louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01437722: Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)
Official title: A Double-blind, Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally to Prevent the Recurrence of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Bacterial Vaginosis (BV)
Keywords: BV
Bacterial vaginosis
recurrent
SPL7013 Gel
VivaGel
Lead sponsor: Starpharma Pty Ltd
Sponsor class: INDUSTRY
First posted: 2011-09-21
Enrollment: 205
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.


Eligibility criteria: Inclusion Criteria:

* Women aged 18-45 years with a history of recurrent BV, defined as at least 3 documented episodes in the previous 12 months (including the current episode).
* Current episode of BV as defined by subject-reported symptoms and Amsel's Criteria
* Otherwise healthy

Exclusion Criteria:

* No active STIs and/or current UTI
* Previous exposure to SPL7013 Gel
* A Papanicolaou (Pap) smear result considered to be clinically significant (ie, high grade cervical intraepithelial squamous lesions \[HSIL\] on cytology or cervical intraepithelial neoplasia \[CIN\] grades of CIN2 or CIN3 on histology) in the previous 2 years or in accordance with local treatment guidelines.

Primary outcomes:
measure: Number of women who have experienced a recurrent episode of BV as a measure of efficacy
timeFrame: Day 112 +/- 5
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Starpharma Pty Ltd
name: Jeremy Paull, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05930522: Psychomotor Performance of Preterm Infants
Official title: Psychomotor Performance of Preterm Infants Born Between 24 and 35 Weeks of Gestation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychomotor Development Impaired
Keywords: Preterm Birth
Preterm Infant
Motor abilities
Eurofit
Vienna test
Postural stability
Lead sponsor: Gdansk University of Physical Education and Sport
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 180
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 180 healthy school children

Brief summary: The first part involved 120 children in grades II and III of elementary schools. From this group, children were qualified for the second part of the study - 35 randomly selected children born on time (BoT) and 35 children born before 35 weeks of pregnancy (PB). EUROFIT tests, Vienna Tests and postural stability tests were carried out in both groups.


Eligibility criteria: Inclusion Criteria:

* preterm born (PB): born before 35 weeks of gestation
* both groups: aged 7-9 y during the research project

Exclusion Criteria:

* musculoskeletal injuries
* neurological disorders or other CNS damage

Primary outcomes:
measure: Eurofit test
timeFrame: 20 minutes
measure: Biodex Balance System SD
timeFrame: 15 minutes
measure: Vienna Test
timeFrame: 15 min minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Gdansk University of Physical Education and Sport
state: Pomorskie
Study officials:
affiliation: Gdansk University of Physical Education and Sport
name: Paulina Ewertowska, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06213922: Prevalence of and Risk Factors of Obesity in School Children and Adolescents in Nag Hammadi City. 300 Participants.
Official title: Prevalence of and Risk Factors of Obesity in School Children and Adolescents in Nag Hammadi City.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obesity, Adolescent
Keywords: Body mass index
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Community study

Brief summary: Searching for obese children who's body mass index is above normal range and risk factors in children and adolescents in Nag Hammadi city


Eligibility criteria: Inclusion Criteria:

* children and adolescents 12to18years.

Exclusion Criteria:

* children younger than12 years and who have special conditions as deaf.

Primary outcomes:
measure: Change in dietary habits
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06730022: Dermacyte® Liquid for Treatment of Cutaneous Ulcers and Wounds
Official title: Dermacyte® Liquid for Treatment of Cutaneous Ulcers and Wounds
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Cutaneous Ulcer
Diabetic Ulcer
Surgical Wound Dehiscence
Burns - Multiple
Pressure Ulcers
Mixed Ulcer
Ischemic Ulcer
Lead sponsor: Merakris Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-12-12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The objective of this study is to make Dermacyte Liquid available on an expanded access basis to treat cutaneous ulcers and wounds refractory to initial treatment or that do not have adequate alternative treatments. Minimal data will be collected to evaluate the efficacy and safety of Dermacyte Liquid.

Detailed description: The primary purpose is to provide expanded access of Dermacyte Liquid to subjects who have serious cutaneous ulcers and wounds (e.g., ulcers related to diabetes mellitus, venous insufficiency, complications of systemic sclerosis or rheumatic disease; decubitus ulcers, burns, acute trauma, wound dehiscence, ischemic ulcers, and mixed etiology ulcers). Eligible subjects must have a high likelihood of significant morbidity, loss of quality of life, potential amputation, or mortality without efficacious treatment. As there are many types of patients who may be enrolled, study results will not have statistical significance.

Eligibility criteria: Inclusion Criteria:

* Must be 18 years of age or older
* Must have a cutaneous ulcer or wound refractory to initial treatment or does not have an adequate treatment alternative, as determined by the Investigator

Exclusion Criteria:

* Must not be pregnant or lactating
* Must not have known malignancies
* Must not be less than 18 years of age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Arvada
country: United States
facility: The WISH Clinic
state: Colorado
Study officials:
References:
Clinical trial NCT00816322: The Effect of Fish Oil in Major Depressive Disorder
Official title: The Effect of Fish Oil in Major Depressive Disorder: a Double-blind Placebo-controlled Monotherapy Trail and a RCT for Recurrence Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: National Science and Technology Council, Taiwan
Sponsor class: OTHER_GOV
First posted: 2009-01-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The whole study was divided into two major parts: (A) the 12-week, double-blind, randomized controlled, parallel omega-3 fatty acid monotherapy study in 60 patients with mild to moderate major depressive disorder. (B) The double-blind, randomized controlled, parallel omega-3 fatty acid add-on prevention study in 60 patients with major depressive disorder in recovery status.

The goals of this study were to examine the therapeutic and recurrence prevention effects of omega-3 fatty acids on major depressive disorder.


Eligibility criteria: Inclusion Criteria:

1. DSM-IV criteria for major depressive disorder.
2. Age being age 18-65.
3. Capacity and willingness to give written informed consent.

Exclusion Criteria:

1. Any major medical illnesses.
2. A recent or past history of any Axis-I diagnoses besides major depressive disorder, including psychotic disorders; cognitively impaired mental disorders; impulse control disorders; substance use disorder or substance abuse (last 6 months prior to the studies); primary anxiety disorders, including post-traumatic stress disorder and panic disorder; and bipolar disorders; or Axis-II diagnoses, i.e. borderline and antisocial personality disorder.

Primary outcomes:
measure: HAMD
timeFrame: W0 W2 W4 W8 W12
Secondary outcomes:
measure: BDI
timeFrame: W0 W2 W4 W8 W12
measure: Adverse effects
timeFrame: W0 W2 W4 W8 W12
measure: Recurrence rate
timeFrame: M0 M1 M2 M3 M4 M6
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
References:
citation: Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
Clinical trial NCT01298622: The Imaging Genetic Study of the Core Family of Obsessive-compulsive Disorder (OCD) Patient
Official title: The Study of Structural and Functional Brain Abnormalities and the Association With the Genetic Polymorphism in the Core Family of OCD Patient
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: OCD
Lead sponsor: Kunming Medical University
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: OCD patients and their parents

Brief summary: To investigate the structural/functional abnormalities and the possible genetic endophenotypes of Obsessive-compulsive disorder (OCD) patients and their core families.


Eligibility criteria: Inclusion Criteria:

* diagnosed OCD patient

Exclusion Criteria:

* organic disease
* other psychiatric disorder

Primary outcomes:
measure: Y-BOCS
timeFrame: Y-BOCS
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: Psychiatry department of KMC
state: Yunnan
Study officials:
affiliation: the 1st affiliated hospital of Kunming medical college
name: Xiufeng Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05167422: Trusted Messenger Intervention
Official title: Preliminary Study of a Trusted Messenger Intervention to Promote Vaccine Uptake in Adult Inpatient Psychiatric Hospitals
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vaccine Hesitancy
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Nested quasi-experimental
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this pilot study is to develop and evaluate test a trusted messenger intervention targeting vaccine hesitancy in patients on an inpatient psychiatric hospital setting with both acute and chronic patients.


Eligibility criteria: Inclusion Criteria:

* Able and willing to give verbal informed consent to participate in the study or able to assent with guardian consent
* Expected to remain in the hospital for the duration of the study
* Mental health diagnosis Demographics
* Male, female, or transgender (no exclusion criteria based on gender or sexual orientation)
* Ages 18 or older
* Any race or ethnicity
* English speaking

Exclusion Criteria:

* Cognitive impairment sufficient to interfere with participant's ability to provide assent
* People who are non-English speakers or who have major visual or hearing impairment will be excluded given the need to converse with the Trusted Messenger verbally
* People who have received any of the available forms of the COVID-19 vaccine, or those with a medical exemption for receiving the vaccine.

Primary outcomes:
measure: Vaccine acceptance- This will be measured using the COVID Vaccine Hesitancy Questionnaire
timeFrame: Participant is willing to receive the vaccine by the end of week 6 of participation from baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Concord
country: United States
facility: New Hampshire Hospital
state: New Hampshire
Study officials:
References:
Clinical trial NCT07012122: Effect of Disturbed Attention on Balance in Children With Spastic Cerebral Palsy
Official title: Effect of Disturbed Attention on Balance in Children With Spastic Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Spastic Cerebral Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 63
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sixty-three children with diplegic Cerebral Palsy of both genders that will be selected from Outpatient Clinic of Faculty of Physical Therapy, Cairo University.

Brief summary: The purpose of the current study is to determine if there is a correlation between disturbed attention and balance in children with spastic diplegia.

Detailed description: The neuromuscular impairments in children with CP are manifested in abnormal posture and loss of selective motor control, poor trunk control and balance which contributes to poor postural control with significant limitations in their activities of daily living. Balance and upright postural control are fundamental components of movement which plays a major role in maintaining the body in equilibrium in a given sensory environment, with anticipatory and automatic postural adjustments. So, improving balance abilities in such children is fundamental.

In general, attention involves processes that allow individuals to focus on particular aspects of the environment and to mobilize sufficient effort for learning and problem solving.

Children with diplegic CP encounter difficulties in sensory processing and integration which influence the achievement of mature postural control.

There is reviews that didn't cover the relation between attention and balance. This study is to improve evidence regarding this area.

Eligibility criteria: Inclusion Criteria:

* Cerebral palsy children with spastic diplegia.
* Age ranges from 8 -12 years.
* Level Ι - II according to Gross Motor Functional Classification System (GMFCS).
* Grade 1, 1+ of the Modified Ashworth Scale.

Exclusion Criteria:

* Children that suffer from epilepsy.
* Severe visual and auditory problems.
* Structural or fixed soft tissue deformities of Lower extremities.
* Severe mental retardation.
* Botox injection in the lower extremity in the past 6 months.

Primary outcomes:
measure: Overall stability index (OSI)
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Assistant Professor, Cairo university
name: Asmaa Osama Sayed, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03637322: Evaluation of Implementation of the Phoenix PrEP (Pre-Exposure Prophylaxis) Access Project for Youth Aged 13-24
Official title: Evaluation of Implementation of the Phoenix PrEP Access Project for Youth Aged 13-24
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unsafe Sex
IV Drug Usage
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 42
Sex: ALL
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Youth aged 13 through 24 in the Phoenix area who are high risk for HIV infections because of unsafe sex practices and or IV drug use and have been offered PrEP as part of their standard medical care.

Brief summary: This study will evaluate the implementation of a PrEP program for youth aged 13-24 in Phoenix, AZ. Numbers of youth who initiate PrEP, how long they continue with PrEP, and the barriers for youth who are trying to initiate and continue taking PrEP will be examined.

Detailed description: This observational study will describe the barriers encountered and the benefits found as youth engage in a PrEP program, the Phoenix PrEP Access Project and as they participate in PrEP provided through standard medical care. This study does not investigate the safety, efficacy or other medical benefits of PrEP, but looks at the issues surrounding youth who are trying to access PrEP.

Eligibility criteria: Inclusion Criteria

* sexually active youth aged 13 through 24,
* at risk for contracting HIV,
* Negative for HIV as indicated by Negative Elisa and Western Blot (WB) or Negative 4th Generation test,
* weight greater than 35kg,
* offered PrEP to reduce the risk of contracting HIV.

Exclusion Criteria

* Unknown or Positive HIV status,
* Renal Impairment as indicated by elevated BUN or Creatinine, abnormal urinalysis,
* Active infection with Hepatitis B Virus,
* Taking other medications containing Emtricitabine, Tenofovir or tenofovir alafenamide(TAF) such as Atripla, Complera, Emtriva, Genvoya, Odefsey, Stribild, and Viread taking drugs containing lamivudine,
* taking Hepsera,
* clinical symptoms consistent with acute viral infection within the past month.

Primary outcomes:
measure: PrEP Uptake
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital, Bill Holt Clinic
state: Arizona
Study officials:
affiliation: Phoenix Children's Hospital
name: Janice Piatt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04061122: The Role of Congenital Mucosal Immune System in the Airways of Patients With Chronic Obstructive Pulmonary Disease
Official title: The Role of Congenital Mucosal Immune System in the Airways of Patients With COPD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD Exacerbation
Smoking, Tobacco
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: EX (COPD exacerbation) TS (tobacco smoking)

Group: EX + / TS + Patients suffering COPD exacerbation in last 7 days; active tobacco smokers

Group: EX - / TS + Patients without COPD exacerbation in last 6 months; active tobacco smokers

Group: EX + / TS - Patients suffering COPD exacerbation in last 7 days; smoking was stopped a minimum of 12 months before the first visit

Group: EX - / TS - Patients without COPD exacerbation in last 6 months; smoking was stopped a minimum of 12 months before the first visit

Brief summary: The purpose of the study is to explore the role of congenital mucosal immune system in the airways of patients with COPD including the impact of ILCs (Innate lymphoid cells) on metabolism of epithelial cells.During the research the following methods will be applied: measurement of Volatile Organic Compounds (VOCS), airway epithelial cytology and culture.

Detailed description: ILCs profiles, epithelium metabolism measured by VOCS and microbiome profiling (specific 16S rRNA-16S ribosomal RNA gene-targeted qPCR) will by determined in the airways of patients with COPD after the exacerbation. Microbiome profiling will be based on next generation sequencing (NGS) of the 16S rRNA encoding region.

Eligibility criteria: Exclusion Criteria:

* Neoplasm
* Diabetes
* Astma
* acute airway infection in last 2 weeks

Primary outcomes:
measure: percentage of nasal ILCs (Innate lymphoid cells) after COPD exacerbation
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland
Study officials:
References:
Clinical trial NCT06848322: The Effects of 8-week Resistance and Aerobic Exercise on Anxiety, Depression, Sleep, Inhibitory Control in Young Adults With Smartphone Overdependence
Official title: The Effects of 8-week Resistance and Aerobic Exercise on Anxiety, Depression, Sleep, Inhibitory Control in Young Adults With Smartphone Overdependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Smartphone Addiction
Sleep
Inhibition
Mood
Lead sponsor: University of Seoul
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: resistance exercise group → Experimental aerobic exercise group → Experimental control → No Intervention There are three groups in this study: the resistance exercise group, the aerobic exercise group, and the control group. Measurements are conducted at three time points: pre-intervention, mid-intervention (4 weeks after the intervention), and post-intervention
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to identify the effects of the resistance exercise and aerobic exercise on depression, anxiety, sleep, inhibitory control in young adult with smartphone overdependence


Eligibility criteria: Inclusion Criteria:

* Smartphone overdependent scale score of 24 ≥
* No regular exercise in the past 3 months

Exclusion Criteria:

* Unable to perform exercise
* Patients with musculoskeletal disorders
* Patients with cardiovascular diseases.

Primary outcomes:
measure: sleep duration
timeFrame: pre intervention: for 8days(before the intervention) / post intervention: for 8days(after the intervention)
measure: Sleep efficiency
timeFrame: pre intervention: for 8days(before the intervention) / post intervention: for 8days(after the intervention)
measure: Time in bed
timeFrame: pre intervention: for 8days(before the intervention) / post intervention: for 8days(after the intervention)
measure: Sleep onset time
timeFrame: pre intervention: for 8days(before the intervention) / post intervention: for 8days(after the intervention)
measure: wake time
timeFrame: pre intervention: for 8days(before the intervention) / post intervention: for 8days(after the intervention)
Secondary outcomes:
measure: Depression
timeFrame: pre intervention(day 1), post intervention(day 57)
measure: Anxiety
timeFrame: pre intervention(day 1), post intervention(day 57)
measure: Inhibition
timeFrame: pre intervention(day 1), post intervention(day 57)
Other outcomes:
Locations:
city: Dongdaemun
country: Korea, Republic of
facility: University of Seoul, Centennial Memorial Hall.
state: Seoul
Study officials:
References: