linjc16/ctgov huggingface dataset:
A Retrospective Study to Investigate Prevalence of Capsular Bag Distention Syndrome and Its Influencing Factors

Study Overview
=================
Brief Summary
-----------------
To Investigate the Prevalence of Capsular Bag Distention Syndrome To Analyze Influencing Factors of Capsular Bag Distention Syndrome

Conditions
-----------------
Capsular Bag Distention Syndrome After Cataract Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent uneventful phacoemulsification and posterior-chamber IOL implantation at the Eye and ENT Hospital of Fudan University, Xuhui, Shanghai, China, between November 2011 and December 2012 Exclusion Criteria: Patients with traumatic cataracts or zonular weakness were excluded from the study, as were eyes with intraoperative complications, such as a posterior capsule opening, radial tearing of the continuous curvilinear capsulorhexis (CCC), or inappropriate IOL implantation.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 90 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dimension of the eyeball(mm) |  | 1 month |
Neural and Cognitive Mechanisms of Depression and Anxiety: a Multimodal MRI Study

Study Overview
=================
Brief Summary
-----------------
To explore the neural and cognitive mechanisms of depression (including unipolar depression and Bipolar disorder) and anxiety using multimodal MRI techniques.

Official Title
-----------------
Neural and Cognitive Mechanisms of Depression and Anxiety: a Multimodal MRI Study

Conditions
-----------------
Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range from 16 to 55 years old. All patients were interviewed by two experienced psychiatrists using the Structured Clinical Interview for DSM-IV (patient edition) Exclusion Criteria: Schizophrenia, mental retardation or personality disorder, any history of loss of consciousness, substance abuse, serious medical or neurological illness. Subjects with contraindications to MRI

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 55 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 control<br>Well mathed with patients in age, gender, education | |
| major depression disorder<br>patients with major depression disorder | |
| anxiety disorder<br>patients with anxiety disorder | |
| bipolar depression disorder<br>patients with bilopar depression disorder | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain structural and functional changes in patients | Structure and function changes in patients will be assessed by Voxel-based morphometry analysis for structural changes, as well as Regional homogeneity, Amplitude of lowfrequency fluctuation, etc, for functional changes. | one time point | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, anxiety disorder, bipolar disorder, Magnetic Resonance Imaging
Ischemic Heart Disease Incidence and Indices of Body-fat Distribution

Study Overview
=================
Brief Summary
-----------------
To determine the association between ischemic heart disease incidence and anthropometric indices of body-fat distribution.

Detailed Description
-----------------
BACKGROUND: Previous studies have demonstrated that abdominal obesity can be predictive of ischemic heart disease. These prospective cohort studies employed simple indices of body-fat distribution such as waist-to-hip circumference ratio or subscapular skinfold. Their similar results suggested that increased abdominal obesity conferred a two-fold increased risk of ischemic heart disease among middle-aged men. The two proposed studies permitted testing of alternative fat-distribution indices which might be stronger risk factors for ischemic heart disease incidence than the waist-to-hip-ratio or the subscapular skinfold. DESIGN NARRATIVE: Two parallel case-control studies were conducted. In both studies, subjects were measured for girth, skinfold, abdominal sagittal diameter, height, and weight. Analyses for both protocols considered men and women separately. Possible confounders of the association between fat-distribution indices and ischemic heart disease were considered and if required, adjusted for in multivariate analyses. Possible confounders included race, age, tobacco use, alcohol use, diabetes, social class, hypertension, cholesterol levels, and physical activity levels. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Outcome of Botulinum Toxin Treatment for Oromandibular Dystonia

Study Overview
=================
Brief Summary
-----------------
Symptoms of oromandibular dystonia can be alleviated by injections of botulinum toxin. The scope of this study is to describe the efficacy of this procedure, by a retrospective systematic review of patients medical charts

Official Title
-----------------
Outcome of Botulinum Toxin Treatment for Oromandibular Dystonia

Conditions
-----------------
Dystonia; Orofacial

Intervention / Treatment
-----------------
* Drug: Botulinum Toxins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient suffering from oromandibular dystonia Medical follow up in the Fondation Ophtalmologique Rothschild (Paris) Treatment by at least one session of botulinum toxin injection Exclusion Criteria: Patient cannot assess symptoms improvement using a Likert scale

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Botulinum Toxins|Injection of botulinum toxin in the muscles affected by oromandibular dystonia|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement score | Likert scale for the assessment of the clinical improvement after treatment | Two months |
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years

Study Overview
=================
Brief Summary
-----------------
Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years

Official Title
-----------------
A Phase III, Clinical Trial Comparing the Immunogenicity and Safety of SmithKline Beecham Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix™-B, in Pre-haemodialysis/Haemodialysis Patients (>=15 Years of Age)

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Biological: Hepatitis B adjuvanted vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female > = 15 years of age at the time of the first vaccination. Written informed consent obtained from the subject/ from the parents or guardians of the subject. Seronegative for anti-HBs antibodies, anti-HBc antibodies & Hepatitis B Surface antigen (HBsAg). If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination. Pre-haemodialysis patient* or a patient on haemodialysis. Exclusion Criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine. Previous vaccination against hepatitis B. History of hepatitis B infection. Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female Clinically abnormal ALT/AST values (> 3 times normal values)

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Hepatitis B adjuvanted vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs seroprotection rates at Month 7. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited symptoms, unsolicited symptoms and serious adverse events |  |  |
Influence of Pneumonia on Delayed Cerebral Ischemia After Subarachnoid Hemorrhage . SAH-CIP (SubArrachnoid Hemorrhage - Cerebral Infarction Pneumonia)

Study Overview
=================
Brief Summary
-----------------
Prognosis of subarachnoid hemorrhage (SAH) is scarce, indeed almost half patients die or become severely disable after SAH. Outcome is related to the severity of the initial bleeding and delayed cerebral infarction (DCI). Infection and more precisely pneumonia have been associated with poor outcome in SAH. However, the interaction between the two pathologic events remains unclear. Therefore, we hypothesized that DCI may be associated to pneumonia in SAH patients. Thus the aim of the study is to analyze the association between delayed cerebral infarction and pneumonia in patients with SAH. Retrospective, observational, monocentric cohort study, including patient admitted in Neurosurgical Intensive Care Unit or Surgical Intensive Care Unit in the University Hospital of Brest (France) for non-traumatic SAH. Primary outcome is diagnosis of DCI on CT scan or MRI 3 months after SAH. Multivariate analysis is used to identify factors independently associated with DCI. We plan to include between 200 and 250 patients in the analysis.

Official Title
-----------------
Influence of Pneumonia on Delayed Cerebral Infarction After Subarachnoid Hemorrhage: a Retrospective Study

Conditions
-----------------
Subarachnoid Hemorrhage, Pneumonia, Bacterial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admitted in ICU in Brest University Hospital for non traumatic subarachnoid hemorrhage between july 2015 and december 2018 Exclusion Criteria: continuation of care out of Brest University Hospital after initial ICU stay refusal to participate
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delayed cerebral infarction | infarction on CT or MRI not related to initial bleeding | 3 months from subarachnoid hemorrhage | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subarachnoid hemorrhage, pneumonia, delayed cerebral ischemia, vasospasm, delayed cerebral infarction
Evaluation of Centration of Intraocular Lens With Two Settings for Capsulorhexis With Femtosecond Laser

Study Overview
=================
Brief Summary
-----------------
The study compares anatomic outcomes of Intra Ocular Lens(IOL) placement with two methods of centration of the capsulorhexis- scanned capsule centration and pupil centration. It is hypothesized that scanned capsule centration provides more uniform(25% better) overlap of capsulorhexis margin over IOL optic compared to pupil centration.

Detailed Description
-----------------
50 consecutive eyes undergoing cataract surgery will be studied. 25 eyes will have scanned capsule centration and 25 will have pupil centration. Retroillumination slitlamp photographs will be taken 10-30 days after surgery with dilated pupils. The amount of capsule overlapping the IOL will be documented. The horizontal, vertical and symmetricity of overlap will be calculated. Each group will have 20 eyes with an additional 5 eyes in each group to account for drop outs or poor quality images.

Official Title
-----------------
Prospective Randomized Evaluation of Centration of Intraocular Lens With Two Laser Settings for Capsulorhexis With Femtosecond Laser

Conditions
-----------------
Capsulorhexis

Intervention / Treatment
-----------------
* Procedure: capsulorhexis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cataracts Same variety of IOL inserted in all eyes Exclusion Criteria: Previous glaucoma or retinal surgery Pupil not dilating beyond 6mm Zonular weakness or pseudoexfoliation Extensive corneal scarring High refractive error: Myopia greater than 10D, Hyperopia greater than 5D

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 95 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Capsule centration<br>Capsulorhexis made with capsule centration | Procedure: capsulorhexis<br> <br> |
| Other: Pupil centration<br>Capsulorhexis made with pupil centration | Procedure: capsulorhexis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overlap of the Continuous Curvilinear Capsulorhexis margin over the IOL | The horizontal and vertical overlap will be calculated. Horizontal overlap= Overlap of the temporal half versus the nasal half Vertical overlap= overlap of the superior half versus the inferior half of the IOL. Symmetricity of overlap= Horizontal overlap/vertical overlap | 10-30 days post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
capsulorhexis, IOL centration
Effect of Beta-Alanine on Heart Rate Response

Study Overview
=================
Brief Summary
-----------------
Beta-alanine, as a method to increase muscle carnosine, has been shown to enhance muscle buffering capacity and delay fatigue. Various fatigue tests have been utilized to examine the effectiveness of beta-alanine supplementation. The physical working capacity test has been used to show significant increases in physical working capacities following supplementation. The physical working capacity tests were originally developed by Moritani et al. 1981 and Devries et al. 1982 to measure the point of onset of muscular fatigue. It is hypothesized that beta-alanine will increase physical working capacity at heart rate threshold, thereby signifying a delay in fatigue.

Detailed Description
-----------------
An equal number of men and women will be recruited [Men, n=20 (10 placebo [PL]; 10 beta-alanine (Active)]; [Women,n=20 (10 PL; 10 Active)]. Men and women will be randomly assigned to respective groups to allow for equal numbers in supplement and placebo groups.

Official Title
-----------------
The Effect of 28 Days of Beta-alanine Supplementation on the Physical Working Capacity at Heart Rate Threshold (PWCHRT)

Conditions
-----------------
Exercise, Fatigue

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: Beta-alanine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18-35 years old Be recreationally active (defined as accumulating 1-5 hours of moderate intensity Exclusion Criteria Any health risks or indicators that would prevent them from participating in physical activity, as determined by a health history questionnaire Must not have taken performance enhancing supplements containing beta-alanine or creatine during the last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>placebo | Dietary Supplement: Placebo<br> <br> |
| Experimental: Beta-Alanine<br>beta-alanine | Dietary Supplement: Beta-alanine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical working capacity at heart rate threshold |  | 0 to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dietary supplement, carnosine
Urinary Retention Rates in Clinical Practice After Treatment With OnabotulinumtoxinA for Idiopathic Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective chart review of patients treated with BOTOX® for idiopathic Overactive Bladder (OAB) as standard of care in clinical practice. The study will determine the rate of post procedural urinary retention requiring catheterization and identify factors that may predict urinary retention.

Conditions
-----------------
Urinary Bladder, Overactive

Intervention / Treatment
-----------------
* Drug: onabotulinumtoxinA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients treated with BOTOX® for Overactive Bladder. Exclusion Criteria: Received botulinum toxin formulations other than BOTOX® in the bladder. Had symptoms of OAB associated with a neurological condition. Had a history of chronic urinary retention treated with Clean Intermittent Catheterization (CIC) or indwelling catheter.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| BOTOX®<br>Patients with idiopathic overactive bladder (OAB) treated with onabotulinumtoxinA (BOTOX®) injections into the bladder as standard of care in clinical practice. No intervention was administered in this study. | Drug: onabotulinumtoxinA<br>* OnabotulinumtoxinA (BOTOX®) as prescribed in clinical practice.<br>* Other names: botulinum toxin Type A;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Post-Procedure Urinary Retention requiring Catheterization |  | 12 Weeks | 
| Length of Time of Clean Intermittent Catheterization (CIC) Use |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Urinary Tract Infection (UTI) |  | 12 Weeks |
Maximizing Language Development in Children With Hearing Loss

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of early intervention on language skills for children with hearing loss.

Official Title
-----------------
Pre-Implantation Communication Treatment for Children With Hearing Loss

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Behavioral: Early language intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6 to 18 months of age bilateral, moderate to profound congenital hearing loss Exclusion Criteria: auditory neuropathy no known additional disabilities (e.g., cerebral palsy, Down syndrome) both parents have a severe to profound hearing loss

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 Months

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early language intervention<br>Children will receive 6 months of weekly parent-implemented intervention sessions. Children will be assessed monthly via audio recordings and language checklists to monitor language development more closely. | Behavioral: Early language intervention<br>* Parents will practice the specific set of strategies (visual, interactive, tactile, responsive) during sessions that occur weekly and last 1 hour for a total of 26 sessions, over 6 months. Each session will include four segments: (a) the therapist will review the intervention strategies taught in the workshop (10 min), (b) the therapist will model the intervention strategy with the child (10 min), (c) the parent will practice the strategy with her child with coaching from the therapist across four different routines and activities of the parent's choice (30 min), and (d) the therapist will provide feedback to the parent, summarize the session, and answer the parent's questions (10 min).<br>|
| No Intervention: Monthly language check-ups<br>Children will be assessed monthly via home observations and parents will complete a language checklist to monitor language development more closely. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MacArthur Communicative Development Inventories |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preschool Language Scale |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hearing Loss, Cochlear Implant, Deaf, Hearing Impairment, Hard of Hearing