linjc16/ctgov huggingface dataset:
Severe Leptospirosis in Non-tropical Areas

Study Overview
=================
Brief Summary
-----------------
Leptospirosis is a worldwide zoonosis. The mortality of the disease is between 3,6% to 13%, and up to 48% for the severe leptospirosis. Only few studies exist on severe leptospirosis and none major multicentre on leptospirosis in intensive care units in Europe. The investigators conduct a retrospective multi centric study in metropolitan France in order to identify the characteristic, the treatments and the prognostic factors associated with mortality of sever leptospirosis.

Detailed Description
-----------------
Leptospirosis is a worldwide zoonosis. The infection is acquired through contact with animal urine on contaminated soil. It is an important remerging infectious disease because of its increasing incidence. Leptospirosis is most common in tropical and rural settings but its incidence has been constantly increasing for the past ten years in Metropolitan France. Most of the cases are asymptomatic or sparsely symptomatic, but some patients develop severe leptospirosis (6% to 59%), requiring hospitalisation in intensive care units. The mortality of the disease is between 3,6% to 13%, and up to 48% for the severe leptospirosis. Only few studies exist on severe leptospirosis and none major multicentre on leptospirosis in intensive care units in Europe. Therefore, the investigators have decided to carry out this studies. The investigators conduct a retrospective multi centric study in metropolitan France in order to identify the characteristic, the treatments and the prognostic factors associated with mortality of sever leptospirosis.

Official Title
-----------------
Severe Leptospirosis in Non-tropical Areas: a Nationwide, Multicentre, Retrospective Study in French ICUs

Conditions
-----------------
Leptospirosis, Intensive Care Unit, Epidemiology, Alveolar Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted in ICU Leptospirosis confirmed with one laboratory test (MAT, ELISA, PCR, direct examination) Exclusion Criteria: No specific exclusion criteria

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 |
| --- | --- |
| Patient admitted in the ICU for leptospirosis<br>Patient admitted in the ICU for leptospirosis None intervention was performed according to retrospective design | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at ICU discharge | Mortality was evaluated at ICU discharge | ICU discharge (usually 5 days) |
Stronger Together Global Registry

Study Overview
=================
Brief Summary
-----------------
A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products.

Detailed Description
-----------------
To gain observational, prospective, real-world clinical, and radiographic data in order to evaluate continued safety and performance following the implantation of SeaSpine products.

Official Title
-----------------
Evaluating Real-World Spine Outcomes for Spinal and Orthobiologics Products From Around the World

Conditions
-----------------
Spinal Disease

Intervention / Treatment
-----------------
* Device: Spinal Surgery with SeaSpine product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have been treated with at least one SeaSpine product. Have obtained radiographic imaging, as part of the standard of care, at the following time points: preoperative and postoperative. Have obtained at least one preoperative patient-reported outcome measure, as part of the standard of care. Patient is planned, per standard of care, to be assessed with radiographic imaging and consistent patient-reported outcome measure(s) from preoperative through at least two scheduled follow-up visits. Exclusion Criteria: Was not implanted with at least one SeaSpine product during operation Any other condition that the Investigator determines is unacceptable for enrollment into this registry
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Implanted with SeaSpine spinal or orthobiologics product<br>Standard of Care Registry- Patients must have been implanted with at least one SeaSpine product | Device: Spinal Surgery with SeaSpine product<br>* Implanted with SeaSpine spinal or orthobiologic product<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of product failure | Product failure is defined as product fracture, loosening, gross migration and/or dissociation. | 12 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of product-related Serious Adverse Events (SAEs) related to the spine, fusion or bone healing, and intraoperative and postoperative unanticipated adverse device effects | Product-related SAEs related to the spine, fusion, or bone will be collected for this outcome measure. | Intra-operative to 24 months |
A Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects

Study Overview
=================
Brief Summary
-----------------
The study aims to assess the biological potency of the In-House Reference Preparation (IHRP) of peanut allergens extract by a quantitative Skin Prick Test (SPT) method in peanut-allergic subjects.

Official Title
-----------------
An Open-label Phase I Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects

Conditions
-----------------
Peanut Allergy

Intervention / Treatment
-----------------
* Drug: DBV712 IHRP


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Male or female subjects aged between 12-50 years Physician-diagnosed peanut allergy Subject currently following a strict peanut-free diet Documented history of positive test to peanut-specific IgE (ImmunoCAP system) >0.7 kU/L Positive peanut SPT with a largest wheal diameter ≥ 8 mm Main Exclusion Criteria: Uncontrolled asthma Peanut allergen immunotherapy whatever the route, either ongoing or previously started and having lasted more than one month (>30 days) Topical use of steroids within the past 14 days prior to the Screening SPT Inability to discontinue short-acting antihistamines Atopic dermatitis, eczema or urticaria on the areas to be tested

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DBV712 Solution for Skin Prick Test<br>DBV712 In-House Reference Skin Prick Test preparation | Drug: DBV712 IHRP<br>* DBV712 Solution for Skin Prick Test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological potency of the In-House Reference peanut proteins extract (DBV712-IHRP) in arbitrary Biological Units (BU) |  | 1 day to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) |  | Throughout the study (1 day to 2 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EPIT, Epicutaneous, Immunotherapy, Viaskin
Validation of the Utility of Strabismus Intelligent Diagnostic System

Study Overview
=================
Brief Summary
-----------------
Strabismus affects approximately 0.8%-6.8% of the world's population and appears by the age of 3 years in 65% of affected individuals. Manual measurement of deviation is often laborious and highly dependent on the experience of the specialist and the cooperation of the patients. Current strabismus evaluation technologies are heavily dependent on model eyes. Here, the investigators use deep learning to develop an artificial intelligence (AI) platform consisting of three deep learning (DL) systems to screen strabismus, evaluate deviation and propose a surgical plan based on corneal light-reflection photos. The investigator also conduct clinical trial to validate its versatility in clinical practice.

Official Title
-----------------
Validation of the Utility of Strabismus Intelligent Diagnostic System: A Clinical Trial

Conditions
-----------------
Ophthalmological Disorder, Strabismus

Intervention / Treatment
-----------------
* Drug: Strabismus diagnostic system.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in the outpatient clinic of strabismus department. Exclusion Criteria: Patients or their parents diagree to participate in the trial. Patients with blepharoptosis. Patients can't facing forward or lacking fixation.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eligible patients for AI test<br>Device: strabismus diagnostic system. | Drug: Strabismus diagnostic system.<br>* An AI platform based on corneal light-reflection photos to facilitate the diagnosis and angle evaluation of strabismus and to provide advice for surgical planning.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of accurate, mistaken and miss detection of the diagnostic system. |  | up to 3 years |
A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients

Study Overview
=================
Brief Summary
-----------------
The main aim of this clinical study is to investigate whether the blood concentration of methotrexate changes when AZD9056 is co- administered together with methotrexate.

Official Title
-----------------
A Phase I, Multi-centre, Open-label, Fixed-sequence Study to Assess the Pharmacokinetics of Methotrexate Alone and When Co-administered With AZD9056 in Subjects With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: AZD9056
* Drug: Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with rheumatoid arthritis Currently on Methotrexate treatment Provision of informed consent Exclusion Criteria: History of malignancy (except for treated squamous and basal cell carcinoma of the skin more than 5 years prior to entry) Patients who were taking prescription of medications listed below: Medications that are hepatic enzyme inducers and that were inhibitors of cytochrome P450, Lovastatin Leflunomide, hydroxychloroquine, cyclosporin or anti-tumour necrosis factor therapies within 90 days of Visit 1, or treatment with rituximab within 1 year before Visit 1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>AZD9056 400 mg and Methotrexate | Drug: AZD9056<br>* Tablets for oral use. 400 mg once daily for 7 days<br>Drug: Methotrexate<br>* Tablet for oral use.7.5 to 20 mg single dose administration at visit 2 and 3.<br>* Other names: Various brands used;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of AZD9056 and Methotrexate |  | Pharmacokinetic samples for Methotrexate taken at baseline and and at steady state.Pharmacokinetc samples for AZD9056 taken at steady state | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of AZD9056 and 7-OH Methotrexate |  | Pharmacokinetics samples for 7-OH Methotrexate taken at baseline and and at steady state.Pharmacokinetc samples for AZD9056 taken at steady state | 
| Safety and tolerability (Physical examination, vital signs, electrocardiogram (ECG), safety laboratory,adverse events.) |  | During the whole study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AZD9056, Pharmacokinetics, interaction, Methotrexate, Rheumatoid Arthritis
Pituitary Histopathology and Hyperprolactinaemia and Risk of Glucose Metabolic Disturbances in Acromegaly.

Study Overview
=================
Brief Summary
-----------------
Acromegaly is frequently associated with impaired glucose tolerance and diabetes. We hypothesise that pituitary histopathology and plasma hyperprolactinaemia could have prognostic value in predicting the risk of glucose metabolic disturbances in acromegalic patients. The aim of this study is to examine glucose metabolic outcome in acromegalic patients with and without histologically verified prolactin and growth hormone (GH) co-secreting adenomas. The study population include 79 patients who have all undergone surgical treatment for acromegaly.

Detailed Description
-----------------
Acromegaly is frequently associated with impaired glucose tolerance and diabetes. We hypothesise that pituitary histopathology and plasma hyperprolactinaemia could have prognostic value in predicting the risk of glucose metabolic disturbances in acromegalic patients. The aim of this study is to examine glucose metabolic outcome in acromegalic patients with and without histologically verified prolactin and growth hormone (GH) co-secreting adenomas. 79 patients who have all undergone surgical treatment for acromegaly are included. Clinical and biochemical baseline data are collected from medical records. Patients are divided into two groups based on histopathological evaluation of pituitary adenomas; pure GH secreting adenomas or GH and prolactin co-secreting adenomas.

Official Title
-----------------
Prognostic Value of Pituitary Histopathology and Plasma Hyperprolactinaemia in Predicting the Risk of Glucose Metabolic Disturbances in Patients With Acromegaly.

Conditions
-----------------
Acromegaly, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of acromegaly, and treated at the department of Endocrinology, Copenhagen University Hospital, Rigshospitalet, Denmark (tertiary referral hospital), surgical treatment of acromegaly Exclusion Criteria: no surgical treatment performed

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 |
| --- | --- |
| Acromegaly<br>Patients with acromegaly who have received surgical treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate glucose metabolic outcome related to pituitary histopathology and plasma hyperprolactinaemia in patients with acromegaly | Patients are grouped according to histopathological evaluation of pituitary adenomas pure GH secreting adenomas or GH and prolactin co-secreting adenomas. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acromegaly, surgery, histopathology, hyperprolactinaemia,
Efficiency Comparison Between Methylprednisolone and Phenol 8% Treatment Using a Trans Sacral Approach - on Lower Back Pain and Limbs

Study Overview
=================
Brief Summary
-----------------
The American Society of Anesthesiologists Task Force on Management, Chronic Pain section, recommended Phenol neurolysis when other techniques have failed to provide adequate pain control. In this study we sought to Compare the pain relieve on a Lower Back and Limbs obtained from Methylprednisolone and Phenol 8% Treatment given by Trans Sacral Approach. The study includes patients who suffers from a chronic low back and/or limbs pain which were referred to be given epidural as a treatment. Control group receives 80 mg Methylprednisolone while the test group receives phenol 8%.

Official Title
-----------------
Efficiency Comparison Between Methylprednisolone and Phenol 8% Treatment Using a Trans Sacral Approach - on Lower Back Pain and Limbs

Conditions
-----------------
Back Pain

Intervention / Treatment
-----------------
* Drug: phenol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -at least 18 years of age; chronic low back pain of at least 12 weeks duration; patients which were diagnosed as a candidate for epidural since other techniques have failed to provide adequate pain control Sciatica due to Lumbar Disc Herniation Neurogenic Claudication due to Lumbar Spinal Stenosis Exclusion Criteria: patients with unbalanced high blood pressure patients who can not ley prone patients who consumes anti-clotting medications patients with bleeding problems patients with Diabetes patients who suffers from chronic non-specific lower back and limb pain

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: phenol|1 cc of 8% phenol dissolved in water or 20cc of 8o mg Methylprednisolone diluted in 0.25% marcaine.|

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
-----------------
Methylprednisolone, trans sacral block, phenol
Microsurgery in the Elderly in a Private Practice Setting

Study Overview
=================
Brief Summary
-----------------
This study reports the experience in free tissue transfer in the elderly population by a single surgeon in the private practice setting in Mexico city and the potential criticism that could arise from adverse events in lower-volume practice situations will be addressed. Investigator will answer the question about the age as the variable of interest in this series in which age was not a factor in deciding reconstructive methods, and examine complication rates.

Detailed Description
-----------------
Investigators will evaluate the outcomes of 17 flaps in 14 patients who required microsurgical reconstruction with free flaps and microvascular vessels anastomosis. All patients more than 65 years old. Demographic data will be reported as: obesity, American Society of Anesthesiology (asa) level, radiotherapy, combined surgery. And the results of investigation will include: Flap survival, local complications, systemic complications, re-interventions, 30-day mortality.

Official Title
-----------------
Outcomes of Microsurgical Reconstruction in the Elderly Patient in a Private Practice Setting in México City: Case Series

Conditions
-----------------
Aged, Microsurgery

Intervention / Treatment
-----------------
* Other: Observation of flap survival and complications


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elderly population, defined as more than 65 years old Patients underwent to free flap microsurgical procedures. Complete files Patient acceptance to participate Exclusion Criteria: Lost follow up

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 95 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observation of flap survival and complications|We will report the flap survival and complications in this population group underwent to microsurgical procedures in a private practice setting|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flap survival | Evaluation of success of microsurgical free flap. Flap necrosis or not | 1 month | 
| Complications | Report the number and type of local and systemic complications in this microsurgical procedures. | 1 month |