louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03559595: Increasing PrEP Among African Americans in Louisville KY
Official title: Increasing Pre-exposure Prophylaxis Among High-Risk African Americans in Louisville KY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS PREVENTION
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study evaluates the effectiveness of a multifaceted strategy to increase pre-exposure prophylaxis (PrEP; a medication regimen to reduce HIV risk) uptake among high risk African Americans in Louisville, KY. We will do this by 1) implementing a media campaign to raise awareness about PrEP, 2) providing PrEP education to medical personnel who can prescribe PrEP, and 3) partnering with AIDS service organizations to improve outreach and linkage to PrEP services.


Eligibility criteria: Inclusion Criteria:

* Between ages 18-29 years old
* Self-identifies as African American or Black
* Resident of Louisville, KY
* Member of a priority group for PrEP HIV prevention (Men who have sex with men, people who inject drugs, trans women, high risk heterosexuals, people in serodiscordant relationships).
* Not diagnosed with HIV

Exclusion Criteria:

* Older than 29 and younger than 18 years old
* Does not identify as African American or Black
* Does not reside in Louisville, KY
* Not a member of a priority group
* Diagnosed with HIV

Primary outcomes:
measure: PrEP uptake
timeFrame: 12 months
Secondary outcomes:
measure: PrEP intentions
timeFrame: 12 months
measure: PrEP prescription
timeFrame: 12 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
References:
Clinical trial NCT06216795: Kidney Volume in Live Donors Kidney Transplant Donors and Recipients
Official title: Measurement of Kidney Volume Using Computed Tomography in Kidney Transplant Donors and Recipients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplant; Complications
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Severance Hospital
First posted: 2024-01-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: live kidney donors and paired their recipients.

Brief summary: The investigators aim to investigate the association between renal volume measured through pre-donation CT auto-segmentation and postoperative renal function of both donors and recipients. After establishing the statistical significance of the association, the investigators intend to create and validate predictive models for renal function at surgery, 1 year, and 3 years postoperatively, incorporating various factors known to contribute to renal function deterioration.


Eligibility criteria: Inclusion Criteria:

* live donor kidney transplant

Exclusion Criteria:

* donors without preoperative enhanced CT image

Primary outcomes:
measure: Prediction models for the residual renal function of donors and the graft kidney function of recipient after live donor kidney transplantation
timeFrame: 1 and 3 years after transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01597895: Estimate the Effect of Telaprevir and Boceprevir on Maraviroc Pharmacokinetics in Healthy Subjects
Official title: Open-Label, Randomized, Fixed-Sequence, Crossover Study to Estimate the Effect of Telaprevir and Boceprevir on Maraviroc Pharmacokinetics in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: maraviroc
boceprevir
telaprevir
drug interaction
pharmacokinetics
HIV
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2012-05-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effect that telaprevir and boceprevir has on the pharmacokinetics of maraviroc.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
* Total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
* Positive result for HIV-1, HIV-2, Hepatitis B serology (HbsAg, HbcAb) or anti hepatitis C virus serology (as determined by a multi antigen EIA).

Primary outcomes:
measure: Maraviroc plasma pharmacokinetic parameters: AUC12, Cmax, and C12h on Period 1, Day 5 and Periods 2 and 3, Day 10
timeFrame: 25 days
Secondary outcomes:
measure: Maraviroc plasma pharmacokinetic parameters: Tmax on Period 1, Day 5 and Periods 2 and 3, Day 10
timeFrame: 25 days
measure: Boceprevir plasma pharmacokinetic parameters: AUC8, Cmax, C8h, and Tmax on Period 2, Day 10
timeFrame: 10 days
measure: Telaprevir plasma pharmacokinetic parameters: AUC8, Cmax, C8h, and Tmax on Period 3, Day 10
timeFrame: 10 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05343195: Balance and Leg Function After Hip Replacement
Official title: Effect of Task-Specific Exercise on Balance and Leg Function in Patients After Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Injuries
Coxarthrosis
Hip Replacement
Keywords: balance
hip function
hip replacement
elderly
physical functioning
Lead sponsor: Lithuanian Sports University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Task-oriented leg exercise are commonly used after joint surgeries in various hip pathologies. Based on this theory, it was hypothesized that task-oriented exercise without conventional physiotherapy can have better result in recovery of balance and leg function than with a conventional post-hip physiotherapy program after hip replacement surgery. The aim of the study was to determine the effect of task-oriented exercise on balance and leg function after total hip replacement.

Detailed description: Study included 40 subjects. All subjects were randomly divided into control and intervention groups. VAS scale was used to assess the pain, hip range of motion were measured using a goniometer, strength of the muscles was assessed on the Oxford 5 point scale, leg function was evaluated with modified Harris hip scale, Abili balance analyzer was used to assess static balance and Berg balance scale was used to measure dynamic balance. Intervention duration was 18 days.

Eligibility criteria: Inclusion Criteria:

* BMI \< 40;
* Hip coxarthrosis;
* Hip total replacement;
* Posterior incision;
* Surgery performed no more than 1 week ago;
* Ability to comprehend and execute the tasks.

Exclusion Criteria:

* Revision surgery;
* Surgery intervention for other reasons (fracture, arthritis);
* Severe cardiovascular disease;
* Vestibular disorders;
* Vision disorders;
* Proprioception disorders;
* Neurological disorders.

Primary outcomes:
measure: Change from baseline Pain at 18 days
timeFrame: Baseline and after 18 days
measure: Change from baseline Hip range of motions at 18 days
timeFrame: Baseline and after 18 days
measure: Change from baseline Hip Muscle Strength at 18 days
timeFrame: Baseline and after 18 days
measure: Change from baseline Leg Function at 18 days
timeFrame: Baseline and after 18 days
measure: Change from baseline Dynamic Balance at 18 days
timeFrame: Baseline and after 18 days
measure: Change from baseline Static Balance at 18 days
timeFrame: Baseline and after 18 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian Sports University
Study officials:
References:
Clinical trial NCT03335995: Stroke Prognosis in Intensive CarE
Official title: Stroke Prognosis in Intensive CarE - The SPICE Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Stroke Patients Requiring Invasive Mechanical Ventilation
Keywords: mechanical invasive ventilation
course of the care
prognosis
stroke
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2017-11-08
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects included in this study are adult patients requiring invasive mechanical ventilation at the acute phase of stroke (within 7 days of stroke onset), irrespective of indication for intubation.

Prolonged mechanical ventilation of several days to weeks in ICU may be required for some patients, with various ICU discharge trajectories in survivors.

Brief summary: The S.P.I.C.E registry is an investigator-initiated prospective multicenter cohort study which will be conducted in 35 ICUS in the Paris area.The aim of the study is to determine the trajectory of acute stroke patients requiring invasive mechanical ventilation, focusing on functional outcomes at 3 months and 1 year following ICU admission. This project is funded by the French Agence Régionale de Santé (ARS).


Eligibility criteria: Inclusion criteria:

* Age\>18 years
* Acute stroke (acute ischaemic stroke, brain hemorrhage, subarachnoid hemorrhage). The stroke diagnosis date is defined by the date of the initial brain imaging (TDM or MRI).
* Admitted to ICU within 7 days before or after the diagnosis of stroke.
* Requiring invasive mechanical ventilation in ICU for more than 24 hours.

Exclusion criteria:

* Traumatic causes of stroke
* Refusal of the patient, or his reliable person, to participate in the study.
* Privation of liberty by administrative or judicial decision

Primary outcomes:
measure: Functional outcome
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat Hospital
Study officials:
affiliation: U 1137
name: Jean-François TIMSIT
role: STUDY_DIRECTOR
References:
citation: Sonneville R, Mazighi M, Bresson D, Crassard I, Crozier S, de Montmollin E, Degos V, Faugeras F, Gayat E, Josse L, Lamy C, Magalhaes E, Maldjian A, Ruckly S, Servan J, Vassel P, Vigue B, Timsit JF, Woimant F; SPICE investigators. Outcomes of Acute Stroke Patients Requiring Mechanical Ventilation: Study Protocol for the SPICE Multicenter Prospective Observational Study. Neurocrit Care. 2020 Apr;32(2):624-629. doi: 10.1007/s12028-019-00907-0.
Clinical trial NCT00771095: Pounds Off Digitally Study: A Podcasting Weight Loss Intervention
Official title: Pounds Off Digitally Study: A Podcasting Weight Loss Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Weight Loss
Keywords: weight loss
elaboration
self efficacy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: UNC Lineberger's Cancer Control Education Program
First posted: 2008-10-10
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants in both the existing and enhanced podcast groups will lose weight. The enhanced podcasting group will have a greater increase in weight loss, elaboration, self-efficacy, and perceived control than the existing podcast group.

Detailed description: We will conduct a weight loss intervention study among adults. Using the weight loss podcast that receives the highest rating from a previous content analysis, we will conduct an intervention comparing the best existing weight loss podcast to an enhanced podcast. The enhanced podcast will be based on theoretical constructs that have been shown to be effective in producing weight loss in other research studies. We will then evaluate the effectiveness of podcasting to promote weight loss in adults. Weight change from baseline to 12-weeks and changes in psychosocial measures will be used to assess differences between the existing podcast, enhanced podcast, and control conditions. In conclusion, this research study aims to find innovative and inexpensive ways to help people lose weight. Podcasting has the possibility of reaching a wide range of age and ethnic groups and will allow people to receive weight loss information when and where it is convenient for them.

Eligibility criteria: Inclusion Criteria:

be 18-50 years old be overweight or obese (BMI between 25-35) but not severely or morbidly obese live in the Chapel Hill area be able to attend an introduction meeting and weigh-in before the study and a weigh-in after the study have access to the Internet and a computer with a sound card have a working MP3 player that can connect to a computer have access to a scale be willing to be randomized to any group

Exclusion Criteria:

smoker current major health or psychiatric diseases, drug or alcohol dependency, uncontrolled thyroid conditions, eating disorder, or pregnancy participation in a weight loss program or taking weight loss medications

Primary outcomes:
measure: weight
timeFrame: 12 weeks
Secondary outcomes:
measure: elaboration
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill
state: North Carolina
Study officials:
References:
citation: Turner-McGrievy GM, Campbell MK, Tate DF, Truesdale KP, Bowling JM, Crosby L. Pounds Off Digitally study: a randomized podcasting weight-loss intervention. Am J Prev Med. 2009 Oct;37(4):263-9. doi: 10.1016/j.amepre.2009.06.010.
Clinical trial NCT00353795: Coronary Atherosclerosis Evaluation by Arterial Wall Magnetic Resonance Imaging (MRI)
Official title: Coronary Atherosclerosis Evaluation by Arterial Wall MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Arteriosclerosis
Arteriosclerosis, Coronary
Atherosclerosis, Coronary
Coronary Artery Disease
Coronary Atherosclerosis
Keywords: MESA
MRI
Cardiovascular
Cardiac
Coronary
Atherosclerosis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2006-07-19
Enrollment: 179
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The overall goal of this study is to use MRI to:

* Examine the relationship between known risk factors for cardiovascular disease and coronary artery wall thickness;
* Examine the relationship between coronary artery wall thickness and other markers of subclinical coronary atherosclerosis, such as carotid wall thickness and coronary calcium scores; and,
* Examine the feasibility of measuring the progression of coronary artery wall thickness over time in a subset of participants.

Detailed description: Each enrolled participant will undergo MR Imaging of the coronary arteries in conjunction with their routine MESA follow-up visit. The MRI will last approximately 45-60 minutes

Eligibility criteria: Inclusion Criteria:

* Prior enrollment in the MESA Study at the Hopkins MESA Field Center or the Northwestern University MESA Field Center
* Male or Female adult equal to or older than 45 years of age
* Willing/able to provide informed consent

Exclusion Criteria:

* Any known contraindications to MRI (i.e. severe claustrophobia, pacemaker, etc.)
* Metal in the eyes

Primary outcomes:
measure: Mean Coronary Wall Thickness
timeFrame: n/a (cross sectional analysis)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University MESA Field Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins MESA Field Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: David A Bluemke, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02936895: Vitamin D Supplementation and Respiratory Index of Severity in Children (RISC) in Pneumonia
Official title: The Effects of Vitamin D Supplementation in Respiratory Index of Severity in Children (RISC) of Hospitalized Patients With Community-acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumonia
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Childhood deaths from pneumonia is almost 2000 times higher in developing countries than in developed countries. In 1970, pneumonia was responsible for 9% of all deaths in children under 5 years. This rate was 2% in 2007.

Some studies have shown that supplementing with vitamin D reduces disease of the respiratory tract infection. Some other studies have shown anti-inflammatory effect of vitamin D in cell lines. Studies about the role of vitamin D supplementation in pneumonia in children are inadequate to conclude about its role.

The aim of this study is to determine the efficacy of vitamin D supplementation in Respiratory Index of Severity in Children (RISC) hospitalized clinical outcomes of hospitalized patients with community-acquired pneumonia.


Eligibility criteria: Inclusion criteria

* Aged between 2 months to 6 years
* Definite diagnosis of pneumonia

Exclusion criteria

* Immunocompromised patients
* Airway hypersensitivity or asthma
* allergies
* nasal polyps
* Using inhaled medications to one month prior to the study
* Receiving high doses of vitamin D
* Avoiding to complete informed consent form

Primary outcomes:
measure: Respiratory Index of Severity in Children (RISC)
timeFrame: through study completion, an average of 4 days
Secondary outcomes:
measure: Duration of hospitalization
timeFrame: through study completion, an average of 4 days
Other outcomes:
Locations:
city: Bandar Abbas
country: Iran, Islamic Republic of
facility: Shahid Mohammadi hospital
state: Hormozgan
Study officials:
References:
Clinical trial NCT01493895: Study Assessing Safety and Efficacy of B-cure Laser Treating Diabetic Chronic Wounds
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetic Foot Ulcer
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-12-16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: For centuries, light has been a well-known and effective healing method. In the beginning of the 20th century there was a first attempt to condense light energy and distribute it in higher levels, a use that was successfully applied on many soldiers wounded in the Second World War. The laser, which is based on the quantum phenomenon of stimulated emission, was first demonstrated in the beginning of the 1960s and immediately received many applications in all areas of medicine.Many different studies were carried out in the past decade trying to assess the effect of laser therapy on properties of healing wounds. This study aim to assess the efficacy and safety of Low-Level Laser Therapy (LLLT) in the treatment of non-healing diabetic foot ulcers.


Eligibility criteria: Inclusion Criteria:

1. Known Diabetes mellitus
2. With an active chronic wound in the foot, that has been treated conventionally for over 3 months.
3. No known osteomyelitis.
4. Size of wound: 1-8 cm2.
5. Ages: 21 - 75
6. Gender: male and female

Exclusion Criteria:

1. Signs of osteomyelitis.
2. The ability to probe to bone with the presence of local or systemic infection and suggestive radiological features provided a clinical diagnosis of osteomyelitis.
3. There is active osteomyelitis in the bone underlying the ulcer.
4. Pregnant women.
5. Children under 21.
6. Presence of or known cancerous comorbidity.

Primary outcomes:
measure: To assess the efficacy of b-cure laser in patients with diabetes mellitus induced lower leg skin ulcers
Secondary outcomes:
measure: safety
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
citation: Haze A, Gavish L, Elishoov O, Shorka D, Tsohar T, Gellman YN, Liebergall M. Treatment of diabetic foot ulcers in a frail population with severe co-morbidities using at-home photobiomodulation laser therapy: a double-blind, randomized, sham-controlled pilot clinical study. Lasers Med Sci. 2022 Mar;37(2):919-928. doi: 10.1007/s10103-021-03335-9. Epub 2021 May 29.
Clinical trial NCT05387395: COVID-19 on Disease Activity in Radiologically Isolated Syndrome Cohort
Official title: Impact of COVID 19 Vaccination or Infection on Disease Activity in Radiologically Isolated Syndrome Cohort: the VaxiRIS Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
COVID-19
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients fulfilling the Radiologic Isolated Syndrome criteria

Brief summary: The Radiologically Isolated Syndrome (RIS) is defined as incidental Magnetic Resonance Imaging (MRI) abnormalities fulfil the criteria for dissemination in space, suggestive of multiple sclerosis. Nowadays, mandatory vaccination in patients with multiple sclerosis (MS) is widely recommended. Regarding COVID19, the absence of specific warnings led to the proposal of vaccination in patients with inflammatory diseases of the central nervous system. We aimed to evaluate if COVID19 vaccination or infection increased the risk of clinical conversion to multiple sclerosis or evidence of disease activity (EDA) in a cohort of RIS subjects.


Eligibility criteria: Inclusion Criteria:

* patients belong to the RISC cohort;
* totally vaccinated ou partially vaccinated patient
* vaccination status known

Exclusion Criteria:

* presented a first clinical event before the COVID19 vaccination

Primary outcomes:
measure: COVID 19 vaccination and clinical conversion to multiple sclerosis risk
timeFrame: year 2
Secondary outcomes:
measure: COVID 19 vaccination and evidence disease activity risk
timeFrame: year 2
measure: multiple sclerosis evolution and history of COVID 19 infection
timeFrame: year 2
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References: