linjc16/ctgov huggingface dataset:
Phase 1 Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Relapsed/Refractory Solid Tumors

Study Overview
=================
Brief Summary
-----------------
Phase 1, open-labeled, dose escalation safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.

Official Title
-----------------
A Phase 1, Open Label, Dose Escalation Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Subjects With Relapsed or Refractory Solid Tumors

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: BIIB022


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older at the time of informed consent Relapsed or refractory solid tumors following standard therapy. ECOG Performance Status 0 or 1. Exclusion Criteria: History of insulin-dependent diabetes, type 2 diabetes, or hemoglobin A1c >6% at screening. History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure. Known central nervous system or brain metastases. Prior anti-IGF-1R therapy of any kind. Other protocol-defined inclusion/exclusion criteria may apply.

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: BIIB022<br> | Drug: BIIB022<br>* IV infusion once every three weeks until disease progression or unacceptable toxicity<br>* Other names: IGF-1R;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of BIIB022 |  | ongoing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate pharmacokinetics |  | ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsed, refractory, solid tumor
Prehospital Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to measure the effect of Finnish physician-staffed EMS unit treatment methods on traumatic brain injury (TBI) patient prognosis.

Detailed Description
-----------------
A secondary aim is to identify out-of-hospital treatment factors that can be influenced by education and protocols.

Official Title
-----------------
Severe Traumatic Brain Injury - Comparison of Outcome in Paramedic Versus Physician Staffed Emergency Medical Services

Conditions
-----------------
Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TBI with GCS ≤ 8 or unconsciousness verified by an on-call neurosurgeon during admission to the hospital. Exclusion Criteria: Multiple trauma
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Physician-staffed<br>Patients treated by physician-staffed emergency medical service (EMS) unit | |
| Paramedic-staffed<br>Patients treated by paramedic-staffed emergency medical service (EMS) unit | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow outcome score |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Traumatic Brain Injury, EMS, Out-of-Hospital
Studies of Disorders and Mechanisms Related to Atrial Fibrillation Before and After DC-Conversion.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if breathing disorders are related to atrial fibrillation and if it is possible to predict recurrence of atrial fibrillation after DC-conversion by changes in heart rate variability and 24 hour ECG.

Official Title
-----------------
Studies of Disorders and Mechanisms Related to Atrial Fibrillation Before and After DC-Conversion: Polysomnography, Heart Rate Variability and 24h Holter.

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: persistent atrial fibrillation scheduled for electrical cardioversion Exclusion Criteria: known obstructive sleep apnea
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation
Comparison Between Two Different Volumes of Anesthesia Drug in Forearm Surgery

Study Overview
=================
Brief Summary
-----------------
Hospitalized patients for superior member surgery have different types of anesthesia.Forearm and/or arm surgery could be done under general anesthesia, but in the most of the cases, this surgery was done under locoregional anesthesia.Several injections of local anesthesia at the nerves axilla are used with the used of ultrasonography. The purpose of this study is to show that the anesthesia efficiency is the same with 40 or 25 ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.

Detailed Description
-----------------
Inclusion criteria : age > 18 years old patient who must have a non emergency surgery of the forearm or the hand ASA I or ASA II informed consent Ensured patient Exclusion criteria : pregnancy respiratory insufficiency cardiac insufficiency hepatic insufficiency renal insufficiency ASA III or IV contraindications to the locoregional anesthesia contraindications to the xylocaine used patient participate to an another clinical study guardianship patient

Official Title
-----------------
Comparison of Axillary Block Under Ultrasound With 40 or 25 ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.

Conditions
-----------------
Forearm and Arm Surgery

Intervention / Treatment
-----------------
* Drug: Xylocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years old patient who must have a non emergency surgery of the forearm or the hand ASA I or ASA II informed consent Ensured patient Exclusion Criteria: pregnancy respiratory insufficiency cardiac insufficiency hepatic insufficiency renal insufficiency ASA III or IV contraindications to the locoregional anesthesia contraindications to the xylocaine used patient participate to an another clinical study guardianship patient

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 40 ml of Xylocaine<br> | Drug: Xylocaine<br>* 40 ml or 25 ml of Xylocaine injection<br>|
| Experimental: 25 ml of Xylocaine<br> | Drug: Xylocaine<br>* 40 ml or 25 ml of Xylocaine injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axillary block efficiency conducted by ultrasound | during the hospitalisation | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Forearm surgery, Hand surgery, Anesthesia
Non-invasive Measures of Distal Lung Disease in Asthmatics

Study Overview
=================
Brief Summary
-----------------
This is a Phase 4, single center study conducted in mild-to moderate asthmatics.

Detailed Description
-----------------
The study consists of 3 phases. There are 7 study visits.

Official Title
-----------------
Non-Invasive Measures of Distal Lung Disease in Asthmatics Before and After Therapy Directed at the Proximal vs. Distal Lung

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

Intervention / Treatment
-----------------
* Drug: QVAR
* Drug: Advair
* Drug: Servent Diskus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years old Currently using SABA prn or a low-to-moderate persistent asthma Exclusion Criteria: Tobacco use within 1 year or >= 5 pack years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Advair<br> | Drug: Advair<br>* 250/50 mcg<br>* Other names: Advair Diskus;|
| Experimental: QVAR<br> | Drug: QVAR<br>* 480 mcg<br>* Other names: beclomethasone dipropionate HFA;Drug: Servent Diskus<br>* 50 mcg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High resolution Cat Scans |  |  |
A New Prognostic Score Model for Pancreatic Ductal Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
The AJCC TNM staging system is the prevailing method in prognostic evaluation of pancreatic ductal adenocarcinoma (PDAC) at present , but it did not include factors such as the tumor immune microenvironment that are known to exert a profound impact on patients'clinical outcome. This study was aimed to develop a comprehensive and effective prognostic score model to predict prognosis and guide clinical management for postoperative PDAC patients.

Official Title
-----------------
Development and Validation of a New Prognostic Score Model Combining TNM Stage With Immune Risk Factors for Postoperative Pancreatic Ductal Adenocarcinoma

Conditions
-----------------
Neoplasms Pancreatic

Intervention / Treatment
-----------------
* Procedure: pancreatic cancer surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed PDAC Achievement of surgical resection (including radical or palliative surgery) Exclusion Criteria: Lost to follow-up Simultaneous presence of other tumors Died in three months after surgery
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The training cohort<br>To develop the prognostic model, 302 cases of postoperative PDAC were included in the final analysis and divided into the training and validation cohort by stratified sampling with 7:3 ratio (The training cohort: n=212; The validation cohort: n=90). | Procedure: pancreatic cancer surgery<br>* Surgical resection of pancreatic cancer，including radical or palliative surgery<br>|
| The validation cohort<br>To develop the prognostic model, 302 cases of postoperative PDAC were included in the final analysis and divided into the training and validation cohort by stratified sampling with 7:3 ratio (The training cohort: n=212; The validation cohort: n=90). | Procedure: pancreatic cancer surgery<br>* Surgical resection of pancreatic cancer，including radical or palliative surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | the number of months from the date of surgery to the date of the last follow-up visit or time of death. | after pancreatic cancer surgery until october 31, 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival disease-free survival disease-free survival disease-free survival | the number of months from the date of surgery to the date of first confirmable recurrence or death | after pancreatic cancer surgery until october 31, 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic ductal adenocarcinoma, prognostic model, tumor-infiltrating immune cell, staging
Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Single Ascending Dose Study

Official Title
-----------------
A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: AZD7268
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of Informed Consent Healthy male subjects and female subjects (of non-child bearing potential) with suitable veins for cannulation or repeated venipuncture Exclusion Criteria: Inability to understand or cooperate with given information Positive human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology, and urinanalysis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD7268<br>* Solution/Capsule, Oral, once daily<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of single ascending dose administration of AZD7268 when given orally to healthy male subjects and female subjects of non-childbearing potential. |  | Safety assessments are made at each visit, at least daily, during the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetics of AZD7268 in plasma and urine. |  | Blood and urine samples will be taken during the study. | 
| To assess the effect of food on the safety and pharmacokinetic profile of AZD7268. |  | Safety assessments and blood and urine samples will be taken throughout the study. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase 1
Study to Assess Safety, Tolerability and Pharmacokinetics After Single and Multiple Doses of AZD1446 to Japanese Subject

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects.

Official Title
-----------------
A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1446 in Healthy Young and Elderly Japanese Volunteers After Oral Single and Multiple Ascending Doses

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

Intervention / Treatment
-----------------
* Drug: AZD1446
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Japanese subjects, aged ≥20 to ≤50 years for male young subjects, ≥65 to ≤80 years for male or post-menopausal female elderly subjects. BMI between 18 and 27 kg/m2 and weigh at least 50 kg and no more than 90 kg (for the elderly female, weigh at least 45 kg and no more than 90 kg). Exclusion Criteria: History of Quincke oedema or angiooedema, or history of repeated episodes of urticaria. History or present symptoms or signs of asthma, airway hyperreactivity or obstructive lung disease.

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD1446 | Drug: AZD1446<br>* Oral solution Dose single and followed by 7-day multiple dosing.Specific doses depend on panel.<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Oral solution Dose single and followed by 7-day multiple dosing.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects by adverse events, vital signs, laboratory variables and ECG. |  | During the whole study period, ca. 50 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine pharmacokinetics(PK) of AZD1446 following single and multiple dosing of AZD1446 in healthy young and elderly Japanese subjects. |  | PK sampling taken at defined timepoints during residential period, 12 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, tolerability, AZD1446, AD, Japanese
Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study

Study Overview
=================
Brief Summary
-----------------
To examine the effectiveness of subcutaneous gamma interferon in reducing severity of Mycobacterium avium- intracellulare (MAI) bacillemia episodes in AIDS patients in an open-label dose-randomized multi-center pilot clinical investigation. To evaluate the safety of gamma interferon given by subcutaneous injection (SC) in the AIDS patient in the presence and absence of AZT therapy.

Official Title
-----------------
Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study

Conditions
-----------------
Mycobacterium Avium-Intracellulare Infection, HIV Infections

Intervention / Treatment
-----------------
* Drug: Trifluridine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Diagnosis of AIDS and persistent Mycobacterium avium- intracellulare (MAI) bacillemia. Life expectancy of at least 3 months. Baseline chest X-ray and EKG (electrocardiogram). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Known hypersensitivity to interferons or other exogenous lymphokine. History of cardiac abnormality or disease. History of hypertension. Patients with the following are excluded: Known hypersensitivity to interferons or other exogenous lymphokine. History of cardiac abnormality or disease. History of hypertension. Prior Medication: Excluded within 4 weeks of study entry: Corticosteroids. Anti-inflammatory medication (except aspirin). Changes in the dose of anti-mycobacterial drugs. Immune agents. Prior Treatment: Excluded within 4 weeks of study entry: Radiotherapy. Risk Behavior: Excluded: Intravenous drug abuse.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Trifluridine|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
-----------------
AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Interferon-gamma, Recombinant, Acquired Immunodeficiency Syndrome
Prospective Randomized Comparison of Conservative and Opertaive Treatment of Radius Fractures in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
Elderly Patients often suffer from radius fracture. Treatment options are conservative and operative. Aim of the stdy is to find out if there are diffrences in Patient's satisfaction depending on the different treatment. A randomized prospective trial is palnned

Detailed Description
-----------------
Patients of 70 years and more of age who suffer from C1 or C2 radius fracture are randomized treated by conservative treatment and operative treatment. Primary aim is PRWE, secondary ROM as well as power and DASH score.

Official Title
-----------------
Prospective Randomized Comparison of Conservative and Opertaive Treatment of Radius Fractures in Elderly Patients

Conditions
-----------------
Orthopedic Disorder

Intervention / Treatment
-----------------
* Device: Palmar Plate Fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radius Fractures C1-C2 age over 70 Exclusion Criteria: demetia collateral damages age < 70

Ages Eligible for Study
-----------------
Minimum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Operative Arm<br>Radius fractures C1/C2 treated by palmar plate fixation | Device: Palmar Plate Fixation<br>* Patients are treated by surgery (palmar plate)<br>|
| No Intervention: Conservative Arm<br>Radius Fractures C1/C2 treated by cast fixation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Related Wrist Evaulation | PRWE, ROM investigation | 12-24 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROM | PRWE, ROM, Investigation | 12-24 months post intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radius fracture, clinical outcome