linjc16/ctgov huggingface dataset:
Complications: Urgent C Section VS Elective C Section

Study Overview
=================
Brief Summary
-----------------
The medical literature does not provide sufficient information or recommendation regarding specific antibiotic coverage for urgent Caesarian sections. The goal of this study is to compare maternal and neonatal morbidity of women who have undergone urgent Caesarian Sections for Prolapsed Cord to those who have undergone Elective Caesarian Sections in order to develop a standard treatment protocol. The Medical Record review will include many parameters including complications, type of antibiotic usage etc.

Official Title
-----------------
Comparison of Maternal and Fetal Complications After Urgent Caesarian Section for Prolapsed Cord Versus Elective Caesarian Section.

Conditions
-----------------
Urgent Caesarian Section Secondary to Cord Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women undergoing urgent Caesarian Section for Prolapsed Cord. women undergoing Elective Caesarian Section. Exclusion Criteria: preterm birth multiple gestation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Urgent Caesarian Section<br> | |
| Elective Caesarian Section<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prophylaxis Antibiotics, Maternal Complications, Neonatal Complications, Cord Prolapse, Elective Caesarian Section, Maternal Morbidity, Neonatal Morbidity
Review of Palliative Radiotherapy in the Management of Advanced Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
To describe the charactersitics of patients with advanced head and neck cancer treated with palliative intent and determine outcome in terms of symptom control and toxicity

Official Title
-----------------
Review of Palliative Radiotherapy in the Management of Advanced Head and Neck Cancer

Conditions
-----------------
Head and Neck Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: squamous cell carcinoma of the head and neck, primary treatment given with palliative intent Exclusion Criteria: radical treatment, palliative treatment following local recurrence, adenocarcinoma, salivary gland carcinoma or melanoma
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
head and neck, cancer, palliation, radiotherapy
A Long-term Follow-up Study to Evaluate the Predictive Value of BMS747158 in Patients Suspected of Coronary Artery Disease (CAD)

Study Overview
=================
Brief Summary
-----------------
This long-term study will follow patients with known or suspected of having coronary artery disease (CAD) and have participated in present and future BMS747158 clinical studies. The purpose of this study is to evaluate the long-term predictive value associated with BMS747158 Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI).

Official Title
-----------------
An Open-Label Prospective, Non-Randomized, International, Multi-center, Long-term Follow-up Study to Evaluate the Predictive Value of BMS747158 Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) in Patients Suspected of Coronary Artery Disease (CAD)

Conditions
-----------------
Coronary Artery Disease (CAD)

Intervention / Treatment
-----------------
* Drug: BMS747158


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have known or suspected CAD Have participated in a BMS747158 clinical study Have received at least 1 dose of BMS747158 Provide signed informed consent for this study prior to any follow-up contact Be capable of communicating effectively with study personnel Exclusion Criteria: If determined by the Investigator that participation in the study is not in the best interest of the patient or for any sound medical, psychiatric, and/or social reason.

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: BMS747158|BMS747158 is a novel PET MPI agent labeled with Fluorine-18.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Independent predictive value of BMS747158 PET MPI | The primary outcome measure is the independent predictive value (PV) of rest and stress BMS747158 PET MPI in defining cardicac populations at high and low risk of developing cardiac events. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of independent incremental PV of BMS747158 PET MPI to SPECT MPI | Comparison of independent incremental PV of BMS747158 PET MPI to that of single photon SPECT MPI in patients with known or suspected CAD | 2 years | 
| Incidence of soft and hard cardiac events post BMS747158 administration | Incidence of soft and hard cardiac events post BMS747158 administration in patients with positive and negative BMS747158 PET MPI scans obtained in the qualifying study | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Disease, PET imaging, SPECT imaging
Helicobacter Pylori Sample Collection Protocol Pre Therapy Subjects

Study Overview
=================
Brief Summary
-----------------
The primary objective is to obtain stool samples from pre-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.

Detailed Description
-----------------
Stools will be collected and tested, at a later date, in a clinical performance study with an investigational H. pylori antigen assay. This study will be coordinated by the Sponsor.

Official Title
-----------------
Helicobacter Pylori Sample Collection Protocol PRE-THERAPY

Conditions
-----------------
Helicobacter Pylori Infection, Gastric Ulcer, Nausea, Abdominal Pain, Weight Loss, Stomach Ulcer, Loss of Appetite, Bloating

Intervention / Treatment
-----------------
* Other: Newly Diagnosed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult ≥ 22 years, either gender Subject is symptomatic showing signs and symptoms of gastritis Subject is not under evaluation for post-therapy follow up diagnosis Subject is already undergoing upper EGD and obtaining a gastric biopsy as part of routine care for H. pylori diagnosing Biopsy is obtained from antrum and/or corpus and is tested by CRM At least two of the three CRM tests are performed Subject whose EGD with biopsy procedure occurred ≤ 7 days prior to stool collection Willing and able to sign the IRB approved Informed Consent form for this project, or able to provide Informed Consent in accordance with 21 CFR 50 Subpart B Exclusion Criteria: Any subject that does not meet the inclusion criteria Subject with current severe H. pylori infection Subject ingested compounds that may interfere with detection of H. pylori e.g. 4 weeks for all antibiotics, 2 weeks for Bismuth preparations or proton pump inhibitors prior to EGD/collection Subject recently tested, less than 3 months and knowledge of H. pylori absence Subject tested, less than one year and knowledge of H. pylori presence but NOT undergone prescribed treatment Pregnant or lactating Inability or unwilling to perform required study procedures Subject is unable or unwilling to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Newly Diagnosed|Gastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori Stool Collection | In vitro diagnostic (IVD) device performance | Through Study Completion, an average of 1 year |
Excimer Lamp Versus Excimer Laser in Vitiligo Treatment

Study Overview
=================
Brief Summary
-----------------
308 nm excimer lamp and 308 nm excimer laser have both provide interesting results in treating vitiligo. They have the same wavelength but the type of emission of the photons is different. To date there is no direct comparative data concerning these two devices in this indication. The aim of the study is to make an intra-individual prospective comparison between these two phototherapies.

Official Title
-----------------
Comparative Study of 308nm Excimer Lamp and 308nm Excimer Laser in the Treatment of Vitiligo

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Radiation: 308nm excimer lamp
* Radiation: 308nm excimer laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient above 18 vitiligo for more than 3 months at least 2 vitiligo symmetric patches more than 10cm² to read and understand the inform consent to have a social security number non pregnant for women Exclusion Criteria: pregnant women keloids history of radiotherapy or skin cancer in the treated areas treatment for vitiligo in the past 4 weeks phototherapy in the past 12 weeks; history of photodermatosis treatment inducing photosensibilization immunosuppression patient who participated in a study in the past 3 months

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 |
| --- | --- |
| Active Comparator: A<br>308 nm excimer lamp | Radiation: 308nm excimer lamp<br>* 50 mJ/cm² below the MED (minimal erythemal dose) and progressive increase Twice a week for 12 weeks<br>|
| Active Comparator: B<br>308 nm excimer laser | Radiation: 308nm excimer laser<br>* 50 mJ/cm² below the MED (minimal erythemal dose) and progressive increase Twice a week for 12 weeks (same doses will be used between the 2 arms)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repigmentation rate in the treated areas |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance and safety of the treatments |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitiligo
Postmarketing Surveillance Study of Berotec® N 100 µg Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease

Study Overview
=================
Brief Summary
-----------------
Study to obtain data about changing from the chlorofluorocarbon (CFC) - containing Berotec® 200 µg metered - dose inhaler to the CFC - free Berotec® N 100 µg metered - dose inhaler

Official Title
-----------------
Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berotec® N 100 µg Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Berotec® N 100 µg Metered-dose Inhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were included in the study only if they had been treated with Berotec® 200 µg metered - dose inhaler before switching to the CFC-free Berotec® N 100 µg metered - dose inhaler Exclusion Criteria: • Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berotec® N 100 µg metered - dose inhaler
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Obstructive Respiratory Tract Disease<br> | Drug: Berotec® N 100 µg Metered-dose Inhaler<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the clinical picture of chronic obstructive airways disease on switching from Berotec® 200 µg to Berotec® N 100 µg |  | After 3 weeks of first drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator assessment of efficacy on a 4-point scale |  | Up to 3 weeks after first drug administration | 
| Patient assessment of efficacy on a 4-point scale |  | Up to 3 weeks after first drug administration | 
| Patient assessment of tolerability on a 4-point scale |  | Up to 3 weeks after first drug administration | 
| Investigator comparative overall assessment on a 4-point scale |  | After 3 weeks of first drug administration | 
| Number of patients with adverse drug reactions |  | Up to 3 weeks after first drug administration | 
| Number of patients who changed the concomitant medication |  | Up to 3 weeks after first drug administration | 
| Number of patients who continued treatment |  | Up to 3 weeks after first drug administration | 
| Number of patients who premature withdrew from the treatment |  | Up to 3 weeks after first drug administration |
Long-Term Follow-Up Study of Patients With Osteoarthritis of the Knee Treated With UBX0101 or Placebo

Study Overview
=================
Brief Summary
-----------------
A follow-up study to assess the long-term safety of intra-articular (IA) administration of UBX0101 in patients with painful knee osteoarthritis (OA).

Detailed Description
-----------------
This is a blinded, multi-center study to provide approximately 1 additional year of follow-up for patients with knee OA who participated in a randomized placebo-controlled study of IA UBX0101. No intervention is planned and patients will have 4 scheduled visits to collect follow-up assessments. The primary objective is to evaluate long-term safety and tolerability of IA administration of UBX0101 in patients with painful knee OA.

Official Title
-----------------
Long-Term Follow-Up Study of Patients With Moderate to Severe, Painful Osteoarthritis of the Knee Who Participated in a Randomized, Placebo-Controlled Study of UBX0101

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Drug: UBX0101 or placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with knee OA who have completed a randomized placebo-controlled study of UBX0101. Patients who are willing and able to consent to having blinded, long-term follow-up; consent via legally authorized representative is not accepted. Exclusion Criteria: Patients with any condition that, in the opinion of the Investigator, would likely interfere with adhering to the study schedule of visits for 12 months. Patients who are scheduled to undergo knee arthroplasty on either knee during the study. Patients who anticipate arthroscopic surgery on either knee at any time during the study. Patients who plan to receive treatment with an anti-nerve growth factor agent during the study. Patients who plan to participate in another investigational study (including interventional studies of investigational drugs and investigational treatments [e.g., braces, stem cells, and procedures]) during the study.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 from a randomized placebo-controlled study of UBX0101<br>Patients with moderate to severe, painful OA of the knee who participated in a randomized, placebo-controlled study of UBX0101. | Drug: UBX0101 or placebo<br>* This is an observational study. No intervention is administered.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events up to 1 additional year of follow up. |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Painful Osteoarthritis, Osteoarthritis, Knee, Senescence
Dynamic Change in Accommodation After Wearing Multifocal Soft Contact Lenses for Myopia Control

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to report the changes in accommodation, aberrations, and myopia in patients wearing multifocal soft contact lens for various durations. The study objectives are to: Determine the effects of wearing multifocal soft contact lens on accommodation and aberrations over a 12-month period. Determine the effect of wearing multifocal soft contact lens on myopia over a 12-month period.

Official Title
-----------------
Dynamic Change in Accommodation After Wearing Multifocal Soft Contact Lenses for Myopia Control

Conditions
-----------------
Accommodation, Myopia

Intervention / Treatment
-----------------
* Device: Multifocal soft contact lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 8-17 years Refractive error: Sphere ≤ -10.00D, Cylinder ≤ 1.00D Monocular BCVA 20/25 or better No previous CL experience required Exclusion Criteria: History of ocular pathology, binocular vision anomalies, refractive surgery, previous myopia control therapy, pharmaceutical agent known to affect accommodation.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 17 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Subjects wore multifocal soft contact lenses for 12 months. | Device: Multifocal soft contact lenses<br>* Myopic subjects wore multifocal soft contact lenses for 12 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length | Change in axial length over the duration of the study | 12 months | 
| Refractive error | Change in refractive error over the duration of the study | 12 months | 
| Accommodation | Accommodation at various distances during the study | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phoria | The amount of horizontal phoria (in prism diopter) at near while the subjects wore multifocal soft contact lenses, measured using Modified Thorington | 12 months |
Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
The primary objective is to determine the maximum tolerated dose of AVE9633 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-leukemia activity, the global safety and the PK profile.

Official Title
-----------------
An Open Label, Dose-Escalation Safety and Pharmacokinetic Study of AVE9633 Administered as a Single Agent by Intravenous Infusion on Day 1, Day 4 and Day 7 of a 4-Week Cycle in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML)

Conditions
-----------------
Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: AVE9633


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with CD33-positive acute myeloid leukemia, refractory or relapsed after standard treatment with no curative option available ECOG performance status 0 to 2 Exclusion Criteria: Therapy with gemtuzumab ozogamicin (Mylotarg) within 6 months prior to inclusion Allogenic transplantation within 6 months prior to inclusion Prior therapy (chemotherapy, targeted agents, radiotherapy) within 3 weeks except for hydroxyurea and for leukophoresis Previous treatment with AVE9633 Poor kidney, liver and bone marrow functions Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study Pregnant or breast-feeding women Patient with reproductive potential without effective birth control methods The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AVE9633|Intravenous Infusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Dose Limiting Toxicity(ies) at each tested dose level |  | Study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Remission (CR) / Remission with incomplete platelet recovery (CRp), Partial Remission (PR) rate, time to CR and duration of CR, peripheral blast clearance |  | Study period | 
| Incidence of Adverse Events |  | Study period |