louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03934437: Leveraging mHealth and Peers to Engage African- Americans and Latinxs in HIV Care (LEAN)
Official title: Leveraging mHealth and Peers to Engage African-Americans and Latinxs in HIV Care (LEAN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2019-05-01
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pragmatic randomized controlled study comparing existing linkage to care and retention (LTCR) services to an mHealth-enhanced linkage to care and retention (mLTCR) protocol.

Detailed description: Baltimore's HIV prevalence rate (586/100,000) is among the top 5 in metropolitan areas in the US, and disparities are profound. African Americans have an HIV prevalence that is 5 times higher than among whites, and account for 78% of all HIV cases. Latinxs also have a higher prevalence of HIV than whites and are at the highest risk for late HIV diagnosis among all racial/ethnic groups. In addition, HIV viral load suppression, which is the best predictor of long-term survival among HIV-infected patients, is substantially lower among minority populations in Baltimore.

The overall goal of this proposal is to evaluate whether mHealth-enhanced Linkage to Care and Retention (mLTCR) can improve HIV outcomes among HIV-infected African Americans and Latinos compared to standard Linkage to Care and Retention (LTCR) programs. The mHealth-enhancement consists of two smartphone applications (app), one for patients and one for patient supporters (e.g. linkage officers, patient navigators, nurses, etc.), to help facilitate communication. Communication will focus on issues related to HIV care (e.g. appointment scheduling, transportation), as well as patient-directed requests. Using HIV surveillance data (e.g. unsuppressed HIV viral load), patient supporters will be automatically alerted if a patient has a high viral load and prompted to contact the patient. In addition to appointment reminders, patients will receive positive reinforcement behavioral text messages.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Ability to provide consent
* Identified by BCHD Linkage protocol to be a new HIV diagnosis or HIV-infected and "out of care"
* Identified by participating clinics as needing patient support services

Exclusion Criteria:

* Not able to provide consent.

Primary outcomes:
measure: Participants With HIV Viral Load Suppression (Copies/cc)
timeFrame: 12 months
Secondary outcomes:
measure: Participants Retained in Care
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore City Health Department
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Kathleen W Page
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03103737: Promotion of Emotional Well-being in Hospitalized Cancer Patients by Information and Communication Technologies (ICTs)
Official title: Evaluation of a Brief Psychological Intervention That Uses ICTs to Improve Well-being in Hospitalized Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Well-being
Information and communication technologies
Hospital
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Hospital Clínica Benidorm
name: Universitat Jaume I
name: Universitat Politècnica de València
First posted: 2017-04-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to test the efficacy of a brief psychological intervention composed by two therapeutic modules (virtual environments and reminiscence techniques) for the promotion of wellbeing of hospitalized adult cancer patients. Participants are randomly assigned to 2 conditions: intervention condition and control condition.


Eligibility criteria: Inclusion Criteria:

* adults with any cancer diagnosis
* hospitalized for at least 1 week
* Karnofsky functional state ≥50
* life expectancy ≥2 months

Exclusion Criteria:

* serious psychopathology
* cognitive impairment

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983; adapted version of Tejero, Guimerá, Farré & Peri, 1986)
timeFrame: Change from baseline to 1 week
measure: Fordyce Happiness Scale (Fordyce, 1988).
timeFrame: Change from baseline to 1 week
Secondary outcomes:
measure: Visual Analog Scale: Mood.
timeFrame: 4 days along 1 week
measure: Visual Analog Scale: Emotional State. Change pre-post sessions.
timeFrame: 4 days along 1 week
measure: Visual Analog Scale: Physical Discomfort. Change pre-post sessions.
timeFrame: 4 days along 1 week
measure: Visual Analog Scale: Satisfaction with the Session
timeFrame: 4 days along 1 week
measure: Satisfaction with Intervention Scale (adapted version of Borkovec and Nau's, 1972).
timeFrame: 1 week
measure: Distress Thermometer (Roth et al., 1998).
timeFrame: Change from baseline to 1 week
measure: Time perception (based on Bayés et al., 1997).
timeFrame: 4 days along 1 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05090137: Quantifying Congestion by Ultrasound
Official title: Quantifying Interstitial and Intravascular Fluid Accumulation by Ultrasound Following Temporary Suspension of Loop Diuretics in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The investigators will determine the feasibility of identifying and quantifying changes in interstitial and intravascular congestion by imaging in participants with heart failure. The investigators will either continue or temporarily suspend both loop diuretics and mineralo-corticoid antagonists (MRA) for 48 hours in participants with heart failure that is both stable and mild and compare measurements of interstitial (B-lines) and intra-vascular fluids (IVC and JV diameter and renal venous flow) by ultrasound and, in a subset of participants without contra-indications, by cardiac MRI.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of heart failure
* Plasma NT-proBNP \>125ng/L or BNP \>35 ng/l
* Left ventricular ejection fraction (LVEF) \<50% on prior imaging test
* Treated routinely with a daily dose of loop diuretic
* Receiving other guideline-indicated therapy for heart failure
* Willing to sign the informed consent form
* Greater than 18 years of age

Exclusion Criteria:

* Chronic Kidney Disease Stage 4 or worse (eGFR \<30 mL/min/1.73 m²)
* Atrial fibrillation
* Significant valve disease (investigators opinion)
* Breathlessness or chest pain at rest or minor exertion
* Patients unable to lie flat
* Patients deemed too unstable to miss treatment with diuretics for 48 hours
* Patients taking part in another interventional trial
* Any other concomitant condition that in the opinion of the investigator would not allow a safe participation in the study (ie:-pregnancy, significant frailty)
* Patients unwilling or unable to consent
* For patients willing to undergo MRI; contraindication to MRI including claustrophobia, metalworkers, and intra-orbital or intracranial metal (eg:- stents), and non-MRI compliant device.

Primary outcomes:
measure: Differences in ultrasound markers or congestion following continuation or suspension of diuretics for 48 hours.
timeFrame: at baseline
Secondary outcomes:
measure: The acute variation in interstitial and intravascular congestion on imaging tests following administration of diuretics.
timeFrame: up to 3 hours
measure: The acute variation in biomarkers of congestion, inflammation and myocardial injury following administration of diuretics.
timeFrame: at 3 hours
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
Study officials:
References:
Clinical trial NCT00906737: Effects of Targeted Lower Extremity Joint Training on Multiple Sclerosis (MS) Gait Abnormalities
Official title: Targeted Lower Extremity Joint Training Effects on MS Gait Abnormalities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Gait
foot-drop
Ankle-Bot
Physical Therapy
Gait Abnormalities
Lead sponsor: Mount Sinai Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 18
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to test the possible benefits of task-specific focused ankle training using the Ankle-Bot on subjects with Multiple Sclerosis who have "foot-drop." The study also compares the effectiveness of task-specific focused ankle training using the Ankle-Bot with conventional focused ankle therapy in improving the gait of subjects with MS.


Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of MS
* EDSS level between 3.5 - 6.0
* Unilateral foot-drop
* Able to ambulate 25 ft. with no more than a unilateral assistive device

Exclusion Criteria:

* Lower extremity injuries that limit range of motion or function
* Unable to demonstrate an understanding of the process of the study and/or fully understand instructions in order to safely participate in the study and use study equipment
* Unable to fit safely and properly into the Ankle-Bot device

Primary outcomes:
measure: Gait Parameters
timeFrame: Baseline, throughout study enrollment, and at 1 month and 3 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
state: Connecticut
Study officials:
affiliation: Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
name: Albert Lo, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03883737: Percutaneous Neuromodulation on the Anterior Pain Knee
Official title: Effect of the Ultrasound-guided Percutaneous Neuromodulation on the Anterior Pain Knee: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromodulation
Anterior Pain Knee
Femoral Nerve
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anterior knee pain (AKP) is one of the most frequent pathologies of the lower limb, in young and adult subjects. In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. The objective of this study is to analyze that the effect of PNM on the femoral nerve produces statistically significant changes in pain, joint range and knee functionality in patients with chronic AKP. Thirty subjects will be recruited, which will be divided into 2 groups: group 1 to which PNM will be applied to the femoral nerve of the pain knee; and group 2 to which PNM will be applied to the femoral nerve of the non-pain knee. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current (250 microseconds, 10 Hz)


Eligibility criteria: Inclusion Criteria:

* chronic anterior knee pain \>3 months
* older than 18 years-old

Exclusion Criteria:

* Surgical intervention in the intervention area
* Prosthesis or osteosynthesis in the intervention area
* Cardiac or tumoral diseases
* Coagulopathies
* Be under the effects of certain medications
* contraindication characteristic of the puncture

Primary outcomes:
measure: visual analog scale (VAS) (0, no pain; 100, maximum pain).
timeFrame: up to 1 week
measure: range joint
timeFrame: up to 1 week
measure: VISA-p questionnaire (0, maximum pain; 100, no pain).
timeFrame: up to 1 week
measure: Kujala questionnaire (0, maximum pain; 100, no pain).
timeFrame: up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: University of Seville
Study officials:
References:
Clinical trial NCT06668337: Ephedrine Doses to Prevent Maternal Hypotension After Spinal Anesthesia in Cesarean Section
Official title: A Randomized Controlled Trial Comparing the Effectiveness of Different Doses of Ephedrine Infusion in Preventing Maternal Hypotension Following Spinal Anesthesia for Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypotension After Spinal Anesthesia
Hypotension During Cesarean Delivery
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to compare the effectiveness of different doses of ephedrine infusion in preventing maternal hypotension following spinal anesthesia in parturients undergoing cesarean sections. The study includes 120 participants, aged 18-40 years, with American Society of Anesthesiologists (ASA) physical status II, who are scheduled for elective cesarean delivery. The primary objective is to determine whether low-dose ephedrine infusions at 1.25 mg/min or 1.5 mg/min effectively reduce the incidence of maternal hypotension, with secondary outcomes assessing the need for rescue ephedrine, incidence of side effects (nausea, vomiting, tachycardia), and neonatal Apgar scores. Researchers will compare three groups-saline, 1.25 mg/min ephedrine, and 1.5 mg/min ephedrine-to evaluate their impact on maternal hemodynamic stability.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing cesarean section
* Self-identified as female
* American Society of Anesthesiologists (ASA) physical status II
* Aged between 18 to 40 years
* Full-term singleton pregnancies planned for cesarean delivery under spinal anesthesia

Exclusion Criteria:

* Body mass index (BMI) ≥ 40 kg/m²
* Height less than 145 cm
* Presence of severe neurological or psychiatric conditions
* History of pre-eclampsia
* Severe renal or metabolic disorders
* Contraindications to spinal anesthesia
* Antenatal evidence of fetal anomalies
* Cases with severely compromised fetuses requiring immediate general anesthesia
* Baseline systolic blood pressure (SBP) less than 90 mm Hg
* Pregnancy-induced hypertension
* Refusal to provide written consent

Primary outcomes:
measure: Incidence of Hypotension in Patients Undergoing Cesarean Section Following Spinal Anesthesia.
timeFrame: Hypotension episodes were monitored and recorded intraoperatively, immediately following the administration of spinal anesthesia until the end of the cesarean section procedure. The time frame for evaluating this outcome was during the surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Dharan
country: Nepal
facility: B.P. koirala Institute of Health Sciences
Study officials:
References:
Clinical trial NCT00593437: T-score Comparability Between GE Lunar Prodigy and Norland Excel Densitometers
Official title: T-score Comparability Between GE Lunar Prodigy and Norland Excel Densitometers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Densitometry
Keywords: bone density diagnostic equipment discrepancies
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 35
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ambulatory women age ≥ 40 who have recently had a spine and hip DXA at the Wildwood Clinic on a Norland Excel densitometer

Brief summary: Differences in determining bone density scores have been found when comparing different bone density machines. Reducing differences between machines will improve diagnostic agreement for patients measured at different clinics. This study will test if this difference exists between the Norland Excel, such as the one at Wildwood Clinic, and the GE Healthcare Lunar Prodigy at the UW Osteoporosis Clinical Research Center.


Eligibility criteria: Inclusion Criteria:

* Ambulatory women age 40 years and older
* Recent spine and hip DXA at Wildwood clinic in Madison, WI

Primary outcomes:
measure: Spine and hip BMD and T-score measurements will be compared between densitometry machines.
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Osteoporosis Clinical and Research Program
state: Wisconsin
Study officials:
affiliation: University of Wisconsin - Institute on Aging
name: Neil Binkley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04115137: Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer: REPiVAC
Official title: Multicentric Spanish Record of Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer - Pelvic Congestion Syndrome: Study of Efficacy and Safety
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Congestion Syndrome
Pelvic Varicose Veins
Follow-up Study
Embolization, Therapeutic
Observational Study
Keywords: Pelvic Congestion Syndrome
amplatzer vascular plug
Vascular plug
metallic embolization device
Chronic pelvic pain
embolization procedure
Lead sponsor: Group of Research in Minimally Invasive Techniques
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women older than 18 years , minimun 1 bith and with symptoms of pelvic congestion syndrome

Brief summary: Spanish multicentric record to study the efficacy and safety of the treatment with plugs in Pelvic Congestion Syndrome.

Detailed description: This is an prospective observational study of patients that have been treated with plugs (type Amplazer) at least one of the pelvic varicose veins.

Patients are recruited when the plug is implanted, and the investigators perfom a patients follow-up during 1, 3, 6, 12, 24 months

Eligibility criteria: Inclusion Criteria:

* Female \< 18 years
* Present symptomatology
* At least one image diagnosis

Exclusion Criteria:

* Female \> 18
* Non present symptomatology
* Non diagnosis

Primary outcomes:
measure: Embolization of pelvic varicose veins using AVP
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Lozano Blesa Universitary Hospital
state: Aragon
city: Madrid
country: Spain
facility: Hospital Vithas Nisa Pardo de Aravaca
Study officials:
affiliation: Minimal Invasive Techniques Research Group
name: Miguel A De Gregorio, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01473537: Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium
Official title: A Double Blind, Randomized, Cross Over Designed Trial of Fluoride Prevention by Double Rinse With Calcium and Fluoride
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dental Caries
Keywords: dental caries/prevention and control
oral health
cariostatic agents
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Aim: to determine the optimal Ca2+ concentration with 905 ppm F as NaF. Study design: Experimental study in 10 volunteers. Single blind mouth rinse with calcium lactate solution (150; 75; 0 mM Ca-lactate) is immediately followed by a standard fluoride rinse.

Procedure: Rinses are performed in the evening. The rinse combinations are given in a random order, and the subjects are unaware of the sequence. At least 3 days separates the use of each rinse. Dosage: 20 mL and 1 minute rinse with each solution.

Saliva samples: Twelve hours after rinsing, unstimulated saliva samples are collected by expectoration.

Analysis: The fluoride concentration in saliva samples are analysed Statistics and data handling: Fluoride in saliva 12 hours after rinsing are examined by one-way ANOVA, repeated measures design.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* 10 natural teeth or more
* willing to refrain from use of fluoride containing products
* signed informed consent

Exclusion Criteria:

* less than 10 natural teeth
* reduced cognitive skills
* does not speak and/or understand Swedish
* ongoing oral or systemic infections
* pregnancy
* breast feeding

Primary outcomes:
measure: Fluoride concentration in resting saliva
timeFrame: 12 hours after rinse
Secondary outcomes:
measure: Discomfort by calcium lactate rinse
timeFrame: 12 hours after rinse
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska Institutet, Dept Dental Medicine
Study officials:
affiliation: Karolinska Institutet
name: Gunilla Sandborgh-Englund, Prof, DDS
role: PRINCIPAL_INVESTIGATOR
References: