louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01533896: Can a Brief Primary Care Intervention Affect Healthy Weight Habits
Official title: Can a Brief Primary Care Intervention Affect Healthy Weight Habits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity prevention
Primary care
Education
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 221
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Parents should receive anticipatory guidance about obesity prevention as part of the routine well child visit. Educational resources are needed to help physicians routinely provide these important anticipatory guidance messages. In this study, consecutive parents will be exposed to routine anticipatory guidance messages before the well child visit with the physician. After the clinic visit, parents will be invited to participate in a research study to determine if they plan any changes at home. The key research question of this study is: Can a brief multimedia intervention help parents develop plans to help their children have a healthy weight?


Eligibility criteria: Inclusion Criteria:

* English and Spanish speaking parents of 2-12 year old children presenting to the pediatric primary care clinic.

Exclusion Criteria:

* Parent does not speak English or Spanish.
* Child presenting for an acute care visit.

Primary outcomes:
measure: Changes in healthy weight habits
timeFrame: 2 -4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Pediatric Primary Care Clinic
state: Tennessee
Study officials:
References:
Clinical trial NCT01358396: Glycemic Control and Diabetic Macular Edema
Official title: The Effect of Glycemic Control on Visual and Anatomical Outcomes in Response to Therapy for Diabetic Macular Edema.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema, Glycemic Control
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2011-05-23
Enrollment: 52
Sex: ALL
Minimum age (years): 20
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: Diabetic patients with macular edema with central foveal thickness more than 250 microns and no proliferative changes.

Brief summary: Does diabetic patients' glycemic control affect their response to laser and/or intravitreal injection therapy in terms of visual and anatomical outcomes.

Detailed description: To evaluate the visual and anatomical response to therapy in patients with diabetic macular edema (DME) in relation to their glycemic control.

Patients with DME with central foveal thickness (CFT) \> 250µm with no proliferative disease had their glycosolated hemoglobin (HbA1c) measured at baseline and 3 months. CFT by optical coherence tomography, and best corrected visual acuity (BCVA) in logMARs were measured at baseline, 1, and 3 months. Exclusion criteria: laser or intravitreal injections within 6 months, hard exudates within 500um of the foveal center, or macular traction. Therapy included laser and intravitreal anti VEGFs. HbA1c graded as: G1=\<7%, G2= 7-7.9%, G3= 8-8.9%, G4 = \>9%; and as: low \<8%, high ≥ 8%.

Eligibility criteria: Inclusion Criteria:

* Central foveal thickness more than 250 microns

Exclusion Criteria:

* Proliferative Diabetic Retinopathy.
* Traction Macular Membranes
* Previous Laser or intravitreal injections within 6 months.

Primary outcomes:
measure: Visual Acuity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT06057896: Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Official title: Combined Natural Molecules Improve Markers of Metabolic Syndrome and Climacteric in Menopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Climacteric Syndrome
Metabolic Syndrome
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 200
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in menopause exhibiting at least three of the diagnostic criteria for metabolic syndrome

Brief summary: The study collected retrospective data from the assumption of combined natural molecules in menopausal women with metabolic syndrome


Eligibility criteria: Inclusion Criteria:

* menopause
* diagnosis of metabolic syndrome

Exclusion Criteria:

* pharmacologically-induced menopause
* hormonal therapies
* sensitizing insulin therapies
* cancer patient or ex-cancer patient

Primary outcomes:
measure: Body mass index
timeFrame: [0, 6 months]
Secondary outcomes:
measure: Climacteric
timeFrame: [0, 6 months]
measure: Climateric
timeFrame: [0, 6 months]
Other outcomes:
Locations:
city: Naples
country: Italy
facility: SCCAL
Study officials:
affiliation: ASL NA3 Sud, Naples, Italy.
name: Mario Passaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00911196: Analysis of Expression of Specific Markers and Their Prognostic Significance in Hepatocellular Carcinoma
Official title: Analysis of the Incidence of Expression of Tumor Antigens and Tumor Marker in Cancer Tissue From Asian Patients With Hepatocellular Carcinoma and Evaluation of Prognostic Significance of These Tumor Antigens.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Prognosis
Markers
Expression analysis
Hepatocellular carcinoma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-06-01
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: Hepatocellular carcinoma is an aggressive disease with limited therapeutic options. Therefore, new approaches to treat this type of cancer are needed with immunotherapy potentially being one of these. As a first step in the development of novel therapies, expression analysis of specific markers, including tumor antigens will be carried out, and the correlation of expression with disease variables and clinical outcome will be assessed. This will be done retrospectively using archived hepatocellular carcinoma tissue samples.


Eligibility criteria: Inclusion Criteria:

* The patient has pathologically proven hepatocellular carcinoma (any stage)
* All the data required are available from patient's records

Exclusion Criteria:

N/A

Primary outcomes:
measure: The proportion of hepatocellular carcinoma patients whose tumor tissue expresses specific tumor antigens.
timeFrame: At the time of analysis
measure: The prognostic character of the expression of the tumor antigens
timeFrame: At the time of analysis
measure: Expression of c-MET in the same hepatocellular carcinoma tumor samples
timeFrame: At the time of analysis
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Chiangmai
country: Thailand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04513496: Telemedicine in HIV Care in Buenos Aires
Official title: Delivery of HIV Care Through Telemedicine in Public Hospitals in Buenos Aires, Argentina During COVID-19 Pandemic: Implementation Research
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Telemedicine
HIV-1-infection
Lead sponsor: Fundacion Ibis
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 4000
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: PLWH(people living with HIV) that receive care in Buenos Aires public hospitals

Brief summary: The aim of this investigation is to conduct an implementation research to facilitate and evaluate the implementation of VCT((Videoconsult through telemedicine) among HIV HCP(healthcare providers) and PLWH(people living with HIV)

Detailed description: Through prospective observational methodology the investigators are planning to evaluate VCT(Videoconsult through telemedicine) implementation. Both quantitative and qualitative analysis (mixed methods) will take part in the assessment. Quantitative data will be useful to obtain objective data in terms of proportion of subjects using the intervention, adoption by health care workers and measuring effectiveness. Additionally, qualitative methods will help to understand the outcomes focusing on the barriers and facilitators from both the HCW and patients, and their feedback on continuous implementation.

Hence, perceptions of a vast group of patients and HCW will take a critical point in the qualitative analysis. Finally, by evidencing effectiveness, the investigators will be able to generalize and maintain this intervention as a good clinical practice. Due to the scope of the outcomes, the investigators will use RE-AIM framework.

Eligibility criteria: Inclusion Criteria:

* 18 years-old or older
* Access to internet
* Willing to participate

Exclusion Criteria:

* do not understand the purpose and study procedures

Primary outcomes:
measure: Telemedicine Reach. RE-AIM framework
timeFrame: 18 months
measure: Telemedicine Effectiveness. RE-AIM framework
timeFrame: 18 months
measure: Telemedicine Adoption. RE-AIM framework
timeFrame: 18 months
measure: Telemedicine Implementation.RE-AIM framework
timeFrame: 18 months
measure: Telemedicine Manteinance. RE-AIM framework
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01091896: Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage
Official title: Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage Secondary to Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Vitreous Hemorrhage Secondary to PDR
Keywords: bevacizumab
vitreous hemorrhage
diabetes mellitus
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without bevacizumab injection.

Detailed description: Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. We believe that preoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery

Eligibility criteria: Inclusion Criteria:

* patients undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy

Exclusion Criteria:

* follow-up period of less than 3 months
* not first vitrectomy
* abnormal blood coagulation
* uncontrolled hypertension

Primary outcomes:
measure: Recurrent vitreous hemorrhage incidence after vitrectomy
timeFrame: 3 months
Secondary outcomes:
measure: Visual outcome
timeFrame: 3 months
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas de Ribeirão Preto - University of São Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Felipe Almeida, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tonello M, Costa RA, Almeida FP, Barbosa JC, Scott IU, Jorge R. Panretinal photocoagulation versus PRP plus intravitreal bevacizumab for high-risk proliferative diabetic retinopathy (IBeHi study). Acta Ophthalmol. 2008 Jun;86(4):385-9. doi: 10.1111/j.1600-0420.2007.01056.x. Epub 2007 Nov 7.
Clinical trial NCT01983696: The Effect of Low Oxygen Tension on the Early Development of Human Embryo in IVF/ICSI
Official title: The Effect of Low Oxygen Tension on the Early Development of Human Embryo in IVF/ICSI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Embryo Hypoxia
Keywords: low oxygen tension
embryo quality
Lead sponsor: Shanxi Provincial Maternity and Children's Hospital
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of low oxygen tension during in vitro culture in terms of embryo quality and outcomes of pregnancy in vitro fertilization/ Intracytoplasmic sperm injection

Detailed description: The oocytes will be divided into two parts(two groups) form one patient. The two groups of oocytes will be cultured seperately in the incubator with the concentrations of 5% CO2,6%O2,89% N2(low oxygen concentration) verse 6% CO2,20% O2,74% N2(in atmosphere).

A series of observational measurement(embryo quality and outcomes of pregnancy) will be performed.

Eligibility criteria: Inclusion Criteria:

* Fresh cycles of in vitro fertilization/intracytoplasmic sperm injection and emrbyo transfer (IVF/ICSI-ET)
* ≥ 10 oocytes after oocyte retrieval

Exclusion Criteria:

* ≥ 3 transfer or oocyte retrieval cycles
* PGD/PGS cycles
* half-ICSI/rescure ICSI
* fluid in the uterine cavity, abnormal endometrium, uterine abnormalities,pelvic inflammation
* acute maternal problems.
* One or both spouses have an abnormal karyotype (including polymorphism)

Primary outcomes:
measure: embryo quality
timeFrame: up to 6 days after fertilization
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Maternal and Child Health Care Hospital
state: Shaanxi
Study officials:
affiliation: Maternal and Children Health Care Hospital
name: Wenhao Shi, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT06440096: Complete Blood Count-derived Indexes in Inflammatory Modic Changes
Official title: Harran University Hospital Department of Physical Medicine and Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Modic Changes
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female patients with type I or type II Modic changes, aged ≥18 and ≤64 years old

Brief summary: Some indicators generated from hemogram such as neutrophil/lymphocyte (NLR) have been suggested as biomarkers of systemic inflammation. Type I Modic changes (MCs) have inflammatory nature histologically and are more painful clinically than type II MCs. Therefore, we hypothesized that patients with type I MCs may have increased inflammatory biomarkers and low back pain than those with type II MCs. The aim of this study was to test this hypothesis.

Detailed description: Patients and Methods: A total of 48 patients with MCs (type I/type II=24/24) were included in this study. Their demographic, clinical and hematologic characteristics were recorded. A 10 cm Visual Analog Scale (VAS) was used to detect low back pain intensity. Systemic inflammatory biomarkers including NLR, monocyte/lymphocyte (MLR), platelet/lymphocyte (PLR), neutrophil/lymphocyte\*platelet (NLPR), systemic inflammatory index (SII), systemic inflammatory response index (SIRI), and aggregate index of systemic inflammation (AISI) were derived from whole blood cell count.

Keywords: Neutrophil-to-lymphocyte ratio, inflammation, Modic changes, back pain.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were male or female with type I or type II MCs, aged ≥18 and ≤64 years old, and accepted informed consent to participation.

Exclusion Criteria:

* type III MCs and a combination of MCs' types were excluded. In addition, acute low back pain, spinal deformities, inflammatory diseases, cancers, heart diseases, stroke, lactation, pregnancy, psychiatric disorders, and extreme obesity (BMI≥40 kg/m²) were also excluded.

Primary outcomes:
measure: Hemogram-derived inflammation indexes
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Harran University Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Şanlıurfa
Study officials:
References:
Clinical trial NCT02559596: Reactivation of Varicella Zoster Virus and Risk of Vascular Disease
Official title: Reactivation of Varicella Zoster Virus and Risk of Vascular Disease in the Health Survey for England: a Nested Case Control Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Varicella Zoster
Stroke
Transient Ischaemic Attack
Acute Myocardial Infarction
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be drawn from adults who have already participated in the Health Survey for England between 2009 and 2013 and who have a stored serum sample available for analysis. No new participants will be recruited.

Brief summary: The purpose of this study is to investigate whether there is an association between stroke or heart attack and reactivation of varicella zoster virus, measured by antibody levels, using linked data from the Health Survey for England and secondary care.

Detailed description: This study will use a case control design to investigate whether adult participants in the Health Survey for England between 2009 and 2013 who were admitted to hospital with either a stroke or heart attack had higher preceding levels of varicella zoster virus antibodies measured in stored serum samples compared to matched controls with no history of heart attack or stroke, controlling for a range of potential demographic, lifestyle and clinical confounders.

This study is funded by the University College London Hospitals Biomedical Research Centre Fast Track grant scheme and has received ethics approval (ref 15/NW/0456).

Eligibility criteria: Inclusion Criteria:

* Previous participant in the HSE between 2009 and 2013 with stored serum available.
* Either a record of stroke or TIA or MI in linked HES data between 01/01/2009 and 31/12/2013 or selected as a matched control for those with a record of stroke/ TIA/MI in HES data.
* Male or female, aged 16 years or above.

Exclusion Criteria:

* HSE participant with no stored serum sample

Primary outcomes:
measure: Odds ratio for the effect of high serum antibody titre on stroke or other vascular outcomes
timeFrame: Outcome assessed within 5 years of serum sample
Secondary outcomes:
measure: Prevalence of age- and sex-specific serum VZV antibody titres as a marker for virus reactivation
timeFrame: Assessed at baseline recruitment to the HSE
Other outcomes:
Locations:
Study officials:
affiliation: UCL
name: Charlotte Warren-Gash, MRCP PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05072496: Study on Antibody Persistence and Immune Memory of Inactivated COVID-19 Vaccine
Official title: A Prospective Cohort Study on Antibody Persistence and Immune Memory After Two Doses of Inactivated COVID-19 Vaccine in 150 People
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Inactivated vaccine
cohort study
Antibody persistence
cellular immunity
Lead sponsor: Centers for Disease Control and Prevention, China
Sponsor class: OTHER_GOV
First posted: 2021-10-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The healthy people aged between 18 and 59, and have not been infected with COVID-19, have not been vaccinated with COVID-19 vaccine, and agree to collect blood samples.

Brief summary: The study describe 1 year durability of humoral and cellular immune responses in 150 individuals who received COVID-19 inactivated vaccine. all participants were recruited aged between 18 and 59 years old. Every participant was familiarized with the aim of the study and asked to sign an informed consent agreement, and be required blood sampling at the day 0 of first dose vaccine and 1 month, 3 months, 6 months and 12 months after fully vaccination separately. From every sample, 10 ml, 10 ml, and 5 ml were dispensed in three vacuum blood collection tubes. Peripheral blood lymphocytes cell (PBMC) were isolated with the two 10 ml samples contained heparin to detect immune memory cells and cytokines. RBD-IgG and neutralizing antibody be detected by 5ml sample from separating gel vacuum tubes. every individual conducted a detailed analysis comparing neutralizing antibody, TEM, TCM , and report on the cellular and humoral immunity 1 year after accept COVID-19 vaccine.


Eligibility criteria: Inclusion Criteria:

* Working at the CDC
* Between the ages of 18 and 59
* Healthy
* Not vaccinated with COVID-19 vaccine
* Agreed to take a blood sample

Exclusion Criteria:

* who cannot take the COVID-19 vaccine due to some personal reasons
* history of SARS-CoV, SARS-CoV-2, or Middle East respiratory syndrome infection
* high-risk epidemiology history within 14 days before enrolment (eg, travel or residence history in communities with case reports, or contact history with someone infected with SARS-CoV-2)
* axillary temperature of more than 37·0℃
* history of allergy to any vaccine component.

Primary outcomes:
measure: Durability of humoral and cellular immune responses
timeFrame: 12 months after fully vaccination
Secondary outcomes:
measure: The dynamic variation of the level of antibody
timeFrame: 1，3，6 , 12 month
measure: Cytokine secretion by peripheral blood mononuclear cells
timeFrame: 1,3,6,12 month
measure: TCM and TEM amount varies at different time points
timeFrame: 1,3,6,12 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Center for Disease Control and Prevention
Study officials:
References: