linjc16/ctgov huggingface dataset:
Adjustable Strabismus Surgery

Study Overview
=================
Brief Summary
-----------------
Strabismus, whether congenital or acquired, is a common visual and cosmetic problem, especially for the young. Adjustable suture strabismus surgery is not in vogue in our country. This technique gives the surgeon a second attempt to provide a better outcome for the patients.

Official Title
-----------------
Adjustable Strabismus Surgery

Conditions
-----------------
Strabismus

Intervention / Treatment
-----------------
* Procedure: Adjustable strabismus surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Horizontal, vertical and complex strabismus cases (sensory, paralytic, nystagmus, monocular elevation deficit and dissociated vertical/horizontal deviation) were included, along with patients with a previous history of strabismus surgery. Myasthenia gravis was excluded along with noncooperative children; less than 7 years of age. Those who did not return for a one year follow up also had to be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 69 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Adjustable strabismus surgery<br>Our objective was to assess the long-term success of adjustable suture strabismus surgery in terms of postoperative alignment and complications. | Procedure: Adjustable strabismus surgery<br>* Our objective was to assess the long-term success of adjustable suture strabismus surgery in terms of postoperative alignment and complications.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative alignment | The post-operative alignment at 1 year will be measured and compared with the pre-operative alignment (deviation) to assess success rate. | 1 year |
Peripartum Bacteruria and Urinary Tract Infections (UTI)

Study Overview
=================
Brief Summary
-----------------
In the last years urinary tract infections (UTI) and pyelonephritis have been the most common reason for readmission to our hospital after birth. UTI is know to be one of the leading causes of postpartum fever affecting about 3%-8% of all postpartum women. The investigators hypothesize that collecting urine cultures pre- and postnatally may help identify women at risk for developing UTI, while treating women with positive cultures could decrease the rehospitalization rate due to postpartum fever. Collecting data during delivery may help identify women at risk for this complication.

Detailed Description
-----------------
The study is planned as a randomized controlled study with 500 women in each arm. The study group will have pre and post labor urine cultures taken, and the risk factors during delivery will be documented, while the control group will have no cultures taken, as the common practice prior to the study. Women with positive cultures will be contacted by telephone, and antibiotic treatment recommended according to bacteria sensitivity. All women will be contacted by telephone 1 month post partum and data regarding urinary tract symptoms and need for hospitalization, will be collected. The rehospitalization rate will be documented and compared between the two groups. The assumption is that routine urine culture to women in the peripartum period may reduce the UTI rate and hospitalization after delivery.

Official Title
-----------------
Risk Factors for Postpartum Bacteruria, Does Labor Cause UTI?

Conditions
-----------------
Urinary Tract Infection

Intervention / Treatment
-----------------
* Procedure: urine culture
* Drug: antibiotics according to culture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parturients planned for vaginal delivery Exclusion Criteria: Parturients receiving antibiotic treatment during delivery or in the week before
Sexes Eligible for Study
-----------------
Female

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

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 |
| --- |
|Procedure: urine culture|nan|
|Drug: antibiotics according to culture|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of rehospitalization for postpartum fever |  |  | 
| Incidence of UTI in the early puerperium |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postpartum Period
The Adjunctive Use of Lavender and Peppermint Essential Oils

Study Overview
=================
Brief Summary
-----------------
This study will use passive inhalation of lavender for discomfort, anxiety and peppermint for nausea following joint replacement and spine surgery

Detailed Description
-----------------
Following review of records for eligibility and consent obtained during pre op visit subjects will be enrolled in study post op they will validate desire to participate and chose to inhale (2 drops of essential oil on cotton ball in a plastic bag) lavender for discomfort or anxiety or peppermint for GI distress Visual analogue scales will be used to rate discomfort , anxiety and nausea

Official Title
-----------------
The Adjunctive Use of Lavender and Peppermint Essential Oils to Manage Nausea, Pain, and Anxiety in an Adult Orthopedic Population

Conditions
-----------------
Joint Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: Adjunctive use of lavender and peppermint essential oils


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - elective joint replacement able to read and speak English and describe study procedures Exclusion Criteria: pregnancy unable to smell, sensitivity to fragrances asthma or breathing problems have smoke or vaped in last 2 weeks if atrial fibrillation history no peppermint uncontrolled hypertension above 160/100 non employees of UH or students of CWRU

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: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: feasibility of using essential oils post joint replacement surgery and trends toward relief of symptoms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Use of lavender and peppermint essential oils pre and post<br>passive inhalation of either peppermint and lavender essential oil with pre and post test measure | Dietary Supplement: Adjunctive use of lavender and peppermint essential oils<br>* passive inhalation aromatherapy following joint surgery<br>* Other names: aromatherapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| discomfort, anxiety, or GI distress | visual analog sale | total of 90 minutes |
Study Evaluating Bifeprunox in Patients With Schizophrenia.

Study Overview
=================
Brief Summary
-----------------
An open-label extension study using a variable dose (20 to 30 mg daily) of bifeprunox to evaluate long-term safety.

Official Title
-----------------
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Bifeprunox in the Treatment of Outpatients With Schizophrenia.

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Bifeprunox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients who have successfully completed Wyeth study 3168A1-313. A signed and dated informed consent form for this study. No major protocol violations in the previous study. Exclusion Criteria: Clinically important abnormalities in the preceding short-term study that have not resolved. Use of prohibited treatments in the preceding short-term study. Meeting any exclusion criteria in the preceding short-term study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 66 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Bifeprunox<br>* Flex dose (20 or 30 mg)tablet, QD for 1 year<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight from baseline/first dose of bifeprunox at each observation. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline/first dose of bifeprunox in trigyleride levels, Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impressions (CGI) score, and waist circumference at each observation. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia
Enhanced Metal Reduction Techniques for Definitive CT Scanning to Assess Spinal Fusion With TM-Ardis

Study Overview
=================
Brief Summary
-----------------
To determine if the subject metal reduction software helps to better visualize bone interphase and fusion reliability. Assess whether the appropriate procedural modification facilitates clearer images when implanted with a trabecular metal spinal implant

Detailed Description
-----------------
To determine if the subject metal reduction software helps to better visualize bone interphase and fusion reliability, and assess whether the appropriate procedural modification facilitates clearer images when implanted with a trabecular metal spinal implant.

Official Title
-----------------
Evaluating Enhanced Metal Reduction Techniques for Definitive CT Scanning to Assess Spinal Fusion With Trabecular Metal Implants (TM-Ardis)

Conditions
-----------------
Degenerative Disc Disease

Intervention / Treatment
-----------------
* Device: TM- Ardis implant and Metal Reduction CT software


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A signed informed consent. Male or non-pregnant female scheduled for Trabecular Metal (TM - Ardis) implant, single level lumbar. Participant must be at least 18 years of age. Exclusion Criteria: Patient is pregnant Patient is unable to comprehend the requirements of the study. Patient is unable to undergo scanning (due to body habitus, inability to comply with positioning requirements, etc.).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 implanted w/TM-Ardis<br>Patients who are receiving a TM-Ardis implant for degenerative disc disease will have a CT scan immediate post op (2 weeks) and again at 6 months to determine if fusion can be assessed with the study metal reduction software. Will utilize TM- Ardis implant and Metal Reduction CT software | Device: TM- Ardis implant and Metal Reduction CT software<br>* TM- Ardis implant and Metal Reduction CT software<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT scan to determine if the study software can reduce metal scatter on the scan. | Each CT scan will be evaluated to asses if you can visualize fusion, bone interface, and/or device migration with an experimental metal reduction software for CT scan | 6 month post operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trabecular Metal, Metal reduction CT, TM- Ardis
A Phase II Study of Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
This is a phase 2 study to evaluate the efficacy of single-agent icotinib in patients with advanced nasopharyngeal carcinoma.

Detailed Description
-----------------
This phase 2 study is aimed to evaluate the efficacy of single-agent icotinib in patients with pretreated, advanced nasopharyngeal carcinoma. The primary endpoint is disease control rate (DCR).

Official Title
-----------------
Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma: A Phase II, Multi-center, Open-label Study

Conditions
-----------------
Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Drug: Icotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed advanced NPC Patients must be platinum-resistant defined as recurrence or progression of disease <6 months since previous treatment with a platinum based treatment regimen. Measurable disease per RECIST Adequate organ and marrow function Capable of understanding and complying with the protocol, and written informed consent Exclusion Criteria: Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients must not be receiving any other investigational agents Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection Women who are pregnant or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Icotinib<br>Icotinib (125 mg tablet) is orally administered three times daily | Drug: Icotinib<br>* Icotinib (125 mg tablet) is orally administered three times daily until disease progression or unaccepted toxicity.<br>* Other names: Conmana;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate(DCR) |  | At least 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | At least 8 weeks |
Lung Cancer Symptom Assessment and Management Intervention

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop and test the usability of a computerized symptom assessment and management intervention system in a laboratory setting (phase I) and its feasibility in a clinical setting in a group randomized trial (phase II).

Official Title
-----------------
Lung Cancer Symptom Assessment and Management Intervention

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Behavioral: SAMI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCPs: attending physician, thoracic medical oncologist, expected to work in the setting for at least 2 years. Patients: 21 years of age or older; diagnosis of Stage IIIA, IIIB, IV non-small cell lung cancer OR limited or extensive stage small cell lung cancer; receiving care in the out-patient setting; receiving treatment with chemotherapy +/- additional therapies; English speaking. Exclusion Criteria: Patients: Any patient who needs emergent care, routine visits scheduled less than once a month

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAMI<br>Patients and Health care providers use Symptom Assessment and Management Intervention: patient report symptoms by answering validated questionnaires in a secure online program. The system generates a report for providers that displays symptoms and customized suggestions for their clinical management. | Behavioral: SAMI<br>* Patients and Health care providers use Symptom Assessment and Management Intervention: patient report symptoms by answering validated questionnaires in a secure online program. The system generates a report for providers that displays symptoms and customized suggestions for their clinical management.<br>|
| No Intervention: Usual Care<br>Symptom assessment and management follows customary procedures in each study site. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % completion of intervention use and adherence to suggested symptom management strategies. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SAMI, Symptom Assessment and Management Intervention Program
Prone Breast Radiotherapy Treatment Planning Observational Study

Study Overview
=================
Brief Summary
-----------------
The study purpose is to evaluate whether or not clinical characteristics of women with breast cancer can predict which position for radiation treatment, prone or supine, will be associated with a dosimetry gain. Dosimetry gain in this study means the lowest radiation dose to non-target organs (heart, lungs, contralateral breast), while giving the prescribed dose to tumor bed and ipsilateral breast.

Detailed Description
-----------------
Retrospectively identify women who received curative radiation treatment after breast conserving cancer surgery, in whom simulation in prone and in supine position was performed. Compare the treatment plans for doses to targets and to non-target organs, according to clinical parameters of body mass index, size of breast, location of tumor and side. Furthermore, evaluate whether a single CT slide is enough or not to predict a dosimetry advantage.

Official Title
-----------------
Retrospective Dosimetric Study of Prone Radiotherapy for Breast Cancer

Conditions
-----------------
Breast Cancer Female

Intervention / Treatment
-----------------
* Radiation: Prone and supine simulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast conserving surgery Adjuvant radiation treatment Simulation done prone and supine Exclusion Criteria: Simulation in only one position

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prone and supine simulation<br>Women with breast cancer receiving simulation in prone and in supine position for adjuvant radiation treatment. | Radiation: Prone and supine simulation<br>* Treatment planning in the two positions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation dose to heart and lungs | Computations of doses and verification of physics charts. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation dose to tumor bed and ipsilateral breast | Computations of doses and verification of physics charts. | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Breast conserving surgery., Radiotherapy., Treatment planning., Prone.