linjc16/ctgov huggingface dataset:
Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Study to assess safety and tolerability of a single dose of study-drug administered to Cystic Fibrosis (CF) patients.

Official Title
-----------------
A Double Blind, Randomized, Placebo Controlled, Single Dose, Phase I Study of the Safety and Tolerability of Alpha1 Proteinase Inhibitor (Human) Inhalation Solution (CR002) in Subjects With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Biological: CR002 Liquid API
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a confirmed diagnosis of CF: one or more clinical findings consistent with CF and at least one of the following: Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR A genotype with two identifiable mutations consistent with CF (∆F508 homozygous or two alleles known to cause a class I, II, or III mutation) Have an FEV1 ≥30% of predicted normal as defined by age, gender, and height Exclusion Criteria: Oxygen saturation <90% Changed in treatment regimen within 2 weeks prior to screening Antibiotics regimen change < 4 weeks before screening Persistent colonization with Burkholderia cepacia Serum IgA < 50% of lower level of normal

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 |
| --- | --- |
| Experimental: Liquid API<br> | Biological: CR002 Liquid API<br>* A single nominal dose of CR002 (three different dose groups) will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.<br>|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* A single nominal dose of Placebo will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Adverse events |  | 44 Days (Day -21 to Day 22) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystic Fibrosis
Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Astragalus Membranaceus in the Patients After Stroke With Fatigue

Study Overview
=================
Brief Summary
-----------------
The high levels of fatigue in stroke patients without neurological impairment suggest it has a central origin rather than being the result of increased physical effort required after stroke（Winward et al., 2009）. Fatigue is different from post-stroke depression and the more serious stroke patients are more prone to fatigue（Windward et al., 2009）. Fatigue is one of the symptoms of qi deficiency,and Astragalus membranaceus is the most effective of all traditional Chinese medicine and can tonifying middle and tonify the original qi. Therefore, the aim of this study was to investigate the efficacy of Astragalus membranaceus on post-stroke fatigue.

Conditions
-----------------
Fatigue, Stroke

Intervention / Treatment
-----------------
* Drug: Chinese Herb Astragalus membranaceus
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gender: Male or female. Age: between 40 and 80 years old. Three months after stroke. Hemorrhagic stroke or ischemic stroke. Fatigue score from screen process ≧4. Subject with comprehension or communication. Volunteer signs the agreement to participate the study after whole study purpose and procedures description in detail. Exclusion Criteria: People from mental illness can not to participate the evaluation. Major diseases such as cancer、Chronic pulmonary obstructive disease(COPD)、 Heart failure、Myocardial Infraction、Chronic renal failure or Liver cirrhosis. Pregnant woman. Breast-feeding woman.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese Herb Astragalus membranaceus<br> | Drug: Chinese Herb Astragalus membranaceus<br>* Astragalus membranaceus(AM)at a rate of 2.8g three times per day<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* at a rate of 2.8g three times per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC QLQ-C30 |  | 2 year(all patients) | 
| BFI-T score |  | 2 years(all patients) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 score |  | 2 years(all patients) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
After stroke with fatigue
Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized controlled trial of all patients undergoing femoral revision at Thomas Jefferson University Hospital and Rothman Institute undergoing femoral revision surgery with the use of a modern titanium, fluted, tapered stem. At the time of surgery, patients will be randomized to six weeks of toe-touch weight bearing or immediate weight bearing as tolerated

Official Title
-----------------
Randomized Controlled Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems

Conditions
-----------------
Postoperative Pain, Hip Arthroplasty

Intervention / Treatment
-----------------
* Procedure: immediate weight bearing after surgery
* Procedure: 6 weeks of toe-touch weight bearing after surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: femoral revision patients with the use of a modern titanium, fluted, tapered stem. Exclusion Criteria: include cemented fixation of the stem and patients with a tenuous acetabular reconstruction for whom the surgeon would like to protect weight bearing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1: immediate weight bearing<br> | Procedure: immediate weight bearing after surgery<br>* immediate weight bearing<br>|
| Other: Group 2: 6 week toe touch weight bearing<br> | Procedure: 6 weeks of toe-touch weight bearing after surgery<br>* 6 weeks of toe-touch weight bearing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to function | time to return to baseline ambulatory status | 1 year | 
| Postoperative Complications | radiographic measurements of subsidence of the stem | 1 year | 
| Implant survival | re-revision rates within one year | 1 year |
The Impact of Obesity on Children and Adolescents.

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the association of obesity with arterial blood pressure, atherosclerosis, target organ damage (heart, arteries, kidney) and insulin resistance in children and young adolescents.

Official Title
-----------------
The Relation of Obesity With Metabolic Disorders, Inflammation Markers and Arterial Blood Pressure With Preclinical Target-organ Damage in Children and Young Adolescents.

Conditions
-----------------
Obesity, Cardiovascular Risk Factors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overweight (85th<BMI<95th percentile) and obese (BMI>=95th percentile) children and adolescents No medication treatment (apart from bronchodilators, T4 in euthyroid children) No severe mental problem Parents' and patients' signed consent Exclusion Criteria: Severe chronic or acute cardiac disease or other severe chronic or acute disease Any acute inflammation Familial dyslipidemia Clinical hypothyroidism or other endocrinopathy Poor compliance.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum 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 |
| --- | --- | --- |
| Blood Pressure levels, Target organ damage (Left Ventricular Hypertrophy, IMT, pulse wave velocity, microalbuminuria), Insulin Resistance |  | 3 weeks |
Study of Hypoxia Measured in F-Miso PET/Scan and MRI in Patients With Squamous Cells Carcinoma

Study Overview
=================
Brief Summary
-----------------
Hypoxia imaging has not been studied extensively by combining PET and MRI data. Few studies performed the double imaging and none associated anatomopathology with it . This study will use a rigorous methodology through the production of PET/MRI images at the same time by transferring the patient directly from PET to MRI. In addition, the population, unlike other studies, will include preoperative patients with 24-hour surgery for hypoxia imaging by obtaining additional data through specific immunohistochemical analysis of hypoxia.

Official Title
-----------------
Comparative Study of Hypoxia Measured in F-Miso PET/Scan and MRI in Patients With Squamous Cells Carcinoma : Correlation With Immunohistochemistry

Conditions
-----------------
Squamous Cell Carcinoma of the Oropharynx

Intervention / Treatment
-----------------
* Drug: F-Miso PET scan coupled with MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with squamous cells carcinoma of oropharynx Age Superior to 10 years old Male or Female measurable target according RECIST criteria Exclusion Criteria: -Other histologic cancer than squamous cells carcinoma of oropharynx No measurable target Presence of metastasis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Measure of hypoxia by F-Miso PET scan and RMI<br>Patient will undergo F-Miso PET scan and MRI to detect hypoxia. Imaging will be correlated with immunohistochemistry on tumour biopsy | Drug: F-Miso PET scan coupled with MRI<br>* Patient will undergo F-Miso PET and MRI before surgery for their head and neck cancer. Hypoxia detect with imaging will be correlated with hypoxia detected by immunohistochemistry on tumour biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of biodistribution of F-Miso PET scan in pre-therapeutic and sequences of MRI in patient with squamous cells carcinoma of oropharynx |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of F-Miso PET scan and Magnetic resonance imaging to measure hypoxia |  | 1 year | 
| Correlation between recurrence free survival at one year and rate of hypoxia determined by the 3 techniques (PET scan, MRI and IHC) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
F-Miso PET scan, Magnetic resonance imaging, immunohistochemistry, Head and neck cancer
A Study of Ganfort Versus Duotrav in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
This is a single-center, cross-over comparison parallel group randomized trial designed to evaluate the efficacy and safety of Ganfort compared to Duotrav for a treatment period of 8 weeks each.

Official Title
-----------------
A Randomized, Comparison of the Effects of Ganfort and Duotrav on Intraocular Pressure in Patients With Primary Open Angle Glaucoma or Ocular Hypertension Open Label/Evaluator-blind/Cross-over Study

Conditions
-----------------
Ocular Hypertension, Primary Open Angle Glaucoma

Intervention / Treatment
-----------------
* Drug: Ganfort
* Drug: Duotrav


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Visual acuity 6/60 or better Patients who are controlled (IOP < 21 mmHg) on non-fixed combination of Latanoprost & Timolol for at least 3 months before the baseline visit and Patients on mono-therapy either Latanoprost or Timolol who are eligible for dual therapy being not satisfactorily controlled (IOP>21mmHG) Exclusion Criteria: Angle closure glaucoma Neovascular Galucoma Secondary open angle glaucoma Ocular infection/inflammation within 3 months Ocular surgery within 3 months History of Refractive surgery Argon laser trabeculoplasty/Selective laser trabeculoplasty Pregnancy/nursing Hypersensitivity to benzalkonium chloride or to any other components of the trial drugs solution. Patients in whom beta-blockers are contraindicated Patients on any drugs known to affect IOP.
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ganfort<br>Fixed combination of Bimatoprost and Timolol | Drug: Ganfort<br>* Fixed combination of Bimatoprost and Timolol (BTFC; Ganfort (300 microgram + 5 mg/ml eyedrops solution)<br>|
| Active Comparator: Duotrav<br>Fixed combination of Travoprost and Timolol | Drug: Duotrav<br>* Fixed combination of Travoprost and Timolol (TTFC; Duotrav (40 micrograms + 5 mg/ml eyedrops solution)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean intraocular pressure of the 12-hour IOP curve | To compare the mean intraocular pressure of the 12-hour IOP curve for Ganfort and Duotrav | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean intraocular pressure | Difference in mean IOP for Ganfort and Duotrav | 12 hours |
Estimation of the Localization Accuracy of the Genicular Ablation Procedure Applied for Chronic Pain Suppression

Study Overview
=================
Brief Summary
-----------------
Estimation of the localization accuracy of the genicular ablation procedure applied for chronic pain suppression

Official Title
-----------------
Estimation of the Localization Accuracy of the Genicular Ablation Procedure Applied for Chronic Pain Suppression

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Device: MRI
* Procedure: genicular ablation procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years and older. Diagnosed with primary degenerative osteoarthritis. Complaining of knee pains Patients clinically eligible for genicular nerve ablation procedure non-electively based on physical examination Patient signed ICF Exclusion Criteria: Co-morbidities: patient suffers from neuropathy, bony tumors, traumatic fractures and DM. Claustrophobic or failing cooperativity assessment of laying still during long MRI scans Pregnancy or pregnancy suspicion Enrolled in concurrent studies that may confound the results of this study Clinical condition that in the investigator's opinion would not allow the subject to complete the study, e.g., tremor, extreme obesity, mental disorders.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI scanning and the genicular ablation<br>patients undergoing both MRI scanning and the genicular ablation procedure. additional MRI testing of apprx. 0.5-1 hour | Device: MRI<br>* patients will undergo an additional MRI testing of apprx. 0.5-1 hour.<br>Procedure: genicular ablation procedure<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Location and orientation of the relevant genicular nerves based on eye-balling inspection of MRI images by a radiologist |  | 6 months |
Biomarkers in Tissue Samples From Patients With Ductal Breast Carcinoma in Situ

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in tissue samples from patients with ductal breast carcinoma in situ.

Detailed Description
-----------------
OBJECTIVES: To validate the prognostic utility of a new ductal breast carcinoma in situ (DCIS) genomic score and the Oncotype DX Recurrence Score® assay in tissue samples from patients with DCIS enrolled on clinical trial ECOG-E5194. OUTLINE: RNA extracted from archived tissue samples are analyzed for gene expression profile by Oncotype DX Recurrence Score® assay (a reverse transcriptase-PCR-based assay).

Official Title
-----------------
A Correlative Science Study for ECOG E5194

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Genetic: RNA analysis
* Genetic: gene expression analysis
* Genetic: reverse transcriptase-polymerase chain reaction
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of ductal breast carcinoma in situ Enrolled on clinical trial ECOG-E5194 Local surgery without radiotherapy Treated or not treated with tamoxifen Available tissue samples Hormone receptor status not specified PATIENT CHARACTERISTICS: Menopausal status not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: RNA analysis|nan|
|Genetic: gene expression analysis|nan|
|Genetic: reverse transcriptase-polymerase chain reaction|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ipsilateral local failure (first event of invasive or DCIS recurrence) |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contralateral breast cancer (invasive or DCIS) |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ductal breast carcinoma in situ
Static Magnetic Therapy for Carpal Tunnel Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to investigate if magnet therapy is effective as an alternative therapy for CTS.

Official Title
-----------------
A Double Blinded, Prospective, Randomized Trial of Static Magnetic Therapy for Carpal Tunnel Syndrome (CTS)

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Device: Strong Magnetic Wristband
* Device: Weaker Magnetic Wristband


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of mild to moderate Carpal Tunnel Syndrome by history, clinical exam and Electromyography (EMG) study. ≥ 18 years Exclusion Criteria: Current use of magnets as therapy for Carpal Tunnel Syndrome Known allergy to silicone Unwillingness to wear wristband for 6 weeks Patients who have devices that may be affected by exposure to magnets such as vagal nerve stimulator, pacemaker or insulin pump.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Strong Magnetic Wristband<br>Magnetic wristband of 1,795 Gauss strength | Device: Strong Magnetic Wristband<br> <br> |
| Placebo Comparator: Weaker Magnetic Wristband<br>Magnetic wristband of 5 Gauss strength. | Device: Weaker Magnetic Wristband<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks | Patient reported outcome measure of symptom severity and functional status. Is made of the Symptom severity scale (11 items) score 1 to 5 where lower numbers denotes better outcomes; and the Functional status scale (8 items) score 1 to 5 where lower numbers denotes better outcomes. Total score 1- 95 where lower numbers denotes better outcomes. | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks | Ultrasound to assess the anatomy of the median nerve | Baseline and 6 weeks | 
| Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks | Ultrasound to assess the anatomy of the median nerve | Baseline and 6 weeks | 
| Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks | Ultrasound to assess the anatomy of the median nerve | Baseline and 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carpal Tunnel Syndrome