linjc16/ctgov huggingface dataset:
Depression Study In Elderly Patients

Study Overview
=================
Brief Summary
-----------------
Major Depressive Disorder (MDD) Study in Elderly Outpatients

Official Title
-----------------
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Fixed Dose Study Evaluating the Efficacy and Safety of Paroxetine CR in Elderly Outpatients Diagnosed With Major Depressive Disorder

Conditions
-----------------
Depressive Disorder, Major, Major Depressive Disorder (MDD)

Intervention / Treatment
-----------------
* Drug: Paroxetine CR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Major Depressive Disorder (MDD). Current major depressive episode at screen at least 2 months duration. Must be at least 60 years of age. Exclusion Criteria: Patients with a primary diagnosis other than MDD. Patients with a history of schizophrenia, schizoaffective disorder, bipolar disorder or dementia. Patients with a history of brief depressive episodes lasting less than 8 weeks. Patients receiving formal psychotherapy within 12 weeks of study. Patients who are suicidal. Patients who have received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening. Patients with a history or seizure disorders.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Paroxetine CR|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to the week 10 last observation carried forward endpoint in the 17-item HAM-D total score. |  | 10 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in HAM-D item 1; Mean change from baseline in the CGI severity of illness score at study endpoint; Percentage of patients with HAM-D total score less than or equal to 7. |  | 10 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly, Major Depressive Disorder, MDD
Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale

Study Overview
=================
Brief Summary
-----------------
Patent foramen ovale arises from the incomplete postnatal fusion of the septum primum and secundum and can cause paradoxical embolism in adults. In case of cerebral ischemic stroke, the correlation with the patent foramen ovale is based on probabilistic approach. For this reason, continuous research is indispensable, especially according to new approaches, to offer tools capable of guiding in case of adverse event with greater certainty and even better to prevent it. Thus, this study aims to: 1) evaluate the microstructural brain damage through advanced MRI analysis in patients with patent foramen ovale; 2) evaluate how much the degree of the shunt can affect brain damage. In order to do this, this study aims to evaluate advanced brain imaging in a cohort of patients with patent foramen ovale to identify the development of early vascular damage.

Official Title
-----------------
Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale

Conditions
-----------------
Patent Foramen Ovale

Intervention / Treatment
-----------------
* Other: No interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 and ≤ 65 years patients with patent foramen ovale written informed consent Exclusion Criteria: previous IMA, stroke or TIA arrhythmia or severe cardiac disease hypertension, diabetes or renal disease psychiatric disease neurological or neurodegenerative disease dementia assumption of drugs known to interfere with cognitive function inability to be subjected MRI analysis participation to other clinical trial, ongoing or terminated less than one month before enrolment in this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Patent Foramen Ovale<br> | Other: No interventions<br>* No interventions - observational study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of percentage change in diffusion parameters of the white matter | Fiber tracking by DTI MRI | At Enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of the degree of shunt of the patent foramen ovale | Echography | At Enrollment | 
| Detection of cognitive decline by decrease of MoCA score | Cognitive tests | At Enrollment | 
| Detection of a non-invasive retinal screening | Digital ophthalmoscope | At Enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic Resonance Imaging, Vascular Cognitive Impairment
Estimated VO2Max Validation

Study Overview
=================
Brief Summary
-----------------
In this study, the hypothesis being explored is that VO2Max and other CPET parameters can be accurately estimated from biosignals (namely, motion from accelerometers and cardiopulmonary variables from EKG) collected during activities of daily living using wearable biosensors worn by study participants. This study will aim to collect development and validation data for a machine learning algorithm and to evaluate the performance of the algorithm. A total of 300 participants will be enrolled including: (Normal) 200 participants, self-reported healthy male and female participants aged 18 to 80 and (Standard of Care) 100 participants

Official Title
-----------------
Validation of VO2Max Estimations Using Healthy and Standard of Care Participants

Conditions
-----------------
Heart Failure, Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has a clinical indication for investigation of functional capacity through cardiopulmonary exercise testing Willing and able to comply with protocol procedures Willing to sign and date informed consent document for study participation Exclusion Criteria: Participant has cognitive or physical limitations that, in the opinion of the investigator, limits the participant's ability to fully follow study procedures and/or reach and respiratory exchange ratio of 1.0 Participant has an allergy to the adhesive used on the VitalPatch Participant is pregnant, lactating or 30 days post-partum

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy<br> | |
| Standard of Care<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect development and validation data for a VO2Max (eVO2Max) machine learning algorithm and to evaluate the performance of the algorithm. | Develop an Estimated VO2Max (eVO2Max) algorithm which will estimate a participant's VO2Max value using data collected from physiological wearable biosensors (ECG & Activity). This estimation algorithm will be developed using a portion of the collected data (physiological biosignals + CPET) from healthy participants and a portion of data from a separate cohort with a clinical indication requiring functional capacity evaluation (called the Standard of Care Cohort). | August, 2023 |
Intra-operative (IO) Navigation and IO-CBCT for 3D Orbital Reconstruction

Study Overview
=================
Brief Summary
-----------------
Background Correction of post traumatic and post-ablative orbita defects remains a challenge for the maxillofacial surgeon. The purpose of such intervention is the restoration of both function and aesthetics by anatomical reconstruction of the bony orbitawalls, with attention to the orbitavolume. Unfortunately, the results of such interventions today are still somewhat unpredictable. The aim of this study is to determine whether 3D virtual planning combined with intra-operative navigation can increase the predictability of the outcome in function and aesthetics. Study design Retrospective study. Demographic data, diagnostic and surgical parameters will be collected of all patients undergoing orbital surgery between 01/01/2012 and 31/12/2016 at the department. Pre- en postoperative orbit volume will be determined based on CT-analysis in Brainlab software, and compared to the non-defected orbit.

Official Title
-----------------
Intra-operative (IO) Navigation and IO-CBCT for 3D Orbital Reconstruction in Post-traumatic and Post-ablative Defects. Evaluation of the Potential of a Fully Integrated Brainlab Iplan System.

Conditions
-----------------
Orbital Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
inclusion criteria patients of all genders patients of all ages patients undergoing surgery for orbit fractures between 01/01/2012 until 31/12/2016
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| intra-operative CBCT<br> | |
| 3D virtual planning + intra-operative navigation<br> | |
| 3D virtual planning + intraoperative navigation + IO CBCT<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of orbital volume reconstruction, as measured in Brainlab |  | immediate postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intra-operative navigation, 3D virtual planning, intra-operative cone beam computed tomography (CBCT)
Effect of Vitamin D Supplementation on Vedolizumab Response in Patients With Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
It is uncertain whether vitD3 supplementation is beneficial for the remission of ulcerative colitis (UC). The effects of vitD3 supplements on the efficacy of vidrecizumab in Chinese UC patients were retrospectively analyzed. Methods: Patients with moderate to severe UC were recorded. These patients were initially treated with VDZ. VitD3 supplementation was defined as 400IU/d vitD3 supplementation during the first infusion of VDZ and continued throughout the follow-up period. Disease activity was assessed using the modified Mayo score.

Official Title
-----------------
Retrospective Analysis of the Effect of Vitamin D Supplementation on the Clinical Efficacy of Vedelizumab in Ulcerative Colitis Patients

Conditions
-----------------
Ulcerative Colitis, Vitamin D Deficiency, Vitamin D Supplement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate-to-severe UC Treated with Vedolizumab Exclusion Criteria: had recent supplementation of vitD3 pregnant had cognitive/developmental disorders that affected their ability to complete the study procedures had medical illness or therapies potentially affecting bone, nutrition or growth status unknown or untested baseline serum 25(OH)D level

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| supplementary group<br>take vitamin D supplementation (400 IU/day) during VDZ treatment | |
| non-supplementary group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum 25 (OH) D level | Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status. | 30 weeks | 
| disease activity | modified Mayo score，mild: 3 to 5, moderate: 6 to 10, severe: 11 to 12 | 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| drug survival | Proportion of UC patients who continued to receive VDZ | 54 week |
Project SHARE (motherS Have All the Right microbEs)

Study Overview
=================
Brief Summary
-----------------
This is an exploratory study designed to collect microbial samples from several body locations from 6 pairs of mothers and their newborn infants at various time points.

Official Title
-----------------
An Exploratory Study to Evaluate the Transfer of the Maternal Microbial Consortia to Infants During and Following Birth

Conditions
-----------------
Microbiota

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mother- pregnant female, singleton infant Infant- vaginal birth, breastfeeding as primary source of nutrition Exclusion Criteria: Mother- antibiotic, steroid or antimicrobial use Infant- antibiotic, steroid or antimicrobial use
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mother infant pair<br>mother infant pair, singleton infant, vaginal birth | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal staphylococci is transferred to infant during and following birth. | presence of maternal staphylococci strain in infant | 6 weeks |
Confirmatory Study of NeoCart in Knee Cartilage Repair

Study Overview
=================
Brief Summary
-----------------
This confirmatory study is a prospective randomized trial comparing the efficacy and safety of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention microfracture in the treatment of cartilage defects in the knee.

Official Title
-----------------
A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee

Conditions
-----------------
Articular Cartilage Defects in the Knee Joint

Intervention / Treatment
-----------------
* Biological: NeoCart
* Procedure: Microfracture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: greater than 18 years old symptomatic articular cartilage lesion of the femur and/or trochlea Exclusion Criteria: prior surgical intervention other than debridement arthritis clinically significant or symptomatic vascular or neurologic disorder of the lower extremities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeoCart<br>Autologous cartilagenous tissue implant | Biological: NeoCart<br>* implantation of an cartilagenous tissue implant derived from the patients own cells.<br>|
| Active Comparator: Microfracture<br>surgical intervention | Procedure: Microfracture<br>* holes are created in bone at the base of the defect bed to encourage growth of tissue within the defect bed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of physical functioning and pain as assessed by patient reported outcome measures (Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score) |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repair cartilage structure as measured by magnetic resonance imaging (MRI) |  | one year |
Compound to Control Presbyopia Symptoms

Study Overview
=================
Brief Summary
-----------------
Low dose compose to control presbyopia symptoms

Detailed Description
-----------------
A los dose compound including pilocarpine, brimonidine and oxymetazoline was use to control presbyopia symptoms compared to pilocarpine and brimonidine in low doses.

Official Title
-----------------
Synergistic Use of Pilocarpine-Brimonidine-Oxymetazoline to Control Presbyopia Symptoms

Conditions
-----------------
Presbyopia

Intervention / Treatment
-----------------
* Combination Product: PBO to control presbyopia symptoms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy Presbyopic 40 - 59 years Exclusion Criteria: Diabetics Previous eye surgery Previous eye disease > 0.50 myopia > 1.5 hyperopia or astigmatism

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilocarpine, brimonidine, oxymetazoline (PBO) compound was instilled in the non-dominant eye of presbyopic patients, while in the dominant eye pilocarpine or brimonidine were instilled.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PBO Investigational drug<br>Pilocarpine, brimonidine, oxymetazoline combined with hyaluronic acid and bromfenac combined in an ophthalmic solution to be randomly instilled in one eye. | Combination Product: PBO to control presbyopia symptoms<br>* Low dose PBO to control presbyopia symptoms<br>* Other names: Oxymetazoline;|
| Active Comparator: Pilocarpine<br>Pilocarpine was instilled in the other oye. | Combination Product: PBO to control presbyopia symptoms<br>* Low dose PBO to control presbyopia symptoms<br>* Other names: Oxymetazoline;|
| Active Comparator: Brimonidine<br>Brimonidine was instilled in the other eye. | Combination Product: PBO to control presbyopia symptoms<br>* Low dose PBO to control presbyopia symptoms<br>* Other names: Oxymetazoline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jaeger notation near uncorrected visual acuity change | Number of lines improved 1 hour after drug instillation | 1 hour | 
| Comparison of PBO compound Jaeger notation improvement vs Pilocarpine or Brimonidine alone | Number of lines improve comparing PBO compound vs Pilocarpine or Brimonidine | 1 hour |
Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of recombinant human growth hormone on adult growth hormone deficiency

Official Title
-----------------
Phase III of the Comparative Study on the Efficacy and Safety of Recombinant Somatropin Administered to Patients With Adult Growth Hormone Deficiency

Conditions
-----------------
Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: somatropin
* Drug: Eutropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 and up Patients with maximum serum growth hormone concentration of less than 5 ng/ml Patients who can successfully complete this study based on appropriate medical judgment or who expect to benefit from this study Persons who have agreed in writing to participate in this study Exclusion Criteria: Persons who are currently under treatment after being diagnosed with a malignant tumor Hepatosis Renal function disorder Intra-cranial hypertension Proliferative diabetic retinopathy Persons who carry acromegaly activity Fertile women who are not pregnant or who do not take appropriate contraceptive measures and whose urine tested positive for hCG (human Chorionic Gonadotropin) Mental patients and/or drug addicts and alcoholics Patients who had participated in the other drug study within the last 30 days prior to participating in this study Patients considered unfit for this study by the attending physician

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: somatropin<br>Subcutaneous injection | Drug: somatropin<br>* Subcutaneous injection<br>|
| Active Comparator: Eutropin<br>Subcutaneous injection | Drug: Eutropin<br>* Subcutaneous injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of fat mass (FM) reduction | statistically difference for change from baseline (kg) | baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of variation in Lean Body Mass | statistically difference for change from baseline (kg) | baseline and 24 weeks | 
| Degree of variation in Waist to Hip Ratio | statistically difference for change from baseline | baseline and 24 weeks | 
| Degree of variation in IGF-1 | statistically difference for change from baseline (ng/ml) | baseline and 24 weeks |