linjc16/ctgov huggingface dataset:
Myopia Control Spectacle Lens Cessation Study

Study Overview
=================
Brief Summary
-----------------
To quantify myopic progression (cycloplegic spherical equivalent refraction - cSER) following the cessation of use of specific spectacle lenses. To quantify axial length progression following cessation of use of specific spectacle lenses.

Official Title
-----------------
Myopia Control Spectacle Lens Use Cessation Study

Conditions
-----------------
Myopia, Myopia Progression, Juvenile Myopia

Intervention / Treatment
-----------------
* Device: Spectacle Lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously a successfully completed participant in the CYPRESS Extension study; Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day); Willingness to participate in the trial for up to 12 months without contact lens wear; The subject's parent(s) or legal guardian(s) must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form. Exclusion Criteria: Known allergy to proparacaine, tetracaine, or tropicamide.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 16 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test Lens Group<br> | Device: Spectacle Lenses<br>* Standard Spectacle Lenses<br>|
| Active Comparator: Control Lens Group<br> | Device: Spectacle Lenses<br>* Standard Spectacle Lenses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycloplegic Spherical Equivalent Refraction (cSER) | Change in cSER | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycloplegic Spherical Equivalent Refraction (cSER) | Change in cSER | 6 months | 
| Axial Length (AL) | Change in AL | 12 months |
Contribution of the Sonication of Implants to the Diagnosis of Joint Prosthesis Infection: A Retrospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
Studies on sonication suffer from a heterogeneity which makes their analysis complex, due to the absence of a gold standard allowing positive cases to be defined unequivocally. Thus, the sensitivity of the technique has been assessed on cases defined in different ways, which makes the studies difficult to compare (number of samples taken, number of positive samples, variable duration of culture, etc.). It should nevertheless be noted that the majority of the series conclude with a higher sensitivity than that of standard samples, in particular in the event of a strain with difficult growth (Cutibacterium acnes, deficient Streptococci) or in the event of prior antibiotic therapy. In the absence of a comparative reference allowing to conclude on the intrinsic performances of sonication as a diagnostic test, it seems interesting to evaluate its contribution in current practice, in particular in the difficult cases where the standard culture does not make it possible to fulfill the criterion. major (zero or only one positive sample). To the knowledge of the investigators, there is no study of this kind, which could make it possible to specify the place of this technique in the diagnostic procedure and to improve the care of patients.

Official Title
-----------------
Contribution of the Sonication of Implants to the Diagnosis of Joint Prosthesis Infection: Retrospective Cohort Study From 2019 to 2022 at the University Hospitals of Strasbourg

Conditions
-----------------
Prosthesis Related Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patients (age ≥18 years) Have been hospitalized and operated on for a change of hip or knee joint prosthesis between 01/01/2019 and 07/31/2022 Have had at least 3 samples taken for microbiological purposes, pre- or intraoperatively the explanted prosthesis must have been analyzed by sonication. not opposing the reuse of its data for scientific research purposes Exclusion criteria: - Opposition of the patient to the reuse of his data.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with only a peri-prosthetic sample whose culture is positive, and for whom the culture of the sonication fluid is positive and consistent with this first sample, with an objective of >5%. |  | 4 years after implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prosthesis Related Infection, Joint prosthesis infection, Sonication of implants, Cutibacterium acnes, Streptococci
Laparoscopic Natural Gastric Banding for Morbid Obesity

Study Overview
=================
Brief Summary
-----------------
to do gastric banding using round ligament or omental flap instead of synesthetic band

Detailed Description
-----------------
the round ligament or omental flap is used for gastric band instead of synesthetic band which had many complications that led to its abandon

Official Title
-----------------
Laparoscopic Natural Gastric Banding for Management of Morbid Obesity

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Procedure: gastric band


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity patients fit for laparoscopic surgery give approval to share in the study previous restrictive bariatric procedure Exclusion Criteria: patients unfit for surgery patients aged less than 18 and older than 60 patient with previous upper abdominal surgery either for obesity or other diseases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gastric band<br>to do gastric banding use either round ligament or omental flap | Procedure: gastric band<br>* gastric band<br>|
| Active Comparator: sleeve gastrectomy<br>to do sleeve gastrectomy as standard | Procedure: gastric band<br>* gastric band<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %EWL | percentage of excess weight loss at one year | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications rate | the incidence of complications | 12 months |
Oncostatin M in Ulcerative Colitis Patients

Study Overview
=================
Brief Summary
-----------------
Ulcerative colitis (UC) is a refractory disease characterized by symptoms such as diarrhea, bloody stools, and abdominal pain with repeated relapses and remissions.

Detailed Description
-----------------
Evaluation of UC activity is important, and endoscopic evaluations of mucosal inflammation can facilitate subsequent prognostication. On the basis of these considerations, achievement of mucosal healing is important in inflammatory bowel disease (IBD), and evaluation of IBD using endoscopy is extremely important. However, endoscopic examinations are associated with problems such as physical burden to the patient, cost, and risk of complications. Thus, to avoid the need for frequent endoscopy, noninvasive biomarkers that accurately reflect the endoscopic activity of UC have emerged, and fecal calprotectin (FC) and the fecal immunochemical occult blood test (FIT) are being widely used in clinical practice.

Official Title
-----------------
Serum Oncostatin M in Ulcerative Colitis Patients and Its Relation to Severity and Acute Exacerbation

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Diagnostic Test: Oncostatin M


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients aged >18 years and <80 years, of both gender who diagnosed to have UC and given the consent for participation in the study Exclusion Criteria: 1- Any patient with systemic inflammation as Bronchial asthma. 2- History of cancer or tumor. 3- Autoimmune disease such as rheumatoid arthritis and systemic lupus erythematous
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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ulcerative colitis Patients<br>45 Patients with UC. The diagnosis of UC will be based on endoscopic finding and histopathological finding | Diagnostic Test: Oncostatin M<br>* Test to diagnosis of Ulcerative colitis<br>|
| Active Comparator: Control<br>45 apparently healthy subjects as controls who were not UC | Diagnostic Test: Oncostatin M<br>* Test to diagnosis of Ulcerative colitis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify if oncostatin M is a good marker | Diagnosis of Ulcerative colitis and follow up | 6 months |
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study

Study Overview
=================
Brief Summary
-----------------
The preferences of pregnant women for postpartum thromboprophylaxis are largely unknown. The aims of this transversal study are to elicit the preferences of pregnant/postpartum women about postpartum thromboprophylaxis in semi-structured interviews, and to estimate the utility of the relevant health states (pulmonary embolism, deep vein thrombosis, postpartum hemorrhage, subcutaneous injections). In this second aim, the investigators will also compare the effect of 2 different techniques to estimate utilities (standard gamble vs. time trade-off), using a randomization of these techniques.

Official Title
-----------------
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study

Conditions
-----------------
Venous Thromboembolism, Pregnancy Related

Intervention / Treatment
-----------------
* Other: Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women ongoing pregnancy or within 7 days of delivery fluency in French or English Exclusion Criteria: fetal or neonatal death

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant / postpartum women<br>Adult women during pregnancy or the early postpartum period (within 7 days of delivery) | Other: Interview<br>* Structured interview<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference for postpartum thromboprophylaxis | Risk of postpartum venous thromboembolism at which thromboprophylaxis is preferred | 90 days of delivery | 
| Quality-of-life of pulmonary embolism, deep vein thrombosis, postpartum hemorrhage and subcutaneous injections | Measurements of utilities of pulmonary embolism, deep vein thrombosis, postpartum hemorrhage and subcutaneous injections, by standard gamble and time trade-off methods | 90 days of delivery |
Dafilon® Suture Material in Patients Undergoing Ophthalmic Surgery

Study Overview
=================
Brief Summary
-----------------
This is an observational, retrospective postmarket clinical follow-up study and includes all patients who underwent any ophthalmic surgery using Dafilon® suture in the selected centres between 2018 and 2020, therefore no sample size can be given but the planned sample size shall be at least 200 eyes (around 100 patients depending on the number of operated eyes per patient) to conduct meaningful subgroup analysis.

Official Title
-----------------
Observational, Retrospective Clinical Study in Patients Undergoing Ophthalmic Surgery Using Dafilon® Suture Material (Dafilon® USP (United States Pharmacopeia) Sizes From 8/0 to 11/0)

Conditions
-----------------
Eye Diseases

Intervention / Treatment
-----------------
* Device: ophthalmic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient operated between 2018 - 2020 undergoing any ophthalmic surgery using Dafilon® suture material (Dafilon® USP (United States Pharmacopeia) sizes from 8/0 to 11/0) at the participating hospital Exclusion Criteria: No exclusion criteria have been set
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ophthalmic surgery|any ophthalmic surgery using Dafilon® suture|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Suture material complications | Suture material complications needing suture removal or reinterventions (Re-suturing due to wound dehiscence) | up to the retrospective examination (2 to 4 years postoperatively) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Intra-operative complications | Number of Intra-operative complications as documented in the patient's record | intraoperatively | 
| Number of Post-operative complications | Cumulative number of Post-operative complications including Haemorrhage, inflammation and tissue reaction, corneal lesion, retraction, granuloma, and contracture at the postoperative follow-up examination | up to the retrospective examination (2 to 4 years postoperatively) | 
| Incidence of recurrence | Cumulative number of recurrencies | up to the retrospective examination (2 to 4 years postoperatively) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ophthalmologic Surgery
Non-immunogenic Staphylokinase in Reperfusion Therapy of Ischemic Stroke in Routine Clinical Practice

Study Overview
=================
Brief Summary
-----------------
The study will collect data from aged 18 to 85 years with a diagnosis of acute stroke, who received thrombolytic treatment with a new agent, nonimmunogenic staphylokinase. Outcomes will be checked for safety and compared to the results of treatment with the other thrombolytic drug, alteplase.

Official Title
-----------------
Non-interventional Observational Study to Evaluate the Efficacy and Safety of Non-immune Staphylokinase in Reperfusion Therapy of Ischemic Stroke in Routine Clinical Practice

Conditions
-----------------
Acute Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-85 ; Diagnosis of acute ischemic stroke eligible for thrombolytic therapy; Thrombolytic therapy with the drug non-immunogenic staphylokinase is planned or has already been performed. Exclusion Criteria: Individual intolerance or known hypersensitivity to a recombinant protein containing the amino acid sequence of staphylokinase; The presence of a contraindication to thrombolytic therapy of ischemic stroke; Pregnancy or lactation.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of intracerebral hemorrhage | Number and proportion of intracerebral bleeding of any type, which occurs as a complication of thrombolytic treatment | 36 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke thrombolysis, acute ischemic stroke, reperfusion
Post-operative Antibiotics; Effects on Risk of Infection After Cochlear Implant Surgery: A Retrospective Comparison

Study Overview
=================
Brief Summary
-----------------
Currently there is little consensus regarding postoperative antibiotic prophylactic treatment and its effect on the postoperative infection rate after Cochlear implantation. The literature on this subject is contradictory, and very limited. We aim to assess the impact of postoperative antibiotic treatment on post-operative infection rate, and thereby discuss if postoperative antibiotic treatment has any benefits in the preventing treatment against infectious complication.

Official Title
-----------------
Post-operative Antibiotics; Effects on Risk of Infection After Cochlear Implant Surgery: A Retrospective Comparison

Conditions
-----------------
Postoperative Infection

Intervention / Treatment
-----------------
* Drug: Antibiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing cochlear implnations at this facility from 2010 to 2022 Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 120 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 |
| --- | --- |
| Postoperative prophylactics<br>Patients receiving postoperative prophylactic antibiotic treatment | Drug: Antibiotic<br>* Postoperative antibiotic treatment<br>|
| non-postoperative prophylactics<br>Patients NOT receiving postoperative prophylactic antibiotic treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection rate | Number of infected patients | ≥1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection type | Number of patients with minor and major infections | ≥1 year |
Acute Kidney Injury in Cancer Patients Receiving Anti-Vascular Endothelial Growth Factor Monoclonal Antibody vs Immune Checkpoint Inhibitors

Study Overview
=================
Brief Summary
-----------------
The goal of this a retrospective real-world study is to compare the AKI events in cancer patients receiving anti-vascular endothelial growth factor monoclonal antibody (AntiVEGF) vs immune checkpoint inhibitors (ICIs). The main question it aims to answer is whether the choice between AntiVEGF and ICIs affects the risks of acute kidney injury in cancer patients. Cancer patients receiving AntiVEGF will be compared to those treated with ICIs to see if the AKI incidence is higher in patients receiving ICIs.

Official Title
-----------------
Acute Kidney Injury in Cancer Patients Receiving Anti-Vascular Endothelial Growth Factor Monoclonal Antibody vs Immune Checkpoint Inhibitors: a Retrospective Real-world Study

Conditions
-----------------
AKI Incidence of Cancer Patients Receiving AntiVEGF or ICIs

Intervention / Treatment
-----------------
* Drug: AntiVEGF
* Drug: ICIs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >=20yr; Patients must have at least one Evaluation and Managementvisit with a diagnosis of cancer within 12 months before index date (In situ biopsy will not be required, since patients may receive a diagnosis from a biopsy of metastatic site); Indication to initiate AntiVEGF or ICIs Exclusion Criteria: Patients without valid data and less than 3 months followup; Patients without baseline Scr value within 12 mon before index date; Patients with combination therapy of Anti-VEGF and ICIs ; Patients with chronic renal failure

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| AntiVEGF<br>cancer patients receiving anti-vascular endothelial growth factor monoclonal antibody (AntiVEGF) | Drug: AntiVEGF<br>* anti-vascular endothelial growth factor monoclonal antibody drug includes bevacizumab;<br>|
| ICIs<br>cancer patients receiving immune checkpoint inhibitors (ICIs). | Drug: ICIs<br>* immune checkpoint inhibitors include Pembrolizumab, Sintilimab, toripalimab, Camrelizumab, Tislelizumab.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accumulative incidence of sustained AKI | sustained AKI will be defined as the elevation ≥1.5 times baseline sCr for ≥72hours according to the Kidney Disease Improving Global Outcomes (KDIGO) sCr criteria | 12 months after index date |