linjc16/ctgov huggingface dataset:
Positron-Emission Tomography With Vesicular Monoamine Transporter Ligand ([18F]-DTBZ) In Healthy Elderly And Young Subjects

Study Overview
=================
Brief Summary
-----------------
A total 25 healthy subjects will be included in this study. Subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.

Detailed Description
-----------------
The primary objective of this protocol is to assess the possible age-dependent decline in striatal 18F-DTBZ uptake of healthy subjects. This study is expected to be completed in a period of 2 years.

Official Title
-----------------
Positron-Emission Tomography With Vesicular Monoamine Transporter Ligand ([18F]-DTBZ) In Healthy Elderly And Young Subjects

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

Intervention / Treatment
-----------------
* Drug: 18F-DTBZ AV-133


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female age 20 years to 80 years. Subjects without significant neuropsychiatric disorder after evaluation by Neurologist. Subjects who provide a written informed consent prior to study entry. If the subject is incapable of informed consent, the caregiver may consent on behalf of the subject (the subject must still confirm assent). Exclusion Criteria: Pregnancy and breast feeding. Significant recent (within 6 months) history of neurological (including stroke and brain trauma) or psychiatric disorder. Alcohol or substance abuse within last year. Parkinson's disease or other brain degenerative disease (spinocerebellar ataxia, Wilson's disease, hydrocephalus, multiple infarction, history of severe head injury or intracranial operation. Unable to stay still in the MRI or PET scanner for 30 minutes.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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: 18F-DTBZ AV-133<br>18F-DTBZ AV-133 imaging | Drug: 18F-DTBZ AV-133<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age-Dependent Change in Striatal 18F-DTBZ Uptake of Healthy Subjects. |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Test/Retest 18F-DTBZ PET Measurements of VMAT2 Binding in Healthy Subjects. |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
18F-DTBZ AV-133 imaging
A New Etiological Cause for Anterior Cruciate Ligament Injury: E-Scooter

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to find the relationship between e-scooter use and anterior cruciate ligament injury.

Detailed Description
-----------------
The incidence of injuries related to e-scooter use is increasing. There is no study in the literature investigating the relationship between anterior cruciate ligament injury and e-scooter use.

Official Title
-----------------
A New Etiological Cause for Anterior Cruciate Ligament Injury: E-Scooter

Conditions
-----------------
Anterior Cruciate Ligament Tear

Intervention / Treatment
-----------------
* Other: Retrospective Data Review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with e-scooter related ACL injury Exclusion Criteria: Participants with other ACL injury etiology

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ACL injuries with e-scooter trauma<br> | Other: Retrospective Data Review<br>* Retrospective Data Review<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective Evaluation | The investigators evaluated medical report of ACL injuried patients retrospectively | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anterior Cruciate Ligament injuries, e-scooter
The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor

Study Overview
=================
Brief Summary
-----------------
To use the shear-wave elastography to assist the transthoracic ultrasound-guided aspiration biopsy of peripheral lung tumor To identify the intra-tumor heterogeneity of elasticity To increase the diagnostic yield in ultrasound-guided transthoracic biopsy of subpleural pulmonary tumor

Official Title
-----------------
The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor: a Randomized Controlled Trial

Conditions
-----------------
Lung Tumor

Intervention / Treatment
-----------------
* Procedure: different types of ultrasound technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: (1) Patients with radiographic evidence of pulmonary lesions Exclusion criteria: Age < 20 y/o Patients who cannot hold their breath for 5 seconds Inadequate shear-wave propagation of lung tumor

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shear-wave elastography-guided<br>Shear-wave elastography-guided bipsy | Procedure: different types of ultrasound technique<br>* Shear-wave elastography-guided or Convention ultrasound-guided<br>|
| Active Comparator: Convention ultrasound-guided<br>Convention ultrasound-guided biopsy | Procedure: different types of ultrasound technique<br>* Shear-wave elastography-guided or Convention ultrasound-guided<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic yield between two groups | sensitivity, specificity, positive predictive value, and negative predictive value | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total times of the biopsy | Total times of the biopsy | 1 day | 
| Procedure duration | Time duration | 1 day | 
| Complication rate | Complications like pneumothorax or hemothorax | 1 day |
A Long-term Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate of the long-term safety and efficacy of KCT-0809 in dry eye patients with Sjögren's syndrome.

Conditions
-----------------
Dry Eye With Sjögren's Syndrome

Intervention / Treatment
-----------------
* Drug: KCT-0809 ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dry eye patients with Sjögren's syndrome Corneal and conjunctival damage Exclusion Criteria: Severe ophthalmic disorder Punctal plugs or surgery for occlusion of the lacrimal puncta

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KCT-0809<br> | Drug: KCT-0809 ophthalmic solution<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of adverse events |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of the corneal staining |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye syndromes, Corneal diseases, Conjunctival diseases
Carotid Duplex Ultrasound for Selecting Patients for Endovascular Thrombectomy in Acute Stroke Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to address the usefulness of carotid duplex ultrasound as vascular imaging for selecting acute stroke patients for endovascular thrombectomy.

Official Title
-----------------
Emergent Carotid Ultrasound in Hyperacute Cerebral Vessel Occlusion for Selecting Patients to be Treated With Endovascular Clot Retrieval Treatment

Conditions
-----------------
Stroke, Acute

Intervention / Treatment
-----------------
* Procedure: After detection of occluded vessels by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Endovascular treatment can be initiated within 6 hours of symptom onset. ASPECTS of >=6 is diagnosed by two or more stroke physicians. The end diastolic velocity in the common carotid arteries or internal carotid artery is evaluated by carotid duplex ultrasound NIHSS score of >=6. Age>=18 years. Written informed consent is obtained. Exclusion Criteria: Pre-stroke modified Rankin Scale (mRS) score >=2. Difficulties to evaluate ASPECTS on initial CT. Difficulties to groin puncture. History of severe allergic reaction to contrast medium. End stage renal disease.

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: carotid duplex ultrasound<br>Single arm study. After detection of occluded vessels by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment. | Procedure: After detection of occluded vessels by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment.<br>* When the ratio of the end diastolic velocity in the common carotid arteries is greater than 1.4 or the diastolic flow in the internal carotid artery is not detected by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment. If vessel occlusion is not detected by carotid duplex ultrasound, additional vascular imaging including MR angiography or CT angiography is considered.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Scale |  | at 90 days after onset |
Tissue Bank of Biological Specimens From Patients With Gynecologic Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a tissue bank of gynecologic cancers and normal tissue for the study of cancer in order to better understand the changes occurring on a molecular level (DNA, RNA, protein) that lead to the development of cancer.

Detailed Description
-----------------
Cancer arises due to genetic alterations that disrupt numerous cellular functions including proliferation, programmed cell death and senescence, that ultimately control the number of cells in a population. The genetic damage that underlies the development of cancers has a diverse etiology and loss of DNA repair mechanisms also may play a role in allowing mutations to accumulate. Cancers are also characterized by the ability to invade surrounding tissues and to metastasize. Many of the molecular alterations involved in this process have yet to be elucidated. Gynecologic cancers afflict women of all ages. Cervical cancer is the most common gynecologic malignancy worldwide, accounting for over 400,000 cases annually. Endometrial cancer is the most common gynecologic malignancy with approximately 33,000 new cases being diagnosed annually in American women. Ovarian cancer is the fourth most common cause of cancer related mortality in American women, with approximately 14,000 deaths occurring from it in 2000. The creation of a tissue repository containing tissue specimens, blood/serum, and molecular extracts (DNA, RNA, protein) will provide a rich source of tissue for future gynecological disease research studies.

Official Title
-----------------
Tissue and Data Acquisition Activity for the Study of Gynecological Disease

Conditions
-----------------
Endometrial Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms, Leiomyoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled to undergo surgery for diagnosis and treatment of a gynecologic disease at one of the participating institutions > = 18 years old Ability to read English Exclusion Criteria: < 18 years old

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DNA, Tissue Bank, Endometrial neoplasm, uterine cervical neoplasm, ovarian neoplasm, leiomyoma, RNA, Protein, Serum
Open-Label Treatment Extension of Protocol MNTX 301

Study Overview
=================
Brief Summary
-----------------
This study is an open-label extension allowing patients who have completed Protocol MNTX 301 to continue to receive SC MNTX.

Official Title
-----------------
A Three-Month Open-Label Treatment Extension of Protocol MNTX 301

Conditions
-----------------
Terminal Illness

Intervention / Treatment
-----------------
* Drug: SC Methylnaltrexone (MNTX)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of protocol MNTX 301; Double-Blind Treatment and Open-Label Treatment Negative pregnancy test Exclusion Criteria: Women who are pregnant and/or nursing Any concurrent experimental drug therapy Evidence of fecal impaction Clinically significant active diverticular disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: SC Methylnaltrexone (MNTX)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events | To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pain scores | To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301. | 3 months | 
| Number of patients with opioid withdrawal symptoms | To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced medical illness
Comparison of Measurement of Arterial Blood Pressure by L&T NIBP Module With Invasive Arterial Blood Pressure in Neonates

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare Measurements of Arterial Blood Pressure by L&T NIBP Module With Invasive Arterial Blood Pressure in Neonates.

Official Title
-----------------
Comparison of Measurement of Arterial Blood Pressure by L&T NIBP Module With Invasive Arterial Blood Pressure in Neonates

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates admitted to NICU in whom arterial catheterization (radial or umbilical) was clinically indicated for a purpose other than for the comparative study. Exclusion Criteria: All neonates in whom arterial catheterization was not clinically indicated. If minimum of 5-paired measurements is not obtained either due to technical or clinical reason.

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 30 Days

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

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

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
-----------------
Non-Invasive Blood Pressure(NIBP)
Exercise and Nerve Function in Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the effect of a 10-week exercise program on nerve function and number of nerve fibers in the skin in the lower leg in people with diabetic neuropathy.

Detailed Description
-----------------
The objective for this application is to quantify the benefits of exercise on nerve function including proprioception, and investigate the relationship of these findings with improvements in epidermal and dermal innervation. In this pilot project, we will pursue 2 specific aims: 1) determine the effect of an exercise intervention on nerve function in people with diabetic neuropathy, and 2) assess changes in cutaneous innervation following participation in an exercise program.

Official Title
-----------------
Effectiveness of an Exercise Program on Nerve Function and Cutaneous Nerve Fibers in Adults With Type 2 Diabetes

Conditions
-----------------
Diabetic Neuropathy

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 40-70 Type 2 diabetes Peripheral neuropathy Exclusion Criteria: Serious cardiac history or other medical problems that would prevent safe participation in exercise

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise program<br>Supervised moderately-intense exercise, including both aerobic and strengthening activities. Sessions are 3-4 days per week for 10 weeks. | Behavioral: Exercise<br>* Supervised moderately-intense exercise, including both aerobic and strengthening activities. Sessions are 3-4 days per week for 10 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative sensory testing |  | 10 weeks | 
| Nerve conduction studies |  | 10 weeks | 
| Proprioception |  | 10 weeks | 
| Dermal and epidermal nerve fiber densities |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessments of neuropathy, pain, body mass index, muscle strength, and glycemic control (glycosylated hemoglobin or A1C) |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuropathy, diabetes
Rapid Diagnostic Testing and Artemisinin-Based Combination Therapy for Uncomplicated Malaria by Community Health Workers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficiency of a rapid diagnostic test (Paracheck Pf) for the diagnosis of uncomplicated Plasmodium falciparum malaria by community health workers at village level in Tanzania and how the use of rapid diagnostic test may influence prescription of antimalarial drugs. The hypothesis is that rapid diagnostic tests used by community health workers will reduce the use of antimalarial drugs (Coartem; Novartis) by 30% without affecting the health outcome.

Official Title
-----------------
Rapid Diagnostic Testing and Artemisinin-Based Combination Therapy for Uncomplicated Malaria by Community Health Workers

Conditions
-----------------
Uncomplicated Plasmodium Falciparum Malaria

Intervention / Treatment
-----------------
* Device: Rapid diagnostic test for malaria


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fever Informed consent Exclusion Criteria: Severe clinical manifestations, which require immediate referral Pregnancy Previous enrollment in the study within the last 28 days
Sexes Eligible for Study
-----------------
All

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

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: 1<br>Malaria diagnosis aided with rapid diagnostic test | Device: Rapid diagnostic test for malaria<br>* We used Paracheck Pf® (Orchid Biomedical Systems, India) as rapid diagnostic test in this trial<br>|
| Active Comparator: 2<br>Malaria diagnosis based on clinical judgement only | Device: Rapid diagnostic test for malaria<br>* We used Paracheck Pf® (Orchid Biomedical Systems, India) as rapid diagnostic test in this trial<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups |  | 28 days |