Patients Having Optic Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Optic Atrophy
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study included 10 patients diagnosed as post papilledemic optic atrophy that were attending Alexandria main university hospital. All patients underwent initially assessment of visual acuity, color vision, pupil reaction ,funduscopy and electrophysiological tests ( pattern visual evoked potential and pattern electroretinogram in both eyes to use data of the normal fellow eye as patients' internal control). Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days). Follow up after one month and three months by recording visual acuity and electro physiological studies.
Primary purpose: TREATMENT

Brief summary: The purpose of this treatment trial is to study the effect of systemic erythropoietin in patients having optic atrophy.

Detailed description: The purpose of this treatment trial is to study the effect of systemic erythropoietin in patients having optic atrophy. The intervention is systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).

Follow up after one month and three months by recording visual acuity and electro physiological studies.

Eligibility criteria: Inclusion Criteria:

* Post papilledemic optic atrophy patients

Exclusion Criteria:

* Refuse to give an informed consent

Primary outcomes:
measure: Visual acuity
timeFrame: 3 months
measure: Pattern visual evoked Potential .
timeFrame: 3 months
measure: Pattern electroretinogram
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Medicine
Study officials:
affiliation: Alexandria Faculty of Medicine
name: Mai ElBahwash, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06450743: Age-matched Reference Values for Circulating Natural Killer T-like Cells
Official title: Age-matched Reference Values for Circulating Natural Killer t (NKT)-Like Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Lymphocytes
NKT-like cells
Reference Values
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Few data are so far available regarding the adult normal values of circulating NKT-like cell concentration, and none for the pediatric population. The primary objective of this study is to determine the reference values for NKT-like cells in pediatric and adult patients (derivation cohort). The secondary objective is to validate the results obtained from the adult derivation cohort with those obtained from an adult validation cohort, consisting of a group of healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy blood donor
* without acute or chronic pathological conditions
* matched for sex and age with the retrospective adult derivation cohort

Exclusion Criteria:

* a history of immunological or hematological diseases, immunosuppressive or immunostimulant therapies, or ongoing infections
* one of the lymphocyte subpopulations tested out of range
* undergoing surgery or dentistry intervention in the past two months

Primary outcomes:
measure: NKT-like cells reference values determination (absolute number and percentage) from the derivation cohort
timeFrame: 2 months
Secondary outcomes:
measure: NKT-like cells reference values validation (absolute number and percentage) using healthy blood donors (>16 years)
timeFrame: 1 month
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
state: MI
Study officials:
affiliation: Flow Cytometry Laboratory, Clinical Pathology
name: Elena Trombetta, BSc
role: PRINCIPAL_INVESTIGATOR
References: