linjc16/ctgov huggingface dataset:
ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gain additional safety information as well as to determine after the study drug has been given to patients who have undergone total hip replacement surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood clots in legs) or pulmonary embolism (blood clots in lungs).

Official Title
-----------------
ThromboEMbolism Prevention Efficacy and Safety Trial (TEMPEST): A Double-blind Four-week Study to Assess the Efficacy, Safety, and Tolerability of SB-424323 in the Extended Prophylaxis of Patients Following Total Hip Arthroplasty

Conditions
-----------------
Arthroplasty

Intervention / Treatment
-----------------
* Drug: SB-424323
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side). Patients who have given written informed consent to participate in this study. Exclusion Criteria: Patients with a contraindication to contrast venography Patients with an increased risk of bleeding. Patients with a predefined risk for prethrombotic episodes or a history of thrombophilia. Other inclusion or exclusion criteria to be determined by the physician and study sponsor.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB424323, 500 mg BID<br> | Drug: SB-424323<br>* 500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days<br>|
| Experimental: SB424323, 125 mg BID<br> | Drug: SB-424323<br>* 500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* matching placebo, oral, BID for 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VTE | Incidence of VTE during the 28-day treatment period, including death due to VTE | 28 day treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| types of VTE | The incidence of the types of VTE including, DVT (deep vein thrombosis), symptomatic VTE, PE] and anti-IIa activity | 28 day treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
venous thromboembolism, thromboembolism, pulmonary embolism, deep vein thrombosis
Study Comparing Piperacillin-tazobactam Versus Piperacillin-tazobactam Plus Glycopeptide in Neutropenic Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the efficacy and tolerance of piperacillin-tazobactam versus piperacillin-tazobactam plus glycopeptide as initial empiric antibiotic treatment for fever in neutropenic patients. Study of consecutive cohorts(2). First the patients will be included in the monotherapy branch until completing the predicted number of cases. When this happens, the Coordinating Center will communicate it to the participant centers and from then the patients will be included in the combined therapy.

Official Title
-----------------
Monotherapy With Piperacillin-tazobactam Versus Combination Therapy With Piperacillin-tazobactam Plus Glycopeptide as an Initial Empiric Therapy for Fever in Neutropenic Patients. An Observational Prospective Study.

Conditions
-----------------
Hematological Malignancy, Leukemia, Myelodysplasia, Lymphoma, Myeloma, Stem Cell Transplantation

Intervention / Treatment
-----------------
* Drug: piperacillin-tazobactam
* Drug: glycopeptide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hematological malignancy or those who had undergone stem cell transplantation for neoplastic disease. Fever (>38ºC) Neutropenia (absolute neutrophil count < 500 or < 1000 anticipated to fall below 500 cells within 24-48 hours). Exclusion Criteria: Known allergy to any of the antibiotics used in this trial A high probability of death within 48 hours

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 |
| --- |
|Drug: piperacillin-tazobactam|nan|
|Drug: glycopeptide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Clinical efficacy evaluation:72 and 96 hours after the initiation of empirical therapy (early evaluation) and at the completion of the therapeutic trial (overall valuation) |  | 3 months | 
| - Safety evaluation:during the empirical therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological evaluation:at the completion of the therapeutic trial (overall evaluation) |  | 3 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leukemia, Lymphoma, Myeloma
Energy Specific Far Infrared Radiation Treatment for Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
A preliminary study to determine the possibility of using far infrared (FIR) radiation to treat impotency.

Detailed Description
-----------------
Erectile dysfunction is characterized by the regular or repeated inability to obtain or maintain an erection. Erection depends on a complex interaction of psychological, neural, vascular and endocrine factors. We are proposing a non-drug and a non-invasive radiation treatment for the enhancement of erection.

Official Title
-----------------
Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Erectile Dysfunction.

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Radiation: Far Infrared Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons with erection challenges Exclusion Criteria: None
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Other: 1<br> | Radiation: Far Infrared Radiation<br>* Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes each session.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point is to determine the therapeutic effects of far infrared radiation on erectile dysfunction. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of far infrared radiation on other male conditions like prostate cancer |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Impotence, Male Impotence, Male Sexual Impotence
Parent Mentor Asthma Study

Study Overview
=================
Brief Summary
-----------------
Asthma disproportionately affects minorities, but few studies have evaluated interventions to improve asthma outcomes in minority children.The purpose of the study is to determine whether Parent Mentors (PMs) are more effective than traditional asthma care in reducing minority children's asthma morbidity, costs, and use of services, while increasing families' quality of life and parental self-efficacy.

Official Title
-----------------
Using Parent Mentors to Improve Asthma Care for Urban Minority Children

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

Intervention / Treatment
-----------------
* Behavioral: Using Parent Mentors to Improve Asthma Care for Urban Minority Children


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The child was 2-18 years old African-American or Latino race/ethnicity for the child (by parental identification) Primary residence in a Milwaukee zip code ED or inpatient ward admission with a primary diagnosis of asthma. Exclusion Criteria: Significant co-morbidity, including other pulmonary conditions, cardiac pathology, renal abnormalities, diabetes mellitus, epilepsy, and other co-morbidities that might lead to ED visits or hospitalizations, and current enrollment in a case management, intervention, or outreach program for childhood asthma management.

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Using Parent Mentors to Improve Asthma Care for Urban Minority Children|nan|

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
-----------------
Using Parent Mentors to Improve Asthma Care for Urban Minority Children
A Safety and Efficacy Study of SHR4640 and Febuxostat in Subjects With Hyperuricemia

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to assess the Safety and Efficacy of SHR4640 and Febuxostat in patients with Hyperuricemia.

Official Title
-----------------
A Phase II, MultiCenter, Double-Blind Study to Evaluate the Efficacy and Safety of SHR4640 and Febuxostat in Subjects With Hyperuricemia

Conditions
-----------------
Hyperuricemia

Intervention / Treatment
-----------------
* Drug: SHR4640 dose1 plus Febuxostat dose1
* Drug: SHR4640 dose1 plus Febuxostat dose2
* Drug: SHR4640 dose2 plus Febuxostat dose3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a body mass index ≥18 and ≤30 kg/m2; Screening sUA value ≥8mg/dl; Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values. Exclusion Criteria: Subject known or suspected of being sensitive to the study drugs or its ingredient； ALT、AST、TBIL>1.5ULN; History of kidney stones or screening kidney stones by B-ultrasound； History of malignancy； History of xanthinuria； Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood.

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: Treatment group A<br>SHR4640 dose1 Oral Tablet plus Febuxostat dose1 Oral Tablet Day1 Day28 qd. | Drug: SHR4640 dose1 plus Febuxostat dose1<br>* Tablet,dose1,QD<br>|
| Experimental: Treatment group B<br>SHR4640 dose1 Oral Tablet plus Febuxostat dose2 Oral Tablet Day1 Day28 qd. | Drug: SHR4640 dose1 plus Febuxostat dose2<br>* Tablet,dose1, dose2 QD<br>|
| Experimental: Treatment group C<br>SHR4640 dose2 Oral Tablet plus Febuxostat dose3 Oral Tablet Day1 Day28 qd. | Drug: SHR4640 dose2 plus Febuxostat dose3<br>* Tablet,dose2, dose3 QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events(AEs) and Serious Adverse Events(SAEs) | Incidence of AEs and SAEs, incidence of Treatment-Emergent Adverse Events, incidence of drug related adverse events (safety and tolerability) | Up to week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with a serum uric level≤360μmol/L |  | At week1, 2, 3 and 4 | 
| Percentage change from baseline in serum uric level . |  | At week1, 2, 3 and 4 | 
| Actual change from baseline in serum uric level |  | At week1, 2, 3 and 4 |
Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
This program is to provide expanded access to aztreonam lysine for inhalation (AZLI) prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P. aeruginosa airway infection who have limited treatment options and are at risk for disease progression.

Official Title
-----------------
Expanded Access for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression

Conditions
-----------------
Cystic Fibrosis, Pseudomonas Aeruginosa

Intervention / Treatment
-----------------
* Drug: Aztreonam lysine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 6 years of age Patient has CF as diagnosed by one of the following: Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test, or Two well characterized genetic mutations in the CFTR gene, or Abnormal nasal potential difference with accompanying symptoms characteristic of CF PA present in expectorated sputum or throat swab culture within 2 months prior to consent Patient must be able to provide written informed consent/assent prior to any study related procedure; parent/guardian must be able to give written informed consent as necessary prior to any study related procedure At high risk for disease progression as defined by one of the following patient populations: FEV1 ≤ 50 % predicted at the time of consent OR Completed participation in CP-AI-006 (through Visit 20). Patients who withdraw from CP-AI-006 prior to completing all courses of AZLI and all study visits will not be eligible for this protocol. Exclusion Criteria: Patients with any serious or active medical or psychiatric illness that, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol or dosing requirements Patients with hypersensitivity to any of the components of the drug product Currently enrolled in another clinical trial Pregnant or lactating females

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aztreonam lysine|Open-label, expanded access for Aztreonam lysine for inhalation 75 mg three times daily|

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
-----------------
CF, Cystic fibrosis, Pseudomonas aeruginosa, EAP, Expanded access, AZLI, Aztreonam lysine
Analgesia in ÖAMTC Helicopter Emergency Service in Austria

Study Overview
=================
Brief Summary
-----------------
A sufficient analgesia in injured or sick people is the main goal of physicians treating a patient. In emergency medicine potent analgesia like ketamine or opioids are routinely used. It is unknown if there are any severe side effects or if the use is safe while in use in a Helicopter Emergency Service equipped with emergency physicians.

Official Title
-----------------
Analgesia in ÖAMTC Helicopter Emergency Service in Austria: A Retrospective Analysis

Conditions
-----------------
Field Physician Care, Analgesics, Hypnotics, Emergencies, Safety, Accident, Trauma, Multiple, Pain, Acute

Intervention / Treatment
-----------------
* Other: analgesics
* Other: hypnotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Analgesia or use of hypnotics in ÖAMTC Air Ambulance Service in Austria 2000-2016 Exclusion Criteria: No analgesia, or analgesia use not in connection to ÖAMTC Air Ambulance Service. Analgesia given not in the period of examination (2000-2016)
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 |
| --- | --- |
| Patient given analgesics or hypnotics<br>All patients treated with any kind of analgesics or hypnotics are analyzed and compared. | Other: analgesics<br>* analgesics given to a patient treated from HEMS<br>Other: hypnotics<br>* hypnotics given to a patient treated from HEMS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful analgesia | Change in reported pain severity before and after treatment with analgesic. (Numeric Rating Scale, NRS, eleven-point scale reporting no pain=0, to maximum pain=10; 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain) | 2000-2016 | 
| Analgesic, drug type | Use of analgesic (n= type of analgesic) | 2000-2016 | 
| Analgesic, frequency | Use of analgesic (n= frequency how often analgesic is used) | 2000-2016 | 
| Analgesic, amount of analgesics | Use of analgesic (n= amount of analgesic used in mg or µg) | 2000-2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | Type of side effect (respiratory arrest after use, hypoxemia, desaturation (SpO2<90%), dead) | 2000-2016 | 
| Frequency of side effects | Frequency of side effects (frequency of side effect/n=total number of analgesic use; very common>=1/10, common>=1/100 and<1/10, uncommon >=1/1000 and <1/100, rare >=1/10000 and <1/1000, very rare <1/10000) | 2000-2016 | 
| Severity of side effect | severity of side effect (0=none, 1=mild, 2=moderate, 3=severe, 4=potentially life threatening) | 2000-2016 |
Qualitative Assessment of the Impact of TTNS on QOL and Participation

Study Overview
=================
Brief Summary
-----------------
This study through the use of semi-structured interviews or focus groups will explore the lived experience with Transcutaneous Tibial Nerve Stimulation (TTNS) with Neurogenic Lower Urinary Tract Dysfunction to generate user-defined themes regarding bladder function and catheter-related barriers and the daily impacts on one's life.

Detailed Description
-----------------
Identify NLUTD user-defined themes regarding bladder function and and the daily impacts on one's life Specific Aim: Using iterative, semi-structured interviews or focus groups to explore the lived experience using TTNS neuromodulation to generate user-defined themes regarding bladder function and the daily impacts on one's life.

Official Title
-----------------
Qualitative Assessment of the Impact of Transcutaneous Tibial Nerve Stimulation (TTNS) on Quality of Life and Participation

Conditions
-----------------
Neurogenic Bladder, Urinary Retention, Urinary Tract Infections, Spinal Cord Injuries

Intervention / Treatment
-----------------
* Behavioral: Semi-structured interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Participated in TTNS Study for 1 year.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Subjects who used TTNS<br>Subjects will have Neurogenic Lower Urinary Tract Dysfunction and will have participated in a study with TTNS. n=20 | Behavioral: Semi-structured interview<br>* Using iterative, semi-structured interviews or focus groups to explore the lived experience with CC and usual customary care (UCC) of catheter users with NLUTD and their caretakers to generate user-defined themes regarding bladder function and catheter-related barriers and the daily impacts on one's life.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumer user-defined themes from qualitative interviews | Explore the lived experience using the transcutaneous tibial nerve stimulation to generate user-defined themes regarding bladder function and the daily impacts on one's life. Qualitative analysis will be used to define these themes about how TTNS impacted ones life, and bladder function | Collected once at study completion at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up calls regarding user-defined themes | Possible follow-up calls for clarification on user-defined themes (primary outcome) may need to be done to | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, Participation, Barrier