louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01306487: Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery
Official title: Correlation Between Visual Acuity and Recovery of Foveal Cone Microstructures After Macular Hole Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Holes
Keywords: macular hole
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2011-03-02
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with surgically-closed MHs after successful vitrectomy

Brief summary: The objective is to determine whether a recovery of the microstructures of the foveal photoreceptors after macular hole (MH) closure is correlated with the best-corrected visual acuity (BCVA) is determined.

Detailed description: Macular hole patients were evaluated by spectral domain optical coherence tomography (SD-OCT) to determine the integrity of the microstructures of the foveal photoreceptors. The inner segment/outer segment (IS/OS) junction, the external limiting membrane (ELM), and the cone outer segment tips (COST) line were determined preoperatively, and at 1, 3, 6, 9, and 12 months after the MH surgery. The correlation between the integrity of the foveal photoreceptor microstructures and the best-corrected visual acuity (BCVA) was determined.

Eligibility criteria: Inclusion Criteria:

* The patients had undergone surgery from March 2008 to August 2009 at Kyorin Eye Center
* Idiopathic macular hole patients with either a Stage 2, 3, or 4 according to the Gass classification

Exclusion Criteria:

* The presence of other retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy
* High myopia with an axial length \> 27.0 mm or refractive error \> -8.0 diopters
* The patients followed for less than 6 months postoperatively

Primary outcomes:
measure: Foveal microstructure determined by optical coherence tomography
timeFrame: Preoperative and postoperative 1, 3, 6, 9, 12 months
Secondary outcomes:
measure: The visual acuity
timeFrame: Preoperative and postoperative 1, 3, 6, 9, 12 months
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Kyorin Eye Center
state: Tokyo
Study officials:
References:
Clinical trial NCT02674087: Prospective Monitoring of Children Born in Haute Vienne From Uterine Life to Adulthood
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Development
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: Fondation Patrtenariale Unilim
name: ARS
name: La poste
First posted: 2016-02-04
Enrollment: 9000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Expectant mother

Brief summary: The purpose of this survey is to collect data from intrauterine life until the age of 18 of children born in Haute Vienne.

The interest to realize such survey is to find correlations and interactions that may exist between the events that occurred during intrauterine life and those that will occur after the birth of the child. The investigators will examine every aspect of these children's lives from the perspectives of health, social sciences and environmental health

These are medical events (occurrence of disease, medication), but also socio-cultural for this child (living environment, exposure to possible contaminants, events in family history).

This cohort aims to include 3000 children a year (whose parents consented to their inclusion), all born at Haute-Vienne.


Eligibility criteria: Inclusion Criteria:

* Any child born in one of the three maternity hospitals in the Haute-Vienne (CHU Limoges, Clinique des Emailleurs, Hospital Saint-Junien).
* Any child who's parents consented to their inclusion.

Exclusion Criteria:

* Children born at home.
* Children abandoned at birth.

Primary outcomes:
measure: Rate of enrollment
timeFrame: At 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Clinique des Emailleurs
city: Limoges
country: France
facility: HME
city: Saint Junien
country: France
facility: Centre Hositalier de Saint Junien
Study officials:
References:
Clinical trial NCT01829087: Botulinum Toxin A to Treat Flexion Contracture After Total Knee Arthroplasty
Official title: Botulinum Toxin A to Treat Flexion Contracture After Total Knee Arthroplasty: A Double-Blinded Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Flexion Contracture Following Total Knee Replacement
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
Collaborators: name: Sharpe-Strumia Research Foundation
First posted: 2013-04-11
Enrollment: 140
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 goal of this research project is to evaluate injections of botulinum toxin A (Botox) as the treatment for knee flexion contracture after total knee arthroplasty (TKA). The current treatment for patients who do not achieve full extension of the knee (flexion contracture) after TKA consists of an aggressive physical therapy program, home stretching program, and the use of an extension orthosis (brace). Many patients do not tolerate wearing these braces. This initial project is designed to use injections of Botox as an adjunct to the standard current treatment and evaluate its efficacy. It is our hypothesis that a single injection into the hamstrings in addition to routine postoperative rehabilitation will result in improved knee extension and this improvement in function should endure without further treatment.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age
* Subject had a total knee replacement or total knee replacement revision surgery performed at Main Line hospitals such as Bryn Mawr Hospital, Lankenau Hospital, and Riddle Hospital
* Subject is measured to have at least 10 degree flexion contracture of the operative knee four to six weeks following surgery
* Subject has the willingness to complete scheduled follow up evaluations as described in the informed consent

Exclusion Criteria:

* Subject is currently involved in another study or has received investigational product or treatment within the last 30 days
* Subject is a prisoner
* Subject is anticipated to be non-compliant
* Subject is known to be pregnant
* Subject is mentally incompetent or unable to understand what participation in the study entails
* The subject has a known sensitivity or allergic reaction to Botulinum Toxin A and albumin
* The subject is unwilling or unable to give consent or to comply with the follow up program

Primary outcomes:
measure: Range of Motion: knee
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bryn Mawr
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Lankenau
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01351987: An Observational Study of Dutasteride and Alpha-blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL
Official title: An Observational Study of Dutasteride and Alpha-Blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2011-05-11
Enrollment: 855
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Benign Prostatic Hyperplasia male paitents

Brief summary: To analyze the change in International Prostate Symptom Score (IPSS) and serum prostate-specific antigen (PSA) level from baseline.

Detailed description: This is a non-interventional, observational and multicenter study. When subjects will be allowed the dutasteride and α-blocker orally once daily for two years by investigator's prescription. They will be invited to this observational study. All eligible subjects can be allowed the prior alpha blockers therapy. Details of acute urinary retention (AUR) and BPH-related prostatic surgery episodes will be recorded at every visit. Subjects will return to the clinic for assessment every 3 months until week 96. The efficacy and safety of combining the 5α-reductase inhibitor (5ARI), dutasteride, and the α-blocker will be assessed.

Eligibility criteria: Inclusion Criteria:

* Males, age ≧ 50 years
* Clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE)
* IPSS score ≧ 8 points and prostate volume ≧ 30 mL
* Total serum PSA ≧ 4.0 ng/mL and ≦ 20 ng/mL at screening
* Previous TRUS-guided biopsy have been done with benign findings and with prostate cancer (CaP) not detected within the past 6 months.
* Dutasteride combination therapy will be allowed by investigator's prescription
* Ability to understand and willingly provide written informed consent

Exclusion Criteria:

* History or evidence of prostate cancer and high grade prostatic intraepithelial neoplasia (HGPIN)
* With symptomatic urinary tract or prostate infection or urinary retention within 3 months prior to entry of study
* Use of finasteride within 6 months of screening visit
* Use of dutasteride within 12 months of screening visit

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University - WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Liang-Ming Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06012487: Correlates and Control of Blood Pressure Variability
Official title: Correlates and Control of Blood Pressure Variability
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Blood Pressure Variability
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a feasibility study of the feasibility of helping physicians select a protocol to reduce BPV in hypertensive patients on antihypertensive therapy. The duration of the study for Aim 2 is 2 visits, the first with a 48 hour ABPM and the second for a repeat 48 hour ABPM following any changes made at the discretion of the treating provider.

The optional sub-study is also a feasibility study, designed to demonstrate the ability to simultaneously capture ABPM and SKNA data.
Primary purpose: DIAGNOSTIC

Brief summary: The purpose the research is to prospectively demonstrate agreement between EHR and ambulatory blood pressure monitor (ABPM) derived blood pressure variability (BPV), as well as the feasibility of reducing BPV using a data-driven pharmacotherapeutic approach. To this end, this is a feasibility study that will make use of the Cedars-Sinai Health System including the Medical Delivery Network and the clinics of all practitioners who use the same EHR.

Detailed description: The primary research procedures are: assessment of blood pressure variability (BPV) using ABPM compared to EHR derived values; and to assess feasibility of a data driven pharmacotherapy intervention to reduce BPV among high BPV patients. As part of an option sub-study, participants may wear a single lead ECG patch to record skin sympathetic nerve activity (SKNA), which has been previously correlated with changes in blood pressure.

Eligibility criteria: Inclusion Criteria:

* Individuals 18 years old or older are included.
* Patients followed continuously at Cedars-Sinai for at least 5 years, defined as at least 1 outpatient visit with a Cedars-Sinai physician at which a blood pressure was measured each of the last 2 calendar years
* Patients with a PCP in the Cedars-Sinai Medical Group or faculty practice
* Patients on antihypertensive therapy other than a DPH-CCB or thiazide-like diuretic
* Patients in the highest decile of BPV based on extracted BP data from the EHR

Exclusion Criteria:

* Any records flagged "break the glass" or "research opt out."
* Pregnant or breastfeeding patients (due to guideline recommendations for specific medications for the treatment of hypertension during pregnancy and breastfeeding).

Primary outcomes:
measure: Change in Blood Pressure Variability
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03138187: Physical Exercise and Energy Balance
Official title: Effect of Physical Exercise Intensity on Spontaneous Physical Activity Energy Expenditure and Energy Intake in Overweight Adults: a Study Protocol for a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: spontaneous physical activity
caloric intake
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized controlled trial, designed to evaluate the effect of structured physical exercise sessions on the spontaneous physical activity energy expenditure and caloric intake in overweight adults. The design employs a parallel three-group experimental arms: (1) a moderate exercise group (MEG); (2) a vigorous exercise group (VEG); and a control group (CG) without physical exercise sessions.


Eligibility criteria: Inclusion Criteria:

1. male
2. overweight

Exclusion Criteria:

1. diabetes mellitus
2. cardiovascular diseases
3. musculoskeletal injuries

Primary outcomes:
measure: spontaneous physical activity energy expenditure
timeFrame: 15 days
Secondary outcomes:
measure: appetite sensations
timeFrame: 15 days
measure: energy intake
timeFrame: 15 days
measure: laboratorial biomarkers
timeFrame: 15 days
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Naval Academy
Study officials:
References:
citation: Paravidino VB, Mediano MFF, Crochemore-Silva I, da Cruz VL, Antunes MML, Beaulieu K, Gibbons C, Finlayson G, Blundell JE, Sichieri R. The compensatory effect of exercise on physical activity and energy intake in young men with overweight: The EFECT randomised controlled trial. Physiol Behav. 2021 Feb 1;229:113249. doi: 10.1016/j.physbeh.2020.113249. Epub 2020 Nov 20.
citation: Paravidino VB, Mediano MFF, Silva ICM, Wendt A, Del Vecchio FB, Neves FA, Terra BS, Gomes EAC, Moura AS, Sichieri R. Effect of physical exercise on spontaneous physical activity energy expenditure and energy intake in overweight adults (the EFECT study): a study protocol for a randomized controlled trial. Trials. 2018 Mar 7;19(1):167. doi: 10.1186/s13063-018-2445-6.
Clinical trial NCT05281887: Correlation Between the Changes of Retinal Structure and Function and Ischemic Stroke
Official title: Correlation Between the Changes of Retinal Structure and Function and Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Keywords: Ischemic Stroke
retinal
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 120
Sex: ALL
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: ischemic stroke

Brief summary: Ischemic stroke is the most common type of stroke, accounting for 60%-80% of all types of strokes, and is one of the leading global causes of death and severe disability. In the risk factors of stroke, carotid atherosclerosis have higher incidence.As the only visible microvessels in vivo, retinal can provides an accurate window into cerebrovascular and systemic vascular conditions. Optical coherence tomography angiography (OCTA) and electroretinogram (ERG) can be used to quantitatively analyze the retinal structure and function in patients with ischemic stroke, and find out the valuable parameters. Electroencephalogram(EEG) can collect the electrical activity of cerebral cortex in patients with ischemic stroke and find the correlation between EEG and ERG. Finally, it is of great significance to establish a non-invasive, more objective, convenient and safe risk prediction model for stroke in combination with carotid atherosclerosis, retinal structural and functional parameters and EEG.

Detailed description: Firstly, this study will cross sectional analyze the retinal structure and function of patients with ischemic stroke to find the closely related parameters. Secondly, based on the results of cross section analysis, a cohort study will be established to build a risk prediction model for stroke combining carotid atherosclerosis, retinal structure and function parameters and EEG.

Eligibility criteria: Inclusion Criteria:

* Patients with ischemic stroke

Exclusion Criteria:

* Refractive interstitial turbidity affect the examination results
* Any retinal diseases
* Other causes of ischemic stroke (cardiogenic embolism, dissection aneurysm, hemagglutination disorder, polycythemia, vasculitis, vascular malformation, etc.)
* Fails to complete an ophthalmic examination or the follow-up

Primary outcomes:
measure: Optical coherence tomography angiography (OCTA)
timeFrame: 1year
measure: Electroretinogram (ERG)
timeFrame: 1year
Secondary outcomes:
Other outcomes:
measure: Electroencephalogram(EEG)
timeFrame: 1year
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Qianli Meng
role: STUDY_DIRECTOR
References:
Clinical trial NCT05657587: Treatment of Shoulder Osteoarthritis
Official title: A Post Market Observational Case Series Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Chronic Shoulder Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Shoulder Pain
Lead sponsor: Gramercy Pain Center
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pain due to degenerative changes in the shoulder scheduled for commercial placement of the Sprint PNS system

Brief summary: The purpose of this study is to learn if pain can be relieved by delivering small amounts of electricity ("electrical stimulation") to the nerves relaying sensory information to the shoulder. This study will use a device called Sprint PNS system. PNS stands for Peripheral Nerve Stimulation. This device is cleared by the FDA for up to 60 days of use for relief of chronic or acute pain.


Eligibility criteria: Key Inclusion Criteria:

* Diagnosed with degenerative changes within the shoulder complex

Key Exclusion Criteria:

* Pain exclusively in the anterior aspect of the shoulder
* Opioids for any condition other than shoulder pain
* Other implanted electronic device

Primary outcomes:
measure: Reduction in average pain and/or reduction in pain interference
timeFrame: 15 days, 1 month, 2 months, 3 months, 6 months, and 12 months post Start of Treatment
Secondary outcomes:
measure: Changes in pain intensity
timeFrame: baseline, start of treatment (lead placement); 15 days, 1 month, 2 months, 3 months, 6 months, and 12 months post Start of Treatment
measure: Changes in pain interference
timeFrame: baseline, start of treatment (lead placement); 15 days, 1 month, 2 months, 3 months, 6 months, and 12 months post Start of Treatment
measure: Range of motion of the shoulder
timeFrame: baseline, start of treatment (lead placement); 2 months, 3 months, 6 months, and 12 months post Start of Treatment
measure: Changes in Shoulder Function
timeFrame: baseline, start of treatment (lead placement); 15 days, 1 month, 2 months, 3 months, 6 months, and 12 months post Start of Treatment
Other outcomes:
Locations:
city: Holmdel
country: United States
facility: Gramercy Pain Center
state: New Jersey
Study officials:
References:
Clinical trial NCT01364987: Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Mycophenolate Mofetil in Healthy Volunteers
Official title: A Phase 1, Open Label, Single Sequence, Drug Interaction Study of the Pharmacokinetics of ASP015K and Mycophenolate Mofetil (MMF) After Separate and Concomitant Administration to Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Drug Interactions
Pharmacokinetics of ASP015K
Keywords: transplant
ASP015K
healthy subjects
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study characterizes the pharmacokinetic effect of ASP015K on mycophenolate mofetil in healthy volunteers.

Detailed description: The subjects will be confined to the unit for 13 days and have a brief follow-up visit to obtain hematology blood samples. Numerous blood and urine samples will be taken to determine the pharmacokinetics of the drugs.

Eligibility criteria: Inclusion Criteria:

* If female, the subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
* If male, the subject agrees to sexual abstinence and/or to use a highly effective method of birth control during the study period
* Subject is medically healthy, with no clinically significant medical history or abnormalities
* Subjects must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2

Exclusion Criteria:

* Subject has a history of chronic diarrhea
* Subject has been vaccinated within the last 60 days prior to study drug administration
* The subject has a previous history of any clinically significant neurological, gastro-intestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, and hematological disorder or disease
* Subject has a positive test for hepatitis C antibody, or positive for hepatitis B surface antigen (HBsAg)
* Subject has a history of the human immunodeficiency virus (HIV) antibody
* The subject has an absolute neutrophil count (ANC) \< 2500 cells/mm3
* Subject has had clinically significant illness within 1 month prior to study drug administration
* Subject has a recent history (within the last 6 months) of drug or alcohol abuse or a positive urine screen for alcohol or drugs of abuse/illegal drugs

Primary outcomes:
measure: Assessment of pharmacokinetic variables through analysis of blood and urine samples
timeFrame: Up to 13 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
Study officials:
affiliation: Astellas Pharma Global Development
name: Medical Director
role: STUDY_DIRECTOR
References: