linjc16/ctgov huggingface dataset:
Characterizing and Comparing the Profile of Microorganisms From Specific Body Sites and Environmental Surfaces in Newly Disinfected Patient Rooms

Study Overview
=================
Brief Summary
-----------------
Overall Aim: To describe and to assess the change in the temporal profile and transmission of microorganisms between patients and environmental surfaces after admission into a newly disinfected room. Study Activities: Investigators will prospectively and concurrently perform microbiological sampling of body sites (nose, throat, axillae, perineal and wounds) high touch surfaces (e.g. bedside rail, bed surface, toilet seat, IV pump and tray table) for consented adult patients admitted to freshly cleaned patient rooms. The microbiological sampling of body sites is already performed in many units of the hospital as standard of care. Infection and readmission related data from enrolled patients will be collected for upto 1 year after enrollment. Data analysis: Standard surveillance for hospital-acquired infections will be performed by the infection control group of the hospital. The identity and the nature of micro-organisms colonizing the high touch surfaces of rooms and of patient's body sites will be determined and compared. Risks involved is no more than minimal risk.

Official Title
-----------------
Study of the Temporal Profile and Bi-directional Transmission of Microorganisms Between Patients and Environmental Surfaces.

Conditions
-----------------
Bacterial Infection

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients who provide informed consent. Exclusion Criteria: Pediatric patients under 18 years of age, Patients who cannot or do not provide consent

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 |
| --- | --- |
| Hospitalized inpatients<br>Inpatients newly admitted into freshly-cleaned rooms. | Other: No intervention<br>* There is no intervention in this trial<br>* Other names: There is no intervention in this trial;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Profile of Epidemiologically-Important Organism |  | Day 3, 7 and each week after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Change in the Profile of Epidemiologically Important Organism |  | Day 3, 7 and each week after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bacterial Colonization
Observational Study to Evaluate the Safety and Efficacy of NovoMix® 70 in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 70 under normal clinical practice conditions in Austria.

Official Title
-----------------
Observational Study on Safety and Efficacy in Subjects Using NovoMix® 70 (Biphasic Insulin Aspart) for Treatment of Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes HbA1c over 7% No contraindication with NovoMix® 70 Exclusion Criteria: Type 1 diabetes Subjects participating in a clinical trial or another observational study Subjects under previous basis-bolus insulin therapy Women who are pregnant, breast feeding and women of child bearing capacity who are not using any reliable contraceptive method

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 |
| --- | --- |
| A<br> | Drug: biphasic insulin aspart<br>* Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation<br>* Other names: NovoMix® 70;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of major and minor hypoglycaemic events and adverse events |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 3 months | 
| PPBG |  | 3 months | 
| FBG |  | 3 months |
Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children

Study Overview
=================
Brief Summary
-----------------
The investigators created a randomized clinical trial between 1 or 2 elastic stable intramedullary nails to find out what kind of treatment is optimal for unstable both-bone midshaft forearm fractures.

Detailed Description
-----------------
Children who arrive at the emergency unit with an unstable both-bone midshaft forearm fracture will be asked to join the trial. If the fracture will be unstable during reposition in the operating room, a randomization between 1 or 2 ESIN will be done. The aftertreatment will be the same for both groups: above elbow plaster for 3 weeks. Outpatient clinic visits till a follow-up of 9 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complaints in daily living and complications.

Official Title
-----------------
Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children: A Randomized Trial Between 1 and 2 Elastic Stable Intramedullary Nails

Conditions
-----------------
Fracture

Intervention / Treatment
-----------------
* Procedure: 1 or 2 elastic stable intramedullary nails


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable both-bone forearm fracture Age < 16 years old Dislocation Unstable Exclusion Criteria: Fracture older than 1 week No informed consent Refracture Open fracture (Gustillo 2 and 3)

Ages Eligible for Study
-----------------
Maximum Age: 15 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 1 or 2 elastic stable intramedullary nails|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pronation and supination |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications, function, esthetics, complaints in daily living, X-rays |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fracture, forearm, midshaft, child, treatment
Efficacy of Sildenafil in Preterm Preeclampsia

Study Overview
=================
Brief Summary
-----------------
Randomized controlled trial to assess efficacy of Sildenafil in addition to expectant management for the treatment of preterm preeclampsia

Detailed Description
-----------------
Preeclampsia is a major cause of maternal mortality. When preeclampsia presents prior to thirty-four weeks of gestation, expectant management is the standard practice in stable patients with the goal of extending pregnancy and therefore decreasing the risk of adverse outcomes in the premature neonate. Our aim was to assess the efficacy of Sildenafil, a phosphodiesterase inhibitor, versus placebo, in addition to expectant management, for the treatment of preterm preeclampsia to prolong pregnancy.

Official Title
-----------------
Randomized Double-Blind, Placebo Controlled Evaluation of the Efficacy of Sildenafil Versus Placebo in Preterm Preeclampsia

Conditions
-----------------
Preterm Preeclampsia

Intervention / Treatment
-----------------
* Drug: Sildenafil
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients of gestational age of ≥24 0/7 weeks to ≤32 0/7 weeks. Dating of pregnancy by ultrasound < or equal to 22 weeks or IVF conception Diagnosis of Preterm Preeclampsia or Superimposed Preeclampsia Exclusion Criteria: Need for immediate delivery of the fetus Known lethal anomaly Pre-existing renal disease Hypersensitivity to sildenafil Pre-gestational diabetes, class C (onset prior to 10-19 or duration 10-19 yrs Active peptic ulcer disease Undergoing nitrate therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sildenafil<br>Sildenafil 40mg oral tablet three times a day from randomization until delivery | Drug: Sildenafil<br> <br> |
| Placebo Comparator: Placebo<br>Matched to oral capsule of active treatment three times a day from randomization until delivery | Drug: Sildenafil<br> <br> Drug: Placebo<br>* Color and size matched to active drug (sildenafil)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency (duration of pregnancy from diagnosis/randomization until delivery) | earliest randomization can occur at 24 weeks gestation | Diagnosis (randomization) until delivery, up to 34 weeks) |
Cerebellum - Cognitive Outcome and Functional Connectivity

Study Overview
=================
Brief Summary
-----------------
Aim: To investigate the effect of cerebellar tumor surgery on the resting state functional connectivity level in higher order cognition networks known to interact with the cerebellum. Furthermore, to correlate the connectivity level of these networks with the neuropsychological performance and functional outcome of the patients. The investigator's hypothesis is that the functional connectivity of various cognition networks in the cerebrum as assessed by resting-state functional magnetic resonance imaging can be impaired after cerebellar tumor surgery and can be correlated with the neuropsychological performance. The effect of surgery on the cognition networks and the neuropsychological performance is dependent on the tumor location within the cerebellum. Such a correlation seems feasible as functional connectivity analysis could be correlated with the neuropsychological impairment in various neuropsychiatric disorders. Furthermore, investigators were able to depict the maturation of the functional connectivity networks in parallel to the neurocognitive development in childhood

Official Title
-----------------
Cerebellar Tumors of Childhood - Impact on Cognition and Functional Connectivity

Conditions
-----------------
Childhood Cerebellar Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Male or female patients aged > 15 yrs Age at surgery between 1 yrs - 12 yrs Compliance (the patients have to be able to lay motionless in a 3 Tesla MR scanner and to cooperate with the examiner during the examination) Signed informed consent from the patient and/or the parents Exclusion Criteria: • Patients with Neurofibromatosis 1 Severe visual or auditory impairment Cerebrospinal fluid shunt device Prior radiotherapy or chemotherapy Contraindications to MRI

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 30 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 |
| --- | --- |
| patients<br>children operated on a cerebellar tumor | |
| healthy subjects<br>healthy volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuropsychological assessment |  | up to 24 months |
Factors Associated With CPC 1-2 in 110 Patients Admitted in French ICU for a Myocardial Infarction Complicated by an OHCA.

Study Overview
=================
Brief Summary
-----------------
This study evaluate the association of some in-ICU factors with the neurological prognosis of patients admitted for an out-of-hospital cardiac arrest due to a myocardial infarction.

Detailed Description
-----------------
Pre-hospital factors associated with poor neurologic outcome are well known. Meanwhile, in-ICU factors for the first 24 hours may impact neurologic outcome. This observational study aim to study the factors such as ECLS, NSE dosage, therapeutic hypotermia... and their association with neurologic outcome in patient with myocardial infarction due to instable coronaropathy complicated by an out-of-+hospital cardiac arrest. This is designed to be a observationnal, prospective, multicentric national french study

Official Title
-----------------
Factors Associated With Neurological Prognosis 30 Days After an ICU Admission for a Myocardial Infarction Complicated by an Out-of-Hospital Cardiac Arrest : an Observationnal Multicentric Study

Conditions
-----------------
Out-Of-Hospital Cardiac Arrest, Myocardial Infarction, Coma, Outcome, Fatal, Neurologic Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged of 18 years old or more non opposition of the patient, or his family if he is unable to consent, after loyal and comprehensive explanation patient admitted in ICU the reason for admission is a resurected out-of-hospital cardiac arrest the cause of the cardiac arrest is a type 1 myocardial infarction Exclusion Criteria: refractory cardiac arrest (no flow > 30 minutes in normothermia) in-hospital cardiac arrest pregnancy patient under juridic protection opposition of the patient, or of his family is he is unable to consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Neurologic outcome (CPC) | Cerebral Performance Category Scale to assess neurologic outcome 1-2 : good outcome 3-4-5 : bad outcome | 30 day from in-ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurologic outcome (Rankin) | Rankin score to assess neurologic outcome 0-1-2 good outcome 3-4-5 bad outcome | 30 day from in-ICU admission | 
| death | all-causes death | 30 day form in-ICU admission |
Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Determine the characteristics of symptoms and functional impairment associated with chemotherapy induced peripheral neuropathy.

Detailed Description
-----------------
Taxanes, a type of chemotherapeutic agent prescribed to breast cancer patients, have a known physical side effect of chemotherapy induced peripheral neuropathy (CIPN). The purpose of this qualitative study is to understand the experience and physical functional side effects of taxanes. This is the first of a two phase study. The overall goal is to identify existing objective physical performance measures to assess functional side effects of taxanes.

Official Title
-----------------
Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 21-70 years old (Women over 70 are offered chemotherapy less frequently because of their risk benefit ratio. Including them would be a selection bias because of their differential underexposure). Initiated taxane-based chemotherapy in the neoadjuvant, adjuvant, or previously untreated metastatic setting. The range of exposure to taxane-based chemotherapy will include women on active treatment having received two cycles, to women who are within three months of their last infusion. Documented symptoms of CIPN per CTCAE grading criteria (half of sample) or NO symptoms (half of sample) Grade 0 = no CIPN symptoms Grade 1 = mild symptoms Grade 2 = moderate symptoms - prescribed Gabapentin (Neurontin) Grade 3&4= severe symptoms - treated with Gabapentin (Neurontin), treatment plan altered Exclusion Criteria: Physical disabilities - defined by use of assistive devices to complete functional tasks (wheelchair, crutches, prosthetic limbs) prior to starting chemotherapy. Current exposure to neurotoxic agents (Navelbine, platinums or other taxanes) Pregnancy during chemotherapy treatment Diabetes - diagnosed 3 or more years , or insulin dependent, or with clinically established neuropathy Previous exposure to chemotherapy or radiotherapy HIV positive (high risk for neuropathy) Other neurological diseases, such as Multiple Sclerosis Other pre-existing neuropathy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

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 |
| --- | --- | --- |
| Number of interviews |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer patients
Efficacy and Safety Study of EVERA to Augment Small Breast

Study Overview
=================
Brief Summary
-----------------
Expected Total Number of Subjects Level of significance, alfa 0.05 Power 0.80 Mean difference between two treatments is assumed 35 Standard Deviation is assumed 35. Follow-up loss is assumed 20% N=34(each group:17)

Detailed Description
-----------------
Study design single center, randomized, unblind clinical study Medical device Investigational Medical Device: EVERA Comparator: ESTES Process For eligible subjects, investigator apply Standard Deviation or Comparator on the breast The Investigational Medical Device is determined by randomization. Subjects will be applied for 12 weeks. Subjects will receive Patient Compliance Diary Subjects will visit the hospital to measure breast volume with VIVID 9i every 2 weeks for 16weeks

Official Title
-----------------
A Randomized-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Breast Augmentation With EVERA(Korean External Soft Tissue Expansion System) as Compared to AESTES (American External Soft Tissue Expansion

Conditions
-----------------
Atrophy of Breast

Intervention / Treatment
-----------------
* Device: EVERA
* Device: ESTES


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female aged between 24 and 40 BMI of over 20 Subjects who want to augment breasts Subjects who understand the study contents and signed the informed consent Subjects who can follow study procedure Exclusion Criteria: Pregnant or Lactating subjects

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVERA<br>EVERA- korean ESTES system, apply for 12 weeks | Device: EVERA<br>* EVERA apply for 12 weeks<br>|
| Active Comparator: ESTES<br>ESTES apply for 12 weeks | Device: ESTES<br>* ESTES apply for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in breast volume of the test group and control group |  | Baseline and 12weeks and 16weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in satisfaction level on their breast |  | Baseline and 12weeks and 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
small breast, augmentation, breast volume, External Soft Tissue Expansion System(ESTES)
Electroporation for Cancer Treatment Real World Registry

Study Overview
=================
Brief Summary
-----------------
This registry aims to assess real-world long-term disease outcomes for patients treated using reversible electroporation and a chemotherapeutic or calcium; in particular tumour response rates and recurrence rates. The study also aims to characterise side effects and the occurrence of Adverse Events and their relationship to the treatment.

Official Title
-----------------
Electroporation for Cancer Treatment Real World Registry

Conditions
-----------------
Skin Cancer, Gastrointestinal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient who has been treated using Calcium Electroporation Any patient who has been treated using Electrochemotherapy Patients must be mentally capable of understanding the information given Patients must give written informed consent. Exclusion Criteria: None
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 |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events (CTCAE) | Safety evaluation will be performed via continuous assessment of safety parameters by reviewing events as they arise. The investigation will be put on hold if unacceptable safety issues are outstanding. Adverse Events (AE) and Serious Adverse Events (SAE) will be evaluated and graded according to Common Terminology Criteria for Adverse Events (CTCAE) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Evaluation Criteria in Solid Tumours (RECIST) | A response evaluation will be conducted at standard of care follow up | 3 months, 12 months, 3 years, 5 years | 
| Modified FACE-Q evaluation for Skin Cancers | Cosmesis evaluation will be recorded for skin cancers at standard of care follow up | 3 months, 12 months, 3 years, 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulsed Electric Fields, Reversible Electroporation, Electrochemotherapy, Ca-Electroporation