linjc16/ctgov huggingface dataset:
Study to Assess Safety, Tolerability and PK of AZD1480 in Patients With Solid Tumours

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to assess the safety, tolerability and PK of AZD1480 in patients with advanced solid malignancies.

Official Title
-----------------
A Phase I, Open-Label, Multi-Center, Dose-Escalation Study to Assess the Safety and Tolerability, and Pharmacokinetics of AZD1480 Administered as Daily Oral Monotherapy in Patients With Advanced Solid Malignancies in the Escalation Phase and EGFR or ROS Mutant NSCLC or Non-Smokers With Lung Metastasis in the Expansion Phase.

Conditions
-----------------
Solid Malignancies

Intervention / Treatment
-----------------
* Drug: AZD1480


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with advanced solid cancer without available therapy in the escalation phase and mutation positive NSCLC or non-smokers with other primary tumors lung metastasis in the expansion phase ECOG Performance Status 0-1 Evidence of post-menopausal status in females or males willing to use barrier contraception Exclusion Criteria: Prior therapy with any JAK2 medications Significant lung disorder or lung disease. Previous radiation therapy to chest wall or chest infection requiring antibiotic treatment within 21 days before study screening. Evidence of significant pulmonary hypertension or COPD Eye disease of the cornea

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: 1<br>AZD1480 until Maximum Tolerated Dose (MTD) is reached | Drug: AZD1480<br>* continuous daily oral capsule<br>|
| Experimental: 2<br>AZD1480 dose expansion of MTD | Drug: AZD1480<br>* continuous daily oral capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as assessed by Adverse events, vital signs, ECGs, Pulmonary Function Tests (DLco, FEV, FVC, Oxygen saturation) and laboratory data (chemistry, hematology and Urinalysis) |  | Information will be collected from the time the informed consent is signed, throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the pharmacokinetics of AZD1480 |  | During all cycles | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Jak2, cancer, jak 1, stat 3, Phase 1
Efficacy and Safety Study of Neramexane to Treat Congenital and Acquired Nystagmus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN) in comparison to placebo. In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included; this subgroup will be analyzed in an exploratory manner only.

Official Title
-----------------
Efficacy and Safety of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus: a Randomized, Double-blind, Placebo-controlled, Single Center, Proof of Concept Study Using a Two-period Cross-over Design

Conditions
-----------------
Nystagmus, Congenital Idiopathic, Nystagmus, Acquired

Intervention / Treatment
-----------------
* Drug: Neramexane mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with congenital idiopathic nystagmus or acquired nystagmus subsequent to multiple sclerosis male or female outpatients aged between 18 and 80 years (inclusive) at screening Exclusion Criteria: patients with evidence of neurologic disorders other than CIN such as congenital nystagmus due to albinism or retinal diseases and/or acquired nystagmus (exemption: secondary to MS)

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: Neramexane mesylate<br>* 2 double-blind, cross-over treatment periods of 7 weeks separated by a wash-out phase, up to 75 mg Neramexane mesylate per day<br>* Other names: - placebo, verum;|
| Other: 2<br> | Drug: Neramexane mesylate<br>* 2 double-blind, cross-over treatment periods of 7 weeks separated by a wash-out phase, up to 75 mg Neramexane mesylate per day<br>* Other names: - placebo, verum;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | Screening, Baseline, Week 3, 7, 11, 14, 18, and Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter |  |  |
Glucose Control in Open Heart Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to seek if there is difference to state glucose level in 80-120mg/dl or 200mg/dl in patients submitted to open heart surgery

Detailed Description
-----------------
Hyperglycaemia in the intensive care unit and perioperative period has been accused to be one of the causes of worse clinical outcome. It is known that in open heart surgeries the glucose level must be set less than 200mg/dl, but new trials had set the glucose level lower than that: 140mg/dl in some studies and even lower (80-110mg/dl). Our trial had the intention to seek if there is difference setting glucose level in 2 different ones would modifies clinical outcome.

Official Title
-----------------
Intensive Glucose Control Versus Conventional:Tendency Of Better Clinical Outcome In Open Heart Surgery

Conditions
-----------------
Hyperglycaemia During Perioperative Period, Heart Valve Diseases, Ventricular Dysfunction

Intervention / Treatment
-----------------
* Drug: human regular insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult more than 21 years old open heart surgery with cardiopulmonary bypass Exclusion Criteria: renal dysfunction reoperation use of inotropic support neurological dysfunction chronic pulmonary obstructive disease emergency or urgency

Ages Eligible for Study
-----------------
Minimum Age: 21 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: human regular insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of intubation |  |  | 
| ICU length |  |  | 
| Blood transfusion |  |  | 
| Infection rate |  |  | 
| Renal dysfunction |  |  | 
| Neurological dysfunction |  |  | 
| Hospital length |  |  | 
| Mortality |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of surgery |  |  | 
| Length of cardiopulmonary bypass |  |  | 
| Physical status |  |  | 
| EuroSCORE |  |  | 
| Parsonnet |  |  | 
| Canadian Multicenter index |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyperglycaemia, open heart surgery, intensive care unit
Non-rebreather at Flush Rate Compared to Bag Valve Mask With Assist

Study Overview
=================
Brief Summary
-----------------
This crossover investigation enrolls healthy volunteers and compares the exhaled oxygen content (FeO2) between the non-rebreather mask at the flush rate and a bag-valve-mask device at the flush rate, used with active positive pressure assistance.

Conditions
-----------------
Acute Respiratory Failure

Intervention / Treatment
-----------------
* Other: Flush rate oxygen
* Other: Flush rate oxygen with assist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >17 Exclusion Criteria: Pregnant Any facial hair more than stubble that might impede a mask seal

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-rebreather<br>This group will have a non-rebreather mask applied to the face and they will receive the flush rate oxygen intervention | Other: Flush rate oxygen<br>* Using a standard flowmeter (Precision Medical, 8MFA), the flow of oxygen will be fully opened and oxygen will be administered for three minutes.<br>|
| Active Comparator: Bag-valve-mask<br>With each inspiration from the subject, the ventilation bag will be gently squeezed to provide positive pressure and augment the amount of oxygen that is received by the subject for each breath. This group will receive the flush rate oxygen with assist intervention. | Other: Flush rate oxygen with assist<br>* Using a standard flowmeter (Precision Medical, 8MFA), the flow of oxygen will be fully opened and oxygen will be administered for three minutes. Positive pressure breaths to match the subject's inspiration will be provided during the three minute period.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fraction of expired oxygen | The fraction of expired oxygen will be measured after three minutes of preoxygenation | 3 minutes |
Electrophysiology in Congenital Cataract After Lensectomy and Anterior

Study Overview
=================
Brief Summary
-----------------
In this prospective study , a cohort of 91 eyes with congenital cataract and 25 eyes normal eyes from Wenzhou medical university was erolled.91 eyes with congenital cataract was after lensectomy and anterior vitrectomy as test group, 25 normal eyes as control group. The a- and b-wave and PhNR related parameters was evaluated.

Detailed Description
-----------------
Secondary IOL implantation in aphika children and lensectomy and anterior vitrectomy and primary IOL implantation in children with congenital cataract were both performed by the same surgeon(Z.Y.E). electroretinography and photopic negative response are performed to each patient.The research was to evaluate the relationship between the best corrected visionn and the related parameters of a- and b-wave and PhNR .

Official Title
-----------------
The Change of Electrophysiology in Congenital Cataract After Lensectomy and Anterior Vitrectomy

Conditions
-----------------
Congenital Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: phakic children diagnosed with congenital cataract who underwent secondary IOL implantation and children with congenital cataract who underwent lensectomy and anterior vitrectomy and primary IOL implantation Exclusion Criteria: patients with mild cataracts do not require surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 15 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 |
| --- | --- |
| congenital cataract group<br>children with congenital cataract who underwent lensectomy and anterior vitrectomy and IOL implantation are perfomed ERG | |
| age-matched normal children group<br>age-matched normal children are perfomed ERG | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ERG | investigate retinal function changes of congenital cataract children. ERG related parameters including a- and b-wave and PhNR amplitude and latency. | at least 1year after the surgery of congenital cataract | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERG
Quick Diagnostic Program for Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
Head and neck cancer would be suitable for quick diagnostic programs because their initial symptoms are easy detectable and the curation rates in the initial stages are very high. Actually the stages at diagnosis are about 30% in initial stages and 70% in advanced stages. The hypothesis of this study is that a program for quick referral of patients with symptoms of head and neck cancer would help early diagnosis.

Conditions
-----------------
Cancer of Head and Neck

Intervention / Treatment
-----------------
* Other: Quick diagnosis program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with symptoms of head and neck cancer in the Hospital reference area Exclusion Criteria: Patients already diagnosed when refered to Hospital
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| New diagnosed patients of head and neck cancer<br>New diagnosed patients of head and neck cancer | Other: Quick diagnosis program<br> <br> |
| Old diagnosed head and neck cancer patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from symptom onset to diagnosis |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer diagnosis
Randomized Controlled Trial of Doxycycline to Prevent Acquisition of Mycoplasma Pneumoniae in an Outbreak Setting

Study Overview
=================
Brief Summary
-----------------
This study was designed to determine whether taking daily doxycycline during an outbreak of Mycoplasma pneumoniae could prevent a person from getting infected and interrupt ongoing disease transmission during an outbreak. Doxycycline is a treatment for Mycoplasma pneumoniae, but it is not certain that the drug could prevent disease if used prophylactically.

Official Title
-----------------
A Double-Blind, Randomized Placebo-Controlled Trial of Doxycycline for Chemoprophylaxis in the Setting of an Outbreak of Mycoplasma Pneumoniae

Conditions
-----------------
Mycoplasma Pneumoniae

Intervention / Treatment
-----------------
* Drug: Doxycycline treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Working at hospital facility where outbreak of Mycoplasma pneumoniae occured Exclusion Criteria: - Pregnant, on antiseizure medications, allergic to macrolide antibiotics

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Doxycycline treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Case Management for Crack Users Who Seek Treatment in CAPSad in Brazil

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of a Case Management (CM) intervention in crack users applied in Psychosocial Care Centers - Alcohol and Drugs (CAPSad) by trained social workers, in comparison to CAPSad conventional treatment on 30 and 90 days, considering the following outcomes: treatment retention, abstinence and changes in severity scores of the sixth version of Addiction Severity Index (ASI6) scale. The study hypothesis are: 1) The CM is going to improve the retention of crack users (cases) during the 3-month follow-up compared with usual care (controls); 2)Individuals who received the intervention with GC are going to present a higher rate of abstinence; 3)The summary scores of the ASI6 will be significantly lower in cases than in controls, at the end of 3 months follow-up.

Official Title
-----------------
Effectiveness of Case Management for Crack Users Who Seek Treatment in CAPSad in Six Brazilian Capitals

Conditions
-----------------
Crack Abuse or Dependence

Intervention / Treatment
-----------------
* Behavioral: Case Management (Strength-Based)
* Behavioral: Usual Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of crack abuse or dependence > 18 years old Initiating treatment (maximum of 1 month) Exclusion Criteria: Homeless without permanent contact Psychotic symptoms during the intake interview

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case management<br> | Behavioral: Case Management (Strength-Based)<br>* To improve the cases sharing between CAPSad and other health institutions and individuals and increase the strengths of the patient to cope with problems related to the crack use.<br>|
| Active Comparator: Usual treatment<br>Usual treatment of the CAPSad | Behavioral: Usual Treatment<br>* The usual treatment used for regular patients of CAPSad<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment retention |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crack abstinence |  | 3 months | 
| ASI subareas scores | ASI (Addiction Severity Index) | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Case Management, Crack abuse/dependents, Evaluation, Inpatient, Treatment retention, Abstinence, ASI
Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia, Europe, Middle East, and North America. The primary objective of the trial is to evaluate the safety of Recombinant Activated Factor VII in patients with brain contusions. The secondary objective of the trial is to evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing early haemorrhagic progression in contusive brain injury.

Official Title
-----------------
A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Recombinant Factor VIIa (NovoSeven®/NiaStase®) in Subjects With Brain Contusions

Conditions
-----------------
Acquired Bleeding Disorder, Trauma

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Contusive brain injury (including brain stem) diagnosed by history, clinical examination and confirmed by CT scan within 6 hours of onset In British Columbia and Nova Scotia, subjects must be = 19 years.

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

| Intervention/Treatment |
| --- |
|Drug: activated recombinant human factor VII|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Safety of Recombinant Activated Factor VII in Subjects with Brain Contusions |  | Within the first 15 days of injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing haemorrhagic progression in brain contusions |  |  |