linjc16/ctgov huggingface dataset:
Magnetic Resonance Post-contrast Vascular Hyperintensities at 3 T: a Sensitive Sign of Vascular Occlusion in Acute Ischaemic Stroke

Study Overview
=================
Brief Summary
-----------------
Magnetic resonance imaging (MRI) is the diagnostic cornerstone for precisely identifying acute ischaemic strokes and locating vascular occlusions. It was observed that a post-contrast three-dimensional turbo-spin-echo T1weighted sequence showed striking post-contrast vascular hyperintensities (PCVH) in ischaemic territories. The aim is to evaluate the prevalence and the meaning of this finding. This study included 130 consecutive patients admitted for acute ischaemic stroke with a 3-T MRI performed in the first 12 h of symptom onset from September 2014 through September 2016. Two neuroradiologists blinded to clinical data analysed the first MRI assessments.

Official Title
-----------------
Magnetic Resonance Post-contrast Vascular Hyperintensities at 3 T: a New Highly Sensitive Sign of Vascular Occlusion in Acute Ischaemic Stroke

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

Intervention / Treatment
-----------------
* Other: MRI images review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients aged 18 and older at onset of an acute ischaemic stroke Availability of at least one pre-therapeutic MRI performed in our centre within 12 h of stroke onset, including a post-contrast 3D TSE T1-weighted sequence. Exclusion criteria: Patients with posterior fossa strokes Patients with known intracranial vasculitis or MoyaMoya disease Presence of severe MR imaging artefacts preventing correct interpretation

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 |
| --- |
|Other: MRI images review|MR images were reviewed by one junior radiologist and one senior neuroradiologist, both blinded to clinical, therapeutic and follow-up data.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overal survival | from the AR-PML diagnosis date to that of death or censored on 31 December 2015 | 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebrovascular disorders, Magnetic resonance imaging, Neuroimaging, Prognosis, Stroke
TIBOLA : Multicenter Descriptive Study in Eastern France

Study Overview
=================
Brief Summary
-----------------
TIBOLA (TIck-BOrne LymphAdenopathy) is a tick-borne disease. The pathogen is most often rickettsia (R. slovaca or R. raoultii), but other strict intracellular bacteria have been described (Francisella tularensis, Coxiella burnetii, Bartonella hensenlae). Transmitted by ticks (Dermacentor), it is characterized by an inoculation eschar at the tick bite site, accompanied by painful loco-regional lymphadenopathy. It is most often a benign pathology, which can nevertheless leave sequellar alopecia or persistent asthenia. In spring 2021, an impression of increased cases was reported by clinicians in Eastern France. The study aims to clarify the clinical-biological presentation and the evolution of the number of cases of TIBOLA in this region between 2016 and 2021. At the same time, entomologists have noted an upsurge in this tick in certain biotopes in recent years.

Official Title
-----------------
TIBOLA : Multicenter Descriptive Study in Eastern France

Conditions
-----------------
TIBOLA, Rickettsia Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person, minor or major, having been diagnosed with TIBOLA between January 1, 2016 and December 31, 2021 at the University Hospital of Nancy or Strasbourg in the departments of infectious and tropical diseases, dermatology, microbiology and pediatrics.
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 |
| --- | --- | --- |
| Number of cases of TIBOLA |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiological and demographic characteristics | gender, age, habitat, hobbies, occupation | baseline | 
| Characteristics of tick bites | frequency, location, date | baseline | 
| Frequency of the various symptoms and clinical signs of the disease | inoculation ulcer, alopecia, lymphadenopathy, asthenia, fever, rash, headache, arthromyalgia, pruritus, facial oedema, other | baseline | 
| Biological results | serology and PCR of rickettsia, non-specific abnormalities | baseline | 
| Treatment | nature, efficiency | baseline | 
| Entomological analysis | respective proportion of Dermacentor and Ixodes encountered on the territory. Detection by molecular biology of the presence of Rickettsia spp. in ticks | evolution between 2016 and 2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dermacentor, DEBONEL
Laser-assisted ICSI Versus Conventional ICSI

Study Overview
=================
Brief Summary
-----------------
Degeneration rate after ICSI is expectable but decreasing it is a goal. Laser-assisted ICSI can serve to decrease this degeneration rate.

Official Title
-----------------
Laser-assisted ICSI Effect on Degeneration Rate After ICSI

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Laser-assisted ICSI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all ICSI cycles Exclusion Criteria: no exclusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser-assisted ICSI<br> | Other: Laser-assisted ICSI<br>* Laser opening of the zona pellucida.<br>|
| No Intervention: conventional ICSI<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oocyte survival after injection |  | 6 days of culture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blastocyst formation rate |  | 6 days of culture | 
| embryo utilization rate |  | 6 days of culture | 
| clinical pregnancy rate |  | four weeks after embryo transfer | 
| ongoing pregnancy rate |  | Twelve weeks of gestation |
SV2A in Older Adults

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to examine the effect of cannabis use on brain synaptic density among older adults using [11C]UCB-J PET imaging.

Official Title
-----------------
Effect of Cannabis Use on Synaptic Density in Older Adults

Conditions
-----------------
Cannabis Use

Intervention / Treatment
-----------------
* Drug: [11C]UCB-J PET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide informed consent Male or female, aged ≥50 years No history of significant medical or neurological disease BMI ≤ 50 If woman of childbearing potential, must agree to use an acceptable method of birth control, as determined by the principal investigator, for the duration of the study and up to one month after completion of PET scans Exclusion Criteria: Women with a positive pregnancy test or women who are lactating Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits; History of a bleeding disorder or are currently taking anticoagulants Subjects who have donated blood within 8 weeks of the present study

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cannabis using older adults<br>Subjects undergo a single PET scan using [11C]UCB-J | Drug: [11C]UCB-J PET<br>* Single PET scan using the radioligand [11C]UCB-J<br>|
| Other: Healthy controls<br>Subjects undergo a single PET scan using [11C]UCB-J | Drug: [11C]UCB-J PET<br>* Single PET scan using the radioligand [11C]UCB-J<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hippocampal synaptic density | Measure of synaptic density in the hippocampus | 1 month |
Pituitary Function and Spontaneous Intracranial Hypotension

Study Overview
=================
Brief Summary
-----------------
Previous research has identified spontaneous cerebral spinal fluid leakage as a cause for spontaneous intracranial hypotension, leading to positional headache patterns. Typical magnetic resonance imaging findings include subdural fluid collections, enhancement of pachymenginges, engorgement of venous structures, pituitary hyperemia, and sagging of the brain (SEEPS). Because pituitary hyperemia has been documented in cases of spontaneous cerebral spinal fluid leakage and is known to mimic a pituitary tumor or hyperplasia, the investigators would like to like to assess the clinical manifestations and neuroimaging abnormalities of SIH patients with regard to the pituitary gland. Specifically, the investigators are looking to analyze the compression of the pituitary stalk and conduct a systemic evaluation of pituitary function in SIH patients.

Official Title
-----------------
Spontaneous Spinal Cerebrospinal Fluid Leaks and Intracranial Hypotension

Conditions
-----------------
Hyperprolactinemia, Spontaneous Intracranial Hypotension

Intervention / Treatment
-----------------
* Other: Pituitary panel will be drawn pre-op and post-op for all patients.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients Age 18 years and older Diagnosis of SIH: LP Brain MRI (SEEPS) Exclusion Criteria: Pregnant and post-partum females Nursing mothers Patients with potential hyperprolactinemia due to: Hypothyroidism, Chronic renal disorder Liver disease (including cirrhosis) Primary or secondary amenorrhea Polycystic Ovary Syndrome Seizure disorder Illicit drug use

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 |
| --- | --- |
| Surgery or Blood Patch<br> | Other: Pituitary panel will be drawn pre-op and post-op for all patients.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the levels of prolactin pre and post treatment |  | 90 days |
Nit-Occlud PDA Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
The Nit-Occlud PDA Post-Approval Study is designed to continue to evaluate the safety and effectiveness of the device in the post-approval phase.

Official Title
-----------------
Nit-Occlud PDA Post-Approval Study

Conditions
-----------------
Patent Ductus Arteriosus (PDA)

Intervention / Treatment
-----------------
* Device: PDA Coil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Angiographically confirmed PDA with minimum diameter < 4 mm. Weight is ≥ 5 kg. Age 6 months to 21 years. Exclusion Criteria: Cardiac anomalies requiring surgery. Known bleeding or coagulation disorder. Febrile illness within 7 days of planned procedure. Pregnancy. Pulmonary hypertension with increased pulmonary vascular resistance (≥ 5 Wood Units). Hypersensitivity to contrast medium. Known nickel allergy.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 21 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 |
| --- | --- |
| PDA Coil<br>Patients age 6 months to 21 years weighing > 5kg with an angiographically confirmed PDA with a minimum diameter of < 4 mm. | Device: PDA Coil<br>* The Nit-Occlud PDA is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter < 4 mm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Serious Device and/or Procedure Related Adverse Events as a Measure of Safety | The primary safety endpoint is to demonstrate the 24-month serious device-related adverse event rate is no worse than the objective-performance criterion (OPC) of 1%. | 24 months (2 year) | 
| Rate of Complete PDA Closure as a Measure of Efficacy | The primary effectiveness endpoint is to demonstrate the 12-month (1 year) complete closure rate for the device is no worse than the OPC of 85%. The closure of the ductus arteriosus will be assessed by absence of residual flow at 12 months (1 year) by transthoracic echocardiogram with 2-D color flow mapping and pulse wave Doppler (ECHO). | 12 months (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Device and/or Procedure Related Adverse Events as a Measure of Safety | The secondary safety endpoint is to demonstrate that the rate of device-related adverse events reported through 24-months post procedure is no worse than 6% (OPC rate of 3% plus an added 3% margin). | 24 months (2 year) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Occluder
A Clinical Study of Lyophilized Plasma in Patients on Warfarin

Study Overview
=================
Brief Summary
-----------------
This is a multi center, phase 2 randomized controlled study to determine the effect of lyophilized plasma in patients on warfarin therapy.

Official Title
-----------------
A Phase II Clinical Study of Lyophilized Plasma in Patients on Warfarin

Conditions
-----------------
Anticoagulant Therapy

Intervention / Treatment
-----------------
* Biological: Lyophilized Plasma
* Biological: Licensed Plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients receiving oral anticoagulation with warfarin derived agents. Patients who have need for urgent surgery, an invasive procedure or identification of a patient with active bleeding where oral or parenteral vitamin K therapy is deemed too slow in its action for reversal of warfarin anticoagulant effects. Patients with an elevated international normalized ratio. Exclusion Criteria Patients who are clinically unstable. Patients who have congenital or acquired coagulopathies (other than warfarin therapy). Patients who have received medications that could interfere with the results of laboratory testing. Pregnant or nursing women. Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion. Patients previously enrolled in this study. Active illicit drug use.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Licensed Plasma<br> | Biological: Licensed Plasma<br>* Plasma that has been authorized for transfusion.<br>|
| Experimental: Lyophilized Plasma<br> | Biological: Lyophilized Plasma<br>* Licensed plasma that has been lyophilized.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess and Compare Adverse Events | The primary safety objective is to assess the adverse events after infusion of lyophilized plasma compared to control. | Duration of Study (Less than or equal to 72 hours) |
Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.

Study Overview
=================
Brief Summary
-----------------
The study investigates effects related to muscle protein metabolism at provision of Total Parenteral nutrition.

Detailed Description
-----------------
Randomized study investigating alterations in muscle protein metabolism at provision of parenteral nutrition. The study uses a genomic/transcriptomic/proteomic approach to evaluate factors related to activation of skeletal muscle protein synthesis. Patients scheduled for major gastrointestinal surgery are included. Muscle specimens are collected during surgery.

Official Title
-----------------
Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.

Conditions
-----------------
Wasting;Muscle(S)

Intervention / Treatment
-----------------
* Drug: TPN
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major gastrointestinal surgery Assumed need of post-operative artificial nutrition. Exclusion Criteria: Insulin dependent diabetes Steroid medication

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total Parenteral Nutrition (TPN)<br>Overnight infusion of Parenteral Nutrition supplied in all-in one bag -format. Infusion-rate of 0.16 gram Nitrogen/kg/day. | Drug: TPN<br> <br> * Other names: TPN infusion;|
| Placebo Comparator: Control (saline infusion)<br>Overnight infusion of physiological saline at the same infusion-rate; ml/kg as intervention (TPN). | Other: Control<br> <br> * Other names: Physiological saline infusion;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle protein metabolism | Alterations in muscle protein metabolism will be assessed by various standard techniques for gene and protein expression. Combined measurements of cell-signaling molecules representing anabolic and catabolic signaling pathways will be evaluated in relation to transcription of muscle myosin proteins. | Single evaluation point at 12-14 hours following the start of overnight infusion. |
A Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Insulin Infusion in Patients With Type I Diabetes

Study Overview
=================
Brief Summary
-----------------
This crossover, glucose-clamp study will investigate the impact of different basal insulin infusion rates on glucose control employing insulin pumps with different insulin delivery regimen. Patients will be randomized in one of 2 groups, to receive on the first study day insulin via pumps with pulsatile or quasi-continuous delivery modes. On the second study day they will be switched to treatment with the alternative delivery regimen. The anticipated duration of the trial is 2 study days and the target sample size is 14 individuals.

Official Title
-----------------
A Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Insulin Infusion in Patients With Type I Diabetes

Conditions
-----------------
Diabetes Mellitus Type 1

Intervention / Treatment
-----------------
* Device: Accu-Chek Spirit Insulin Pump
* Device: Comparator insulin pump


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients 18-65 years of age Type I diabetes mellitus Currently on continuous subcutaneous insulin infusion therapy Exclusion Criteria: Proliferative retinopathy or maculopathy requiring actue treatment within last 6 months Use of systemic corticoids in last 3 months Treatment with medication known to interfere with glucose metabolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Device: Accu-Chek Spirit Insulin Pump<br> <br> |
| Active Comparator: B<br> | Device: Comparator insulin pump<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of glucose infusion rate necessary to keep blood glucose constant |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum insulin and free fatty acid levels |  | Throughout study |