linjc16/ctgov huggingface dataset:
Brain Perfusion in Pantothenate Kinase-associated Neurodegeneration (PKAN)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn whether blood flow in the brain is normal in people with pantothenate kinase-associated neurodegeneration (PKAN). Specifically, preliminary data suggest a region of the brain called the globus pallidus (GP), a key region affected by PKAN, may have reduced blood flow. Standard MRI and perfusion scanning techniques will be used to learn about cerebral blood flow in the globus pallidus and compare it to blood flow in other brain regions as well as to healthy controls.

Official Title
-----------------
Brain Perfusion in Pantothenate Kinase-Associated Neurodegeneration (PKAN)

Conditions
-----------------
Pantothenate Kinase-associated Neurodegeneration (PKAN)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of PKAN confirmed by MRI and gene testing able to undergo MRI for approximately 1 hour without sedation Exclusion Criteria: deep brain stimulators or other conditions that warrant avoidance of a strong magnetic field previous reaction to gadolinium (Gd) contrast agent acute or chronic kidney dysfunction pregnant and/or nursing at time of study

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 75 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 |
| --- | --- |
| PKAN<br>This group consists of individuals diagnosed with PKAN using a combination of MRI and PANK2 gene sequencing. | |
| Healthy volunteers<br>This is a control group of healthy volunteers, matched with the PKAN group for age and sex. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASL-derived cerebral blood flow(CBF) | The unit of analyses will be the subject and the primary comparison will be the globus pallidus CBF between PKAN and healthy controls. | Single MRI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PKAN, brain iron, NBIA, neurodegeneration with brain iron accumulation, Hallervorden Spatz Syndrome
Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department

Study Overview
=================
Brief Summary
-----------------
This study is attached to a comprehensive quality assurance/quality improvement (QA/QI) program conducted by the Office of the medical director, and is designed to contribute to generalizable knowledge to determine effectiveness and tolerability of an FDA approved Impedance Threshold Device (ITD) device in a large urban emergency medical service (EMS) system. The cohort will comprise a convenience sample of patients that are being treated by EMS for a hypotensive emergency.

Conditions
-----------------
Acute Hypotension

Intervention / Treatment
-----------------
* Device: ResQGARD ITD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults between the ages of 18-120 years presenting to EMS with or development of Hypotension during EMS interaction treated by EMS with the ITD Exclusion Criteria: pediatric patients patients that do not present with or develop hypotension patients who the ITD will not form a secure seal due to anatomical abnormalities

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ResQGARD ITD<br>Subjects receive a ResQGARD ITD. | Device: ResQGARD ITD<br>* Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Blood Pressure From Baseline (Before ITD Use) | Determining whether the application of an ITD will provide improvement in systolic blood pressure in subjects with hypotension in patients being treated by San Antonio EMS when compared to baseline. | During device use, up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability | Determine patient tolerability of the device while breathing through it. This is subjectively measured by the paramedic administering the device based on verbal reporting from the patient and paramedic estimation of the patient response to the device. | Duration of device use, up to 1 hour |
Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients

Study Overview
=================
Brief Summary
-----------------
This is a prospective cohort study aimed to evaluate change of cardiovascular calcification after parathyroidectomy in patients with end-stage renal disease on dialysis compared with control group on conservative treatment.

Official Title
-----------------
Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients: a Prospective Cohort Study

Conditions
-----------------
Secondary Hyperparathyroidism, Chronic Kidney Disease Mineral and Bone Disorder, Vascular Calcification, Dialysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years ESRD patients receiving long-term hemodialysis or peritoneal dialysis treatment Severe secondary hyperparathyroidism defined as iPTH level > 800 pg/ml, followed with hypercalcemia and/or hyperphosphatemia; with presence of one or more nodular or diffuse parathyroid hyperplasia confirmed with CT Exclusion Criteria: 1. Primary hyperparathyroidosis as a cause of ESRD

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 |
| --- | --- |
| sPTx group<br>Patients underwent subtotal parathyroidectomy due to severe secondary hyperparathyroidism | |
| TPTx+AT group<br>Patients underwent total parathyroidectomy with immediate autotransplantation of parathyroid tissue due to severe secondary hyperparathyroidism | |
| Control group<br>Patients with severe SHPT on conservative treatment (calcimimetics, active vitamin D analogues, phosphate-binders) who are likely to undergo surgery in a period of 12 months | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in coronary artery calcium score measured with CT |  | 18 months | 
| Change in vascular calcification score measured with semi-quantitative (Kauppila) test |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart valve calcium score |  | 18 months | 
| Change in intact parathyroid hormone (iPTH) level |  | 18 months | 
| Change in serum calcium level |  | 18 months | 
| Change in serum phosphate level |  | 18weeks | 
| Change in alkaline phosphatase |  | 18 months | 
| Serious adverse events (cardiovascular events, death, fractures, emergency hospital admissions) during the follow-up period |  | 18 months |
Neuromodulation and Language Acquisition (Stage Ib)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether rivastigmine or pramipexol are effective in boosting semantic language acquisition in healthy subjects.

Detailed Description
-----------------
Our prior work shows that d-amphetamine and the dopamine precursor levodopa markedly improve word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind clinical trial, we probe whether a selective d2/d3 dopamine agonist (pramipexole) or cholinergic neuromodulation (rivastigmine), after a titration period of five days, will yield a learning enhancement comparable to using levodopa in healthy subjects. The expected scientific results will strengthen the basis for transferring neuromodulatory interventions from the laboratory to stroke patients with language dysfunctions.

Official Title
-----------------
Neuromodulation and Language Acquisition (KS-Neuromod_01, Stage Ib)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Pramipexole
* Drug: Rivastigmine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects 20-35 years old Right handedness Left language dominance (as assessed by functional transcranial Doppler ultrasonography [fTCD]) Exclusion Criteria: Neurological/psychiatric/metabolic/cardiac disorders Asthma Known allergic reactions to one of the experimental drugs Other drugs affecting the central nervous system Leisure drug ingestion during the past 4 weeks (urine test) Smoking cessation during the past 2 weeks > 6 cups of coffee or energy drinks per day > 10 cigarettes per day > 50 grams of alcohol per day

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pramipexole|nan|
|Drug: Rivastigmine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boost in language learning success (percent hits) through neuromodulation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability of language learning success after one week, one month, and one year |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
language acquisition, plasticity, stroke recovery, associative learning
Microbiome Changes in Travelers to Tropical Destinations

Study Overview
=================
Brief Summary
-----------------
The human gut contain a wide range of microorganisms creating the gut microbiome. The microbiome has great impact on metabolic and immunologic processes and responses. Travelers who travel to tropical destinations where the intestinal infection risk is high are prone to microbiome changes. During the current study the travelers will give feces specimen before and after the travel and their microbiome will be analyzed.

Detailed Description
-----------------
Individual differences in the microorganisms variety are affected by external factors such as food, age, geographic location, medication consumption, host genetics and exposure to microorganisms in early stages of life. During the current study the geographic location affect will be tested by comparing the microorganism environment before and after traveling to tropical destinations.

Official Title
-----------------
Microbiome Changes in Travelers to Tropical Destinations

Conditions
-----------------
Intestinal Diseases

Intervention / Treatment
-----------------
* Other: feces sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Travelers who intended to travel to tropical areas Good general health Exclusion Criteria: Medication consumption Background diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Research group<br>The study contain only one group: travelers who intended to travel to tropical destinations. The participants will give a feces sample before and after the travel. | Other: feces sample<br>* The travelers will give feces sample before and after the travel. The sample microorganisms will be analyzed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type and number of intestinal microorganisms | The participants microbiome will be analyzed before and after the travel. The type and number of microorganisms will be determined by microbiological measurements. | 1 year |
Regular Use Effect of Inhaled Ipratropium Bromide on Airway Responsiveness to Methacholine in Well-controlled Asthma

Study Overview
=================
Brief Summary
-----------------
Study is looking at the development of tolerance to methacholine following regular use of ipratropium bromide in mild asthmatics.

Detailed Description
-----------------
This study is being conducted people with well controlled (mild) asthma to determine if ipratropium bromide taken three times daily for six days (i.e. 2 puffs in the morning, 2 puffs in the afternoon and 2 puffs in the evening) followed by a final dose on the morning of day 7 reduces the effectiveness of this medication on blocking the effect of methacholine challenge.

Official Title
-----------------
Regular Use Effect of Inhaled Ipratropium Bromide on Airway Responsiveness to Methacholine in Well-controlled Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Ipratropium Metered Dose Inhaler
* Drug: placebo metered dose inhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: airway responsiveness to methacholine adequate baseline lung function no respiratory infection or exposure to stimuli that may alter response to methacholine within 4 weeks Exclusion Criteria: pregnancy current smoker requirement for medications other than salbutamol that will interfere with airway response to methacholine

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ipratropium bromide<br>20mcg bronchodilator inhaler | Drug: Ipratropium Metered Dose Inhaler<br>* MDI to deliver 20mcg per puff ipratropium bromide<br>|
| Placebo Comparator: placebo<br>matching bronchodilator inhaler | Drug: placebo metered dose inhaler<br>* matched MDI to deliver inactive drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methacholine PD20 | dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in one second) | Pre treatment | 
| Methacholine PD20 | dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in one second) | Day 7 after starting treatment | 
| Methacholine PD20 | dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in one second) | 24 hours after last dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ipratropium bromide, methacholine PD20, tolerance
Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET

Study Overview
=================
Brief Summary
-----------------
Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic stimulation (rTMS) was thus suggested in this indication.

Detailed Description
-----------------
We recently demonstrated that these patients exhibit significant perfusion abnormalities in regions of the brain known to be involved in sensory and affective-attentional dimensions of pain processing. These results, in agreement with previous functional magnetic resonance imaging reports, confirm the hypothesis of central sensitization, which provides the rationale for prescription of centrally acting analgesic agents in patients with severe FM.

Official Title
-----------------
Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Prospective Randomized Blinded Placebo-controlled Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Other: Transcranial stimulation
* Other: Transcranial stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female or male patient, aged from 18 to 65 years Patient presenting a primary fibromyalgia answering the criteria of the ACR At present painful patient with a digital echelle of the briefing inventory bread superior or equal to 4/10 Patient presenting a stable treatment since at least 1 less Exclusion Criteria: Patient minor pregnant woman women in age to procreate without contraception patient deprived of freedom further to a court or administrative order patient presenting a secondary fibromyalgia

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Sound placebo | Other: Transcranial stimulation<br>* Stimulation to white<br>|
| Experimental: 2<br>Sound | Other: Transcranial stimulation<br>* Repetitive transcranial magnetic stimulation (rTMS)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic efficiency |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional evaluation of the pain |  | 36 months | 
| Evaluation of the quality of life |  | 36 months | 
| Evaluation of the tolerance of the treatment |  | 36 months |
Clinical Validation of NAVOY® Acute Kidney Injury in Swedish ICU Patients

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate the performance of the prediction algorithm NAVOY® AKI in a Swedish adult ICU patient population versus fulfilment of KDIGO diagnostic criteria.

Official Title
-----------------
Clinical Validation of NAVOY® Acute Kidney Injury in Swedish ICU Patients

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study will only include the subjects from the SEP-SE-02 study population. (NCT04570618) Exclusion Criteria: None

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

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 |
| --- | --- | --- |
| Prediction performance of NAVOY® AKI | The sensitivity, specificity, and accuracy will be calculated comparing the algorithm's predictions with the true AKI outcome. | Data from ICU stay between December 2020 to October 2021. |
Plasma Cystatin C and Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
To evaluate the utility of plasma cystatin C(pCysC) as a predictive and diagnostic marker of acute kidney injury(AKI) in patients undergone cardiopulmonary bypass surgery.

Detailed Description
-----------------
This is a prospective AKI observational study in patients undergone cardiopulmonary bypass surgery. pCysC and plasma creatine will be measured at entry to ICU.AKI was defined as 50% increase in plasma creatine above baseline.The predictive and diagnostic performance of pCysC will be assessed from area under receiver operator characteristic curve(AUC) and odds ratio(OR).

Official Title
-----------------
Use of Cystatin C in Predicting AKI in Patients Undergone Cardiopulmonary Bypass Surgery

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with CPB and admitted to ICU Exclusion Criteria: patients with the age >80 or <18 years with preexisting renal dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| AKI group<br>patients with AKI after cardiopulmonary bypass surgery | |
| non-AKI group<br>patients without AKI during study period | |

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
-----------------
cystatin C,acute kidney injury,