louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05104138: Eplerenone Versus PDT: Comparative Study by OCTA
Official title: OCTA in Central Serous Chorioratinopathy Treated With Oral Eplerenone or Hal-fluence Photodynamic Therapy: a Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Serous Chorioretinopathy
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participans were older than 40 years with central serous chorioretinopathy. They did not present other ophthalmological diseases

Brief summary: The study aims to analyze the changes in OCTA parameters and in choroidal thickness in patients affected by central serous chorioretinopathy treated by oral eplerenone and half-fluence photodynamic therapy.

Detailed description: Central serous chorioretinopathy (CSC) is a chorioretinal disease characterized by serous detachment due to the dilatation and hyperpermeability of choroidal vessels resulting in the accumulation of serous fluid between the neurosensory retina and the retinal pigment epithelium.

Several studies reported the efficacy of half-fluence photodynamic therapy (PDT) and oral eplerenone in the CSC treatment inducing a reduction of the choroidal hyperpermeability and remodeling the choroidal vascularization.

This retrospective study aims to perform a quantitative analysis of retinal and CC vessel density by OCTA at baseline, 3 and 6 months in patients underwent PDT and patients underwent eplerenone.

Eligibility criteria: Inclusion Criteria:

* age older than 30 years
* diagnosis of central serous chorioretinopathy
* treatment-naïve with half-fluence photodynamic therapy or oral eplerenone
* absence of vitreoretinal and vascular retinal diseases

Exclusion Criteria:

* age younger than 30 years
* absence of diagnosis of central serous chorioretinopathy
* previous treatment with half-fluence photodynamic therapy or oral eplerenone
* presence of concomitant vitreoretinal and vascular retinal diseases

Primary outcomes:
measure: Study of vessel density in retinal choriocapillaris networks, using OCTA, in patients underwent half fluence photodynamic therapy and oral eplerenone
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Università Federico II
name: Gilda Cennamo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01760538: Study on Heart Rate Variability in Cardiac Transplant Recipients With Exercise and After Exercise Training
Official title: Study on Heart Rate Variability in Cardiac Transplant Recipients With Exercise and After Exercise Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Transplant Disorder
Keywords: Cardiac transplant recipients
Heart rate variability
Exercise training
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to investigate the changes on heart rate variability, exercise capacity, activities of daily living, and quality of life after aerobic exercise training in cardiac transplant recipients.


Eligibility criteria: Inclusion Criteria:

* Heart transplant recipients with stable post operation condition
* Age between 20-70 years
* No acute or severe chronic rejection

Exclusion Criteria:

* Any condition that might affect exercise performance

Primary outcomes:
measure: Heart rate variability
timeFrame: 8 weeks
Secondary outcomes:
measure: Exercise capacity
timeFrame: 8 weeks
measure: Quality of life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ying-Tai Wu, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04264338: Thyromental Height Test as a Predictor of Difficult Airway:
Official title: The Validity of the Thyromental Height Test as a Predictor of the Difficult Airway: A Prospective Comparative Study With Interincisor Distance, Thyromental Distance, Sternomental Distance & Modified Mallampati Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Difficult Intubation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 612
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients, aged from 18-60 years old, with ASA physical status I \& II who will undergo elective surgical procedures under general anesthesia using endotracheal intubation using conventional laryngoscopy.

Brief summary: Anesthesia is increasingly safe. Major complications of airway management are no more common but still the most life-threatening condition amongst anesthesia practice and even medicine. Thyromental height test (TMHT) is an objective measure of the height between the anterior borders of the mentum and thyroid cartilage, measured while the patient is lying supine with the mouth closed. This study was designed to assess the validity of the TMHT as a single objective predictor for difficult laryngoscopy and to be compared to other objective measures.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I \& II
* Scheduled for elective surgical procedures under general anesthesia using endotracheal with conventional laryngoscopy

Exclusion Criteria:

* Patients with a body mass index \>35 kg/m2.
* Patients with neuromuscular disorders, craniofacial abnormalities, and abnormal dentition.
* Patients with airway diseases e.g cancer larynx or tongue, uncooperative patients, those who will need awake intubation and patients who will undergo emergency operations.

Primary outcomes:
measure: validity of the TMHT in prediction of difficult airway in patients undergoing general anesthesia for elective surgeries using area under ROC curve for the TMHT.
timeFrame: baseline (before induction of general anesthesia)
measure: Validity of TMHT in comparison with that of Modified Mallampati test (MMT) in prediction of difficult airway by comparing area under ROC curve for both tests.
timeFrame: baseline (before induction of general anesthesia)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01487538: Weight Maintenance Through Physical Activity and Social Support in Rural Middle-Aged Women
Official title: Weight Maintenance Through Physical Activity and Social Support in Rural Middle-Aged Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight Changes
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2011-12-07
Enrollment: 52
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare an technology-based weight maintenance intervention using action plans, videos discussion boards and health behavior tracking (weight, calories in and out, pedometer steps) with a technology-based standard advice group to facilitate health management, resourcefulness and health status for rural middle-aged women.

Detailed description: The purpose of this research project is to evaluate the influence of a theory-based intervention using the Health Effects of Life Transitions for Women Model to promote maintenance of initial weight loss. The intervention will be designed to promote physical activity to prevent weight regain among an underserved and vulnerable population of rural, mid-life women. The intervention delivered through action plans, videos, discussion boards and health behavior tracking (weight, calories in and out, pedometer steps) to facilitate health management, resourcefulness and health status will be compared with the standard advice group who receives newsletters and health behavior tracking (weight) to initiate, increase, or sustain physical activity for weight maintenance.

Eligibility criteria: Inclusion Criteria:

Women:

* aged 40-64 years;
* reported intentional weight loss of 5-10% of initial body weight within previous 6 months;
* residing in a rural county (population \< 50,000 residents) or rural community (population less than 2,500) within driving distance of a UNMC College of Nursing campus;
* ability to communicate in English (verbal and written);
* ambulatory and can walk at least one block without the use of an assistive device, such as a cane, walker, or wheelchair;
* have access to the internet and current email account; and
* answer 'no' to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) or obtain clearance from their physician to become more active.

Exclusion Criteria:

* instructed by a physician not to exercise;
* presence of chest pain, shortness of breath, or feelings of light-headedness upon exertion.

Primary outcomes:
measure: weight maintenance
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Southeast District Health Department
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Teresa Hultquist, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03187938: Alkaline Phosphatase Level in Pregnancy and Its Association With Birth Weight
Official title: Alkaline Phosphatase Level in Pregnancy and Its Association With Birth Weight
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Birth Weight Infants
Keywords: Alkaline Phosphatase
Pregnancy
Suboptimal fetal growth
Placental insufficiency
Low birth weight
IUGR
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 292
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women, aged 18 and older, who are seen for their prenatal care and who are between 24w0d and 28w6d weeks gestation.

Brief summary: Alkaline phosphatase is known to be produced by syncytiotrophoblasts in the placenta and its levels are normally increased in pregnancy. Therefore, it would be reasonable to hypothesize that alkaline phosphatase would be low to low normal in cases of low birth weight / intrauterine growth restriction (IUGR)/ placental insufficiency.

Detailed description: The purpose of this study will be to determine if alkaline phosphatase can be used as a predictor for suboptimal fetal growth, placental insufficiency and low birth weight (birth weight less than 2500 grams). It will also help determine if alkaline phosphatase can be used as a screening tool for low birth weight/IUGR at the time of the 24 to 28 week labs.

Eligibility criteria: Inclusion Criteria:

• Patients enrolled between 24w0d and 28w6d weeks gestational age will be included. The blood specimen of the patients enrolled will be held until delivery.

Exclusion Criteria:

* Multiple gestations
* Known congenital malformations (any, except Pyelectasis)
* Chronic hypertension
* Inflammatory bowel disease (IBD)
* Gall bladder disease
* Active bone disease (ie, skeletal dysplasia, healing fracture)
* Active liver disease (ie, hepatitis, cholestasis, cholelithiasis (gallstones))
* Pre-existing type 1 and 2 Diabetes
* Early-onset IUGR

Primary outcomes:
measure: Birth Weight at Delivery
timeFrame: At Delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan TriHealth Hospital
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Donna Lambers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00051038: Study of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients
Official title: A Phase II Study of the Safety and Efficacy of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients Who Have Hepatitis B Viremia While Being Treated With Lamivudine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hepatitis B
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2003-01-03
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study is to assess the safety and effectiveness of entecavir, when being added to lamivudine, in the treatment of adults with chronic hepatitis B infection who are co-infected with HIV.


Eligibility criteria: * Documented history of co-infection with HIV and HBV
* Stable Anti Retroviral Therapy regimen containing lamivudine 150 mg BID for at least 24 weeks prior to enrollment;
* Documented HBV viremia on screening and at least at 4 weeks prior to screening
* HBe Ag-positive or HBe Ag-negative / anti-HBe-positive
* HIV viral load below 400 copies/mL by the Roche Amplicor(TM) 1.5 HIV PCR assay at screening and equally low at least 12 weeks prior to screening
* Absence of Co-Infection with hepatitis C virus (HCV) or hepatitis D virus (HDV)
* Absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease
* Less that 1/2 weeks of prior therapy with nucleoside/nucleotide analogue (excluding lamivudine) with activity against HBV (including e.g. famciclovir, tenofovir, ganciclovir, adefovir). No receipt of any of these therapies within 24 weeks prior to randomization into this study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Local Institution
state: Connecticut
city: Altamonte Springs
country: United States
facility: Local Institution
state: Florida
city: Lousiville
country: United States
facility: Local Institution
state: Kentucky
city: Charlotte
country: United States
facility: Local Institution
state: North Carolina
city: Pittsburgh
country: United States
facility: Local Institution
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03849638: Gait Analysis and Gait Training in Patient With Total Hip or Total Knee Replacement
Official title: Gait Analysis and Gait Training in Subjects 1 Year After Total Hip or Total Knee Replacement by Means
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Arthroplasty, Replacement, Hip
Keywords: gait analysis
gait training
biofeedback
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of the present study is the evaluation of the kinematic parameters of gait and distribution of the load, recorded thruogh a sensorized treadmill, on lower limbs in patients at 1 year from Total Hip Replacement or Total Knee Replacement.

The secondary objective is to evaluate the effects of gait training with biofeedback by means of a sensorized treadmill in patients with asymmetry of the kinematic parameters of the step and of distribution of the load on the lower limbs.


Eligibility criteria: Inclusion Criteria:

* Mini Mental State Examination ≥ 24
* 12 months after total hip or total knee replacement

Exclusion Criteria:

* impossibility to perform a walking test
* disabling cardiovascular and osteo-arthro-muscular problems that can impair walking tests
* central or peripheral neurological disorders that compromise the sensory-motor skills of the patient under examination and / or the degree of collaboration
* patients who have not signed informed consent

Primary outcomes:
measure: Gait Speed
timeFrame: immediately after treatment
measure: Step Length
timeFrame: immediately after treatment
measure: Ground Contact Time
timeFrame: immediately after treatment
measure: Hip Kinematics
timeFrame: immediately after treatment
measure: Knee Kinematics
timeFrame: immediately after treatment
measure: Ankle Kinematics
timeFrame: immediately after treatment
measure: Lower limb loading
timeFrame: immediately after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Rehabilitation Department - Campus Bio-Medico University
state: RM
Study officials:
References:
Clinical trial NCT04993638: Post Market Clinical Follow-up of Dual-mobility Acetabular Cup EUROSCUP MOBILE
Official title: Post Market Clinical Follow-up of Dual-mobility Acetabular Cup EUROSCUP MOBILE
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hip Arthropathy
Hip Osteoarthritis
Hip Arthritis
Hip Fractures
Hip Necrosis
Hip Dysplasia
Lead sponsor: EUROS
Sponsor class: INDUSTRY
First posted: 2021-08-06
Enrollment: 147
Sex: ALL
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: NON_PROBABILITY_SAMPLE
Study population: Patient who fulfill the criteria of eligilibilty according to the instructions for use of EUROSCUP MOBILE

Brief summary: EUROSCUP MOBILE is intended for use in primary and revision total hip replacement surgery.

Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

As part of post market vigilance, EUROS will collect data on EUROSCUP MOBILE performances and safety

Detailed description: Post market observational study. This study is retropective and prospective, non comparative.

Eligibility criteria: Inclusion Criteria:

* Patient who received EUROSCUP MOBILE.
* Patient informed of its participation to the study
* Patient aged between 18 and 80 years old (\<80).

Exclusion Criteria:

* Patient presenting a contraindication to EUROSCUP MOBILE implantation.
* Patient who refused to participate to the study
* Vulnerable subjects

Primary outcomes:
measure: Safety of EUROSCUP MOBILE
timeFrame: 1 year
Secondary outcomes:
measure: Radiological performances of EUROSCUP MOBILE
timeFrame: 1 year
measure: Clinical performances of EUROSCUP MOBILE
timeFrame: 1 year
measure: Survival of EUROSCUP MOBILE
timeFrame: 10 year
Other outcomes:
Locations:
city: Avignon
country: France
facility: Clinique Montagard
city: Clermont-Ferrand
country: France
facility: CHU Gabriel Montpied
city: Lyon
country: France
facility: Hôpital Saint Joseph-Saint Luc
Study officials:
References:
Clinical trial NCT06064838: Effects of Cacao Flavonoids in Long COVID-19 Patients (FLALOC)
Official title: Effects of Cacao Flavonoids in Long COVID-19 Patients with Chronic Fatigue (FLALOC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long Covid19
Fatigue Syndrome, Chronic
Keywords: flavonoids
post-covid
Lead sponsor: National Polytechnic Institute, Mexico
Sponsor class: OTHER
Collaborators: name: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
First posted: 2023-10-03
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blind, placebo-controlled clinical trial will be conducted at the specialty clinic Indianilla in Mexico City, during the period from August 2023 to September 2024 with post-covid patients with chronic fatigue.
Primary purpose: TREATMENT

Brief summary: The study use a triple blind, placebo-controlled design enrolling male and female subjects between 30-70 yo to evaluate the effect of daily consumption of a cacao supplement on inflammation, endothelial damage, handgrip strength, fatigue scale and quality of life.

Detailed description: The study use a triple blind, placebo-controlled design enrolling male and female subjects between 30-70 yo distributed homogeneously at random in two groups: the control group (Placebo) and the intervention group (Cacao Flavonoids) both groups affected for 90 days.

The variables to consider will be: Interleukins (IL-1b, IL-6), Tumoral Necrosis Factor alpha (TNF-α) and syndecan-1.

For physical performance is evaluated the handgrip strength. The investigators also assessed quality of life using the Health Related QoL (EQ-5D) questionnaire, and the numerical fatigue rating scale.

Eligibility criteria: Inclusion Criteria:

* Post-COVID-19 patients, at least 6 months after symptom onset
* Chronic fatigue

Exclusion Criteria:

* Allergy or intolerance caused by active ingredients
* Pregnancy or lactation
* BMI \>35
* chronic liver disease
* chronic kidney disease

Primary outcomes:
measure: Interleukin-1b
timeFrame: At 0 and 90 day
measure: Interleukin-6
timeFrame: At 0 and 90 day
measure: TNF-alpha
timeFrame: At 0 and 90 day
measure: Syndecan-1
timeFrame: At 0 and 90 day
Secondary outcomes:
measure: EQ-5D questionnaire
timeFrame: At 0 and 90 day
measure: Analog Visual Scale
timeFrame: At 0 and 90 day
measure: Numerical fatigue rating scale
timeFrame: At 0 and 90 day
measure: Handgrip strength
timeFrame: At 0 and 90 day
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: C.E. Indianilla
Study officials:
References: