linjc16/ctgov huggingface dataset:
Characterization of Immunosuppressive Signing of Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
Infection with Human Papillomavirus high-risk Human (HR-HPV) is the main factor of risk of cancer of the cervix. Recent studies show that cancers linked to infection with HR-HPV are associated with immunosuppression and lack of T cell response Such mechanisms would promote progression to cancer and progression of it . Various factors such as an increase of regulatory T cells, the presence of myeloid cells and suppressor of defects in the signaling pathway Toll Like Receptor (TLR) may have a key role in these immunosuppression mechanisms. At this stage of knowledge, a better characterization of local and systemic immunosuppressive signing of cervical cancer is needed. The results should have a significant medical impact for the identification of new prognostic markers and new therapeutic targets for the treatment of patients with cervical cancer. The aim of this research project is to define the signing of immunosuppressive cancer cervix and analyze the different mechanisms involved in this immunosuppression.

Official Title
-----------------
Characterization of Immunosuppressive Signing of Cervical Cancer

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Biological: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The women presenting for initial therapeutic management of cervical cancer Elderly patients over 18 years Patients beneficiary of a social security scheme Pregnant women can not participate in this study Women known to be HIV positive will not participate in this study Exclusion Criteria: Patients with a recurrence of a treaty cervical cancer Patients with a history of pelvic radiotherapy Patients unable to receive informed about the progress and objectives of the study Patients not receiving a social security scheme Patients who have not signed informed consent Immunocompromised patients and pregnant women

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with invasive cervical cancer<br>Blood sample | Biological: Blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lack of tumor emboli histological analysis | Patients with good prognosis of cervical cancer | 60 months |
Toronto Gestational Glucose Tolerance Cohort

Study Overview
=================
Brief Summary
-----------------
In this prospective observational cohort study, women representing the full spectrum of gestational glucose tolerance status are undergoing longitudinal cardiometabolic characterization at regular intervals in the years after the index pregnancy.

Detailed Description
-----------------
In this prospective observational cohort study, women reflecting the full spectrum of glucose tolerance in pregnancy (from gestational diabetes mellitus (GDM) to lesser degrees of gestational glucose intolerance to those with completely normal glucose tolerance) are being recruited in late 2nd trimester. This cohort of women thus carries a broad range of risk for the future development of type 2 diabetes (T2DM) and cardiovascular disease. At regular intervals in the years after the index pregnancy, this cohort of women is undergoing serial cardiometabolic characterization, including assessment of glucose tolerance, beta-cell function and insulin sensitivity. The longitudinal changes over time in this cohort should provide insight into the early pathophysiology and natural history of T2DM and cardiovascular disease.

Official Title
-----------------
Toronto Gestational Glucose Tolerance Cohort

Conditions
-----------------
Type 2 Diabetes, Gestational Diabetes, Pre-diabetes

Intervention / Treatment
-----------------
* Other: There is no intervention. An exposure of interest is glucose tolerance status in pregnancy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women Exclusion Criteria: Pre-existing diabetes before the index pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: There is no intervention. An exposure of interest is glucose tolerance status in pregnancy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose tolerance status | Glucose tolerance is assessed on oral glucose tolerance test | 10 years after pregnancy |
Abnormalities of B Lymphocytes During Systemic Lupus

Study Overview
=================
Brief Summary
-----------------
Previous experimental data strongly suggest that B lymphocytes have intrinsic abnormalities during lupus in mice spontaneously affected by the disease. This study tries to define these abnormalities by looking at the gene expression profile of purified B lymphocytes from patients with non active systemic lupus , compared with the gene expression profile of purified B lymphocytes from healthy donnors.

Official Title
-----------------
Phenotypic Characteristics and Transcriptomas of B Lymphocytes During Non Active Systemic Lupus Erythematosus

Conditions
-----------------
Systemic Lupus Erythematosus

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: non active systemic lupus Exclusion criteria: immunosuppressive drugs more than 10 mg of prednisone per day

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

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

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

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

Design Details

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


Arms and Interventions

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

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
-----------------
Systemic lupus, B lymphocytes, transcriptomas
Prevalence Study of the Etiology of Pregnancy Anemia

Study Overview
=================
Brief Summary
-----------------
Anemia during pregnancy occurs in 41% of women. The most common etiology is iron deficiency, but studies to determine prevalence of other causes of anemia in pregnancy are still lacking. However, anemia in pregnancy lead to adverse pregnancy outcomes and increase risk of maternal and fœtal morbidity and mortality. Specific management of anemia is so needed.

Official Title
-----------------
Prevalence Study of the Etiologies of Pregnancy Anemias

Conditions
-----------------
Pregnancy Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: woman 18-years or older woman with a normal pregnancy anemia with accidental or symptomatic discovery, whatever the term of pregnancy non opposition collected Exclusion Criteria: Refuse to participate Stopped pregnancy whatever the term Medical abortion of pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Prevalence of the etiologies of anemias occured during pregnancy | Anemia in pregnancy is defined as hemoglobin level (Hb) < 11 g/dL in the first and the third trimesters, and Hb < 10.5 g/dL in the second trimester. | from date of inclusion until 6 weeks after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of obstetrical complications in women with anemia | Measure of the incidence of postpartum haemorrhage, instrumental extractions, caesareans sections, premature delivery, intra-uterine growth restriction or small for gestational age, placenta abruption, preeclampsia and low birth-weight newborn (<3rd and <10th percentile under neonatal morphometry curves) Level of release, 1-, 3- and 5-minutes Apgar score, Arterial ans venous cord potential hydrogen (pH) | from date of inclusion until delivery | 
| Study of the evolution of anemia during pregnancy and postpartum | Measure of the Hb level monthly and at 6 weeks after delivery | from date of inclusion until 6 weeks after delivery | 
| Describe the etiological and therapeutic management of pregnancy anemias | therapeutic management : etiologic treatment (supplemental iron, vitaminic replacement, others) and symptomatic treatment (numbers and rhythm of transfusions) | from date of inclusion until 6 weeks after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy Anemia
Levitra® - Real Life Safety and Efficacy of Levitra

Study Overview
=================
Brief Summary
-----------------
Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily life conditions in a large number of subjects with erectile dysfunction (ED)

Official Title
-----------------
REALISE Levitra® - Real Life Safety and Efficacy of Levitra

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Levitra (Vardenafil, BAY38-9456)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male outpatients >/= 18 years of age with a diagnosis of ED according to the 1992 US National Institutes of Health (NIH) Consensus Statement (the inability to achieve and maintain penile erection sufficient to complete satisfactory intercourse), and independent of any previous ED treatment Exclusion Criteria: Exclusion according to US PI

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

Sexes Eligible for Study
-----------------
Male

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: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* Treatment according to US PI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Erectile Disfunction |  | 8 weeks | 
| Onset of Drug Effect |  | 8 weeks | 
| Second successful intercourse |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Safety Parameters |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile Dysfunction, Vardenafil
Intra-articular Betamethasone and the Hypothalamic-pituitary-adrenal Axis

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of intra-articular corticosteroid injection (IACI) of depot preparation of betamethasone on the hypothalamic-pituitary-adrenal (HPA) axis, in patients with osteoarthritis of the knee

Detailed Description
-----------------
Consecutive patients attending the rheumatology or orthopedic clinic with osteoarthritic knee pain, not responding satisfactorily to medical or physical therapy were allocated to group-1 after consent and given IACI of 6 mg of betamethasone acetate/betamethasone sodium phosphate. Following completion of this part, consecutive age- and sex-matched patients were allocated to group-2 and given intra-articular injection of 60 mg of sodium hyaluronate. Just prior to the knee injection and 1, 2, 3, 4 and 8 weeks later, patients had 1 µg adrenocorticotropin hormone (ACTH) stimulation test. Secondary adrenal insufficiency (SAI) was defined as levels of less than 18 ng/ml or a rise of < than 7 ng/ml of serum cortisol, 30 minutes following the ACTH stimulation test.

Official Title
-----------------
The Effect of Intra-articular Injection of Betamethasone Acetate/Betamethasone Sodium Phosphate at the Knee Joint on the Hypothalamic-pituitary-adrenal Axis: a Case Controlled Study

Conditions
-----------------
Adrenal Suppression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoarthritis of the knee Exclusion Criteria: Had steroids in the last 3 months. Allergic to steroids

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 |
| --- | --- |
| betamethasone<br>Patients who had intra-articular injection of betamethasone | |
| Hyaluronic acid<br>Patients who had intra-articular injection of hyaluronic acid | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adrenal Suppression | Adrenal gland suupresion and inability to adequately secrete cortisol in response to stress | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| favorable clinical response |  | 2 months | 
| Favorable clinical response | Improvement of knee pain by more than 30 points according to visual analogue scale | 2 months following the steroid injection |
A Prospective Analysis of the Effect of Therapeutic Hypothermia After Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
Therapeutic hypothermia has been shown to improve survival and neurologic outcome in patients resuscitated after ventricular fibrillation arrest. Few studies have examined whether therapeutic hypothermia is effective outside the research setting, or with other presenting rhythms. Our institution, a large community teaching hospital, instituted a therapeutic hypothermia protocol in November 2006 for all resuscitated cardiac arrest patients. The investigators seek to determine the mortality rate of our protocol and compare our complication rates with those of previously published studies.

Detailed Description
-----------------
The use of therapeutic hypothermia has been shown to have a beneficial effect on neurologic outcomes of patients resuscitated from cardiac arrest in a limited number of clinical sites. Based on available data, current recommendations from the American Heart Association include a level 2a endorsement of therapeutic hypothermia for cardiac arrest from ventricular fibrillation with persistent coma, and a level 2b recommendation for cardiac arrest from any other rhythm. To date there have been no formal studies presented that demonstrate an improvement in outcome when a hypothermic protocol is implemented in a community hospital. The investigators plan to prospectively collect data on patients enrolled in the therapeutic hypothermia protocol to evaluate clinical outcomes and compare these outcomes with historic controls, with the hypothesis that patients enrolled in the hypothermic protocol will have improved neurologic outcomes.

Official Title
-----------------
A Prospective Analysis of the Effect of Therapeutic Hypothermia After Cardiac Arrest

Conditions
-----------------
Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any adult non-pregnant patient who is unresponsive after resuscitation from cardiac arrest regardless of presenting rhythm and who survives to hospital admission. Exclusion Criteria: hypotension (SBP <90), initial temperature < 30 °C, trauma, primary intracranial event, or active coagulopathy.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
therapeutic hypothermia
Phase 4 Study in the Elderly Patients With T2DM

Study Overview
=================
Brief Summary
-----------------
The study will assess the incidence of Hypoglycemia: Percent of patients presenting no hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM patients treated with a DPP-4 inhibitor or another OAD as add-on therapy to metformin

Official Title
-----------------
A Multicenter, Prospective, Randomized, Open-label, Parallel Group Study to Investigate the Clinical Benefit on Hypoglycemia Frequency of 24 Weeks Treatment With Galvus Versus Usual Care (Any OAD of Another Class Added to Metformin Within SmPc) in Older Patients With Type 2 Diabetes Insufficiently Controlled by Metformin Monotherapy.

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

Intervention / Treatment
-----------------
* Drug: Vildagliptin
* Drug: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Mellitus (DM) patients aged 65 to 80 years, willing to perform SMBG in case of symptomatic hypoglycemia. HbA1c: 6.5 to 8.5 % with max tolerated dose of metformin monotherapy for at least 3 months. Exclusion Criteria: Age > 80 yrs BMI < 22 and ≥ 45 kg/m2 Secondary T2 DM Hepatic failure, moderate/severe renal failure (Cl < 50 ml/min) and CHF III & IV ASAT / ALAT > 3 ULN, creatinine clearance < 50 ml/min Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin<br> | Drug: Vildagliptin<br> <br> |
| Active Comparator: other Oral Antidiabetic Drug in a different therapeutic class<br> | Drug: Usual Care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients in each of the two treatment groups presenting no hypoglycemia (confirmed events with SMBG and severe episodes) after 24 wk of randomized therapy added to their ongoing metformin background therapy. |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients reaching their therapeutic goal |  | 24 weeks | 
| Percent of patients with success of primary EP (no confirmed/severe hypoglycemia) and reaching their therapeutic goal |  | 24 weeks | 
| Glycemic control assessed by A1C, and the mean of 6 Points self-monitoring of blood glucose (SMBG) at baseline and after 24 weeks. |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, vildagliptin, hypoglycemia, elderly
Glistenings and PCO Evaluation for the Envista MX60

Study Overview
=================
Brief Summary
-----------------
Posterior capsule opacification (PCO) and glistenings development is among the primary reasons for sub-optimal visual capacity following cataract extraction surgery. Primary objective of this study is to evaluate the incidence of PCO and glistenings of the popular envista MX-60 intraocular lens (Bausch + Lomb) in a random sample of cataract patients who underwent phacoemulsification at least 1 year prior to their enrollment at the study

Official Title
-----------------
Evaluation of Glistenings and Posterior Capsule Opacification Following Envista MX60 Intraocular Lens Implantation

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Procedure: Phacoemulsification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of senile cataract with stage 3 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale Exclusion Criteria: Endothelial cell count less than 1900, glaucoma, IOP-lowering medications, former incisional surgery, former diagnosis of corneal disease, diabetes or autoimmune diseases

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 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 |
| --- | --- |
| Study Group<br>Participants who underwent phacoemulsification surgery and implantation of the Envista MX-60 IOL | Procedure: Phacoemulsification<br>* Phacoemulsification for cataract extraction with Envista MX-60 implantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glistenings | Evaluation of glistenings using Scheimpflug analysis | 1 year | 
| Posterior capsule Opacification (PCO) | Evaluation of PCO using EPCO software | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract; intraocular lens; posterior capsule opacification; glistening; ENVISTA