linjc16/ctgov huggingface dataset:
Perioperative Aspirin Usage Survey

Study Overview
=================
Brief Summary
-----------------
This is a survey of members of the American College of Surgeons (ACS), to describe and explore current patterns of their decisions about withholding or continuation for patients taking aspirin (ASA) in the perioperative period. Secondarily, the survey will also explore surgeons' knowledge about the risks and benefits attending this decision, and about national organizations' recommendations.

Detailed Description
-----------------
An announcement of the survey and invitation to participate will be posted in the ACS Surgery News newsletter published by the American College of Surgeons. Surgeons of all specialties will be invited to participate. No identifiers will be maintained with survey responses. In addition to the substantive questions below, typical demographic data will be obtained including participants' duration of practice, specialty, gender, state, etc. The survey will include questions intended to characterize current practice surrounding the decision to continue or withhold aspirin in the perioperative period. Other questions will focus on surgeons' knowledge of national medical/surgical organizations that have published guidelines on the perioperative use of aspirin. Finally, other survey questions will characterize surgeons' knowledge of the platelet rebound effect.

Official Title
-----------------
Use of Aspirin in the Perioperative Setting: A Surgeon's Survey

Conditions
-----------------
Surgery, Cardiovascular Disease

Intervention / Treatment
-----------------
* Behavioral: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Members of the American College of Surgeons Exclusion Criteria: None

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 |
| --- | --- |
| American College of Surgeons members<br>Survey participants | Behavioral: Survey<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Typical proportion of participants' patients given a recommendation to stop taking aspirin |  | At time of survey; generally less than 20 minutes | 
| Proportion of participants correctly identifying national organizations with perioperative aspirin recommendations |  | At time of survey; generally less than 20 minutes | 
| Proportion of participants correctly answering questions about platelet rebound effect |  | At time of survey; generally less than 20 minutes |
The Pooling Expressed Breast Milk: A Method for Improving the Nutritional Intake of Premature Infants

Study Overview
=================
Brief Summary
-----------------
The investigators compared a pooled mother's expressed breastmilk for 24 hours with individual pump session collection of milk to provide a more consistent caloric product without increasing bacterial contamination.

Conditions
-----------------
Breastfeeding Mothers of Infants Hospitalized

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mother of newborn hospitalized in intensive care unit Mother using a breast pump in the unit and / or at home Mother respected the rules of handling and transport breastmilk No opposition mother Exclusion Criteria: refusal
Sexes Eligible for Study
-----------------
Female

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| caloric value of breastmilk | The caloric value will be compared between the two groups (pooled expressed breastmilk versus individual expressed breastmilk) | at the end of each 24 hours collection from inclusion to the end of collection during 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bacterial contamination of breastmilk | The bacterial contamination of breastmilk will be compared between the two groups with the value for colony-forming units per milliliter (cfu/mL) after plating on sheep blood agar and Chapman's agar. | at the end of each 24 hours collection from inclusion to the end of collection during 4 days |
Open Label Extension of LipoLat-CS202

Study Overview
=================
Brief Summary
-----------------
This is an open-label, observational extension of patients who received POLAT-001 in LipoLat-CS202.

Official Title
-----------------
An Open-label Extension Study of the Safety and Efficacy of Subconjunctival Liposomal Latanoprost (POLAT-001) in Patients With Ocular Hypertension and Primary Open Angle Glaucoma

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Other: Observation only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Successful completion of 3 months of participation in Study LipoLat-CS202. Treatment with POLAT-001 in Study LipoLat-CS202. Able and willing to give signed informed consent and follow study instructions. Exclusion criteria Excluded from the study will be individuals with the following characteristics: 1. The development, during study LipoLat-CS202, of any exclusion criteria from that study (e.g., concomitant medication or co-morbid disease).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observation only|No intervention in this study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) | Mean change from baseline (Visit 1 in Study LipoLat-CS202, NCT02466399) IOP at Month 3 (6 months after treatment in LipoLat-CS202). | 3 months |
Prediction of Perineal Tears by Striae Gravidarum Score

Study Overview
=================
Brief Summary
-----------------
Previous studies concluded that striae gravidarum assessment appears to predict the occurrence of perineal tears and recommend training the health personnel to calculate the total striae score which can help them decide if episiotomy is to be given or not. Episiotomy definitely seems to be preventive for perineal tears but giving episiotomy for the same is still debatable as episiotomy in itself is associated with morbidity. the hypothesis is episiotomy done in patients with high score will definitely protects against perineal tears. So, the aim of study is to determine whether assessment of striae gravidarum score could predict occurrence of tears during labor or not, and if episiotomy will prevent perineal tears in women with high score.

Official Title
-----------------
Episiotomy for Prevention of Perineal Tears During Labor in Women With High Striae Gravidarum Score

Conditions
-----------------
Normal Labor

Intervention / Treatment
-----------------
* Procedure: Episiotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Multipara Singleton pregnancy Full-term (37- 40 weeks) Average size fetus (2500-4000 gm) Cephalic-vertex presentation Spontaneous onset of labor No scarred uterus No medical diseases as hypertension No obstetric complications as obstructed labor Women accepted to participate in the study Exclusion criteria: Multiple pregnancy Women with Previous cesarean sections Preterm labor Malpresentation Fetal macrosomia Medical diseases as diabetes and hypertension Women refuse to participate in the study
Sexes Eligible for Study
-----------------
Female

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Episiotomy | Procedure: Episiotomy<br>* episiotomy will be done after crowning of the fetal head<br>|
| No Intervention: Group B<br>no episiotomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of third and forth degree perineal tears |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of first and second degree perineal tears |  | intraoperative |
Various Type of Genetic Events in Patients With Intellectual Disability

Study Overview
=================
Brief Summary
-----------------
Currently, for a patient with intellectual disability without a recognizable syndrome (most cases), the way to diagnosis is often long, tedious and expensive because different approaches are used one after the other to identify structural variants (duplications, deletions and other) and point mutations (sequencing of one or more candidate genes). The development of high-throughput sequencing techniques (next generation sequencing: NGS) has drastically increased the detection of point mutations offering the possibility to test a large number of genes simultaneously. NGS also shows a huge potential in detecting structural variants. The objective of this research is to assess the sensitivity of a simultaneous detection of point mutations and structural variants by NGS approaches. This would bring together in a single step the equivalent of performing an array-Comparative genomic hybridization (CGH) analysis plus performing a targeted sequencing of candidate genes. Investigators will compare two approaches for this simultaneous detection: a targeted enrichment of candidate genes coding regions using probes covering these regions associated with a backbone of genomic probes, an approach that could be implemented immediately in diagnostic at the hospital, and a whole genome sequencing (WGS), that is currently a too expensive tool for routine diagnosis but that should be the approach used in the future. Investigators will compare these two approaches to the traditional one: CGH array + WGS. The implementation of a one step strategy to detect both types of mutations (punctual and structural) would accelerate and improve the access of patients to a molecular diagnosis.

Official Title
-----------------
Evaluation of Tools for the Simultaneous Detection of Point and Structural Mutations in Patients With Intellectual Disability

Conditions
-----------------
Intellectual Disability

Intervention / Treatment
-----------------
* Genetic: Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with developmental disabilities No etiologic diagnosis but suspected genetic cause Fragile X syndrome research negative Exclusion Criteria: Children born to consanguineous couples Diagnosis already established or suspected Identification of an independent etiology

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Blood samples|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of mutation from the CGH-array technology on 475 genes |  | One year |
Metabolomic and Proteomic Fingerprinting in Peri-implant Diseases

Study Overview
=================
Brief Summary
-----------------
Due to the limited efficacy of its treatment modalities, there is a stringent need to improve the prevention and early diagnosis of peri-implantitis. In fact, to date clinical and radiographic tools are not able to discern which patients are going to develop peri-implantitis and, among the ones already with peri-implantitis, which ones are currently loosing bone and which ones are going to progress. This project aims to analyze for the first time the whole large scale proteome and metabolome of peri-implant crevicular fluid (PICF) with an integrated approach from implants with peri-implant diseases. Twenty-five patients with at least one implant with peri-implant mucositis and one implant with peri-implantitis will be selected. For each of the selected participants, the PICF from an implant with peri-implant mucositis and from an implant with peri-implantitis will be sampled two different times before treatment. One year after the corresponding treatment is provided, the PICF of the treated implants with peri-implantitis will be sampled again. Both proteomic and metabolomic profiling of the samples will be carried out. The most important strength of this project will be the ability to evaluate together the whole proteome and the whole metabolome and to integrate them in the same framework.

Official Title
-----------------
Metabolomic and Proteomic Fingerprinting in Peri-implant Diseases

Conditions
-----------------
Peri-implant Mucositis, Peri-Implantitis

Intervention / Treatment
-----------------
* Diagnostic Test: PICF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one implant with peri-implant mucositis and one with peri-implantitis Exclusion Criteria: Previously treated implants to be included
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: PICF|PICF collection from 4 sites|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-implant diseases presence | Presence or absence of peri-implant mucositis or peri-implantitis according to the 2017 World Workshop (Berglundh et al. 2018) | Baseline (cross-sectional part) | 
| Disease resolution of peri-implantitis | According to the criteria proposed by Sanz & Chapple (2012) | 1-year after treatment (longitudinal part) |
Handwriting Rehabilitation in Parkinson Disease

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the efficacy of an intensive handwriting treatment in Parkinson's Disease.

Detailed Description
-----------------
The investigators aimed to understand whether an intensive handwriting treatment with cognitive engagement is more effective than a treatment exploiting only the passive wrist joint mobilization in Parkinson's Disease.

Official Title
-----------------
Effectiveness of Intensive Handwriting Rehabilitation in Subjects With Parkinson's Disease

Conditions
-----------------
Parkinson Disease, Neurorehabilitation, Handwriting

Intervention / Treatment
-----------------
* Behavioral: Writing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's Disease patients Exclusion Criteria: Mini Mental State Examination (MMSE) score < 24 Left handed subjects Subjects with dyskinesias Subjects with Deep Brain Stimulation

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - Writing with 1 cm cue<br>This group uses to write space of 1 cm size | Behavioral: Writing<br>* Writing exercise with or without cues for 1 hour per day for 4 days at week for 4 weeks<br>|
| Experimental: Group 2 - Writing with 1.5 cm cue<br>This group uses to write space of 1.5 cm size | Behavioral: Writing<br>* Writing exercise with or without cues for 1 hour per day for 4 days at week for 4 weeks<br>|
| Experimental: Group 3 - Writing without cue<br>This group writes without using cues | Behavioral: Writing<br>* Writing exercise with or without cues for 1 hour per day for 4 days at week for 4 weeks<br>|
| No Intervention: Group 4 - no writing<br>This group do not write. Only wrist mobilization is performed. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| letters size |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| writing speed (time spent to write every single letter and word, measured in milliseconds) |  | 4 weeks | 
| centimeters away from a straight line during writing |  | 4 weeks |
A Clinical Investigation of the C2a-Taper™ Acetabular System

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to gather clinical and survivorship information for the C2a-Taper™ Acetabular System, a ceramic-on-ceramic hip articulating system.

Detailed Description
-----------------
Study Design: Phase 1 Sites will collect the following types of data: Clinical-Total Harris Hip Score, Radiographic Evaluation- measurements on acetabular and femoral components Survivorship-removal/revision of one or more components (i.e. liner, head, shell and/or stem) Safety- All other adverse events Follow-up Visit schedule 6 week ± 2 weeks 6 month ± 1 month 1 year ± 3 months 2 years ± 3 months 3 years ± 3 months 4 years ± 3 months 5 years ± 3 months Phase 2: Patients continue to be followed on an annual basis (Years 6-10) via mail. A self assessment form is sent directly to the subject on an annual basis starting in the 6th post-operative year.

Official Title
-----------------
Post Approval Study of the C2a-Taper™ Acetabular System

Conditions
-----------------
Osteoarthritis, Avascular Necrosis, Congenital Hip Dysplasia, Traumatic Arthritis

Intervention / Treatment
-----------------
* Device: C2a - Taper™ Acetabular System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis Exclusion Criteria: Patients with: Osteoporosis, metabolic disorders, osteomalacia, rapid joint destruction, vascular insufficiency, muscular atrophy, and neuromuscular disease

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 |
| --- | --- |
| C2a Taper recipients<br>Patients who receive a THA with the C2a - Taper™ Acetabular System | Device: C2a - Taper™ Acetabular System<br>* The C2a-Taper™ Acetabular System is a ceramic on ceramic hip articulating system. The bearing surfaces consist of ceramic femoral heads and acetabular liners.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score, Radiographic Evaluation |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip Arthroplasty, Hip Arthritis
Effect of Detrol LA on Overactive Bladder Symptoms, Sexual Quality of Life and Sexual Function in Women

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the impact of treatment with tolterodine ER versus placebo on Urgency Urinary Incontinence in sexually active women with OAB symptoms.

Official Title
-----------------
A Multi-Center, Double-Phase, Randomized, Double-Blind, Placebo Controlled (12-Week Double-Blind Followed by 12-Week Open-Label) Study Evaluating the Effect of Tolterodine ER on Urgency Urinary Incontinence (UUI), Urgency, Frequency, Sexual Quality of Life and Sexual Function in Women With Overactive Bladder

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Drug: Tolterodine ER 4mg QD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female outpatients 18 years or older. Overactive bladder symptoms (subject-reported) for greater than or equal to 3 months. Currently sexually active with a male partner. Exclusion Criteria: Diagnosed or suspected interstitial cystitis, uninvestigated hematuria, urogenital cancer, and interstitial or external radiation to the pelvis or external genitalia or clinically significant bladder outlet obstruction. Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator. Treated with antimuscarinic/ anticholinergic medication, for any reason including OAB, within the last 3 months or are expected to start therapy during the study treatment period. Any drug for urgency urinary incontinence (UUI) initiated within the past 3 months prior to Visit 1, with the exception of estrogen (topical or systemic) as long as treatment is not initiated within 4 weeks prior to Visit 1 (screening)

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

Sexes Eligible for Study
-----------------
Female

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: Tolterodine ER 4mg QD|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total number of urgency urinary incontinence (UUI) episodes at weeks 4 and 24 compared with baseline |  |  | 
| Change in total number of daytime urgency urinary incontinence (UUI) episodes at week 4, week 12, and week 24 compared with baseline |  |  | 
| Change in total number of pads used per 24 hours at weeks 4, 12, and 24 compared with baseline |  |  | 
| Reasons for treatment withdrawal |  |  | 
| Adverse Events during the 24 week treatment period. |  |  |