linjc16/ctgov huggingface dataset:
Psychological Health Influences the Choice of Device in Proximal Humeral Fractures

Study Overview
=================
Brief Summary
-----------------
It was conducted a prospective study with a series of 63 patients treated with O.R.I.F. (Open Reduction and Internal Fixation) (group A) and with RSA (Reverse Shoulder Arthroplasty) (group B) for three and four-part proximal humeral fractures according to Neer classification system. One independent observer performed clinical and a psychological evaluation at one(T0), six(T1) and twelve months(T2) postoperatively. The Constant's score and The Disabilities of the Arm, Shoulder and Hand (DASH score) were used for clinical evaluation, while General Anxiety Disorder-7 (GAD-7) and Caregiver Strain Scale (CSS) were used for psychological evaluation.

Official Title
-----------------
Angle Stable Plate Versus Reverse Shoulder Treatment for Proximal Humeral Fractures: Should the Psychological Health Influence the Choice of Device

Conditions
-----------------
Humeral Fracture, Proximal

Intervention / Treatment
-----------------
* Procedure: Three and four-part proximal humeral fractures' treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Three and four-part proximal humeral fractures according to Neer classification system; Patients seventy years or older; Shoulder surgery within one week after trauma Exclusion Criteria: Exposed fractures; Pathological fractures; Proximal humerus fractures with metaphyseal or diaphyseal extension; Contraindications to surgery associated with organ dysfunctions or with coagulopathy; Allergy or hypersensitivity to the orthopedic implants; Patients who were unable to attend the different follow-ups; Patients with psychiatric disorders

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients treated by angle stable plate PHILOS<br> | Procedure: Three and four-part proximal humeral fractures' treatment<br>* Open Reduction and Internal Fixation with angle stable plate PHILOS versus RSA (Reverse Shoulder Arthroplasty<br>|
| patients treated by reverse total shoulder arthroplasty SMR<br> | Procedure: Three and four-part proximal humeral fractures' treatment<br>* Open Reduction and Internal Fixation with angle stable plate PHILOS versus RSA (Reverse Shoulder Arthroplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Constant's score | The shoulder functionality was quantified using the Constant's score ranging between 0 (most disability) and 100 points (least disability). | T0 (one-month), T1 (six months), T2 (one year) post operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open reduction and fixation, Reverse shoulder arthroplasty
Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced NSCLC

Study Overview
=================
Brief Summary
-----------------
This study aims to explore Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China

Detailed Description
-----------------
inclusion criteria Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer EGFR G719X, exon 20 insert mutation without any anti-cancer treatment history

Official Title
-----------------
Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China

Conditions
-----------------
Non-small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology Uncommon EGFR Mutant Advanced NSCLC Exclusion Criteria: Patients with contraindication of chemotherapy Pregnant or breast feeding women

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | may 2020- may 2021 (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | may 2020- may 2021 (1 year) | 
| ORR | To measure the patients's overall response rate | may 2020- may 2021 (1 year) |
A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized, double-blind, placebo-controlled, parallel-group, three-arm, multicenter study of the safety and PK of ELND005 administered orally for 4 weeks. This study will enroll Down Syndrome patients 18 to 45 years of age (inclusive) without dementia.

Official Title
-----------------
A 4-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2a Safety and PK Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia

Conditions
-----------------
Down Syndrome

Intervention / Treatment
-----------------
* Drug: ELND005
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 45 years of age Has an IQ of > 40 (K-BIT) Able and willing to have a brain MRI Exclusion Criteria: Symptoms of dementia or worsening cognition over the past year. Has a history of hepatitis B, hepatitis C, or HIV

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ELND005 BID<br>ELND005 250 mg BID | Drug: ELND005<br> <br> |
| Experimental: ELND005 QD<br>ELND005 250 mg QD | Drug: ELND005<br> <br> |
| Placebo Comparator: Placebo<br>Placebo BID | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (TEAEs) | For all AE summaries, if a patient had more than one AE within a preferred term, the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a SOC, the subject was similarly counted only once when reporting results for that SOC. | 4 weeks |
Telithromycin, Treating Adult Outpatients With Mild to Moderate Community-acquired Pneumonia (CAP) in High Bacterial Resistance Areas

Study Overview
=================
Brief Summary
-----------------
Demonstrate efficacy of telithromycin over single-agent oral antibiotics usually prescribed by local guidelines (usual care) for treating adult outpatients with mild to moderate community-acquired pneumonia (CAP) in high bacterial resistance areas.

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Drug: Telithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult outpatients with mild to moderate CAP. Diagnosis of CAP was based on the presence of fever and/or hyperleucocytosis and the new and sudden onset of at least two clinical signs and symptoms of pneumonia (cough, dyspnea or tachypnea, chills, pleuritic chest pain, purulent sputum or change in sputum character, auscultatory findings). Clinical diagnosis of CAP had to be confirmed by chest X-ray findings (e.g. presence of presumably new infiltrate). Specimens for microbiological documentation had to be collected within 24 hours prior to enrollment. Exclusion Criteria: Subjects requiring parenteral antibiotic treatment. Subjects with severe CAP requiring hospitalization. The CAP was to be considered as severe in the presence of any of the following conditions: chest X-ray showing a multilobar consolidation (> 1 lobe)3 and/ or an increase in the size of the opacity by greater than or = to 50% within 48 hours of the current evaluation shock altered mental status (disorientation to person, place or time that is not known to be chronic, lethargy, stupor or coma) total peripheral white blood cell count < 4,000/mm3 requirement for mechanical ventilation requirement for vasopressors acute renal failure The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Telithromycin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effect of telithromycin versus usual care on the total symptoms score of pneumonia and on health outcomes, in CAP adult outpatients at the end of therapy visit. |  | (Days 8-11) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For health outcomes at the test of cure visit; e.g. additional LRTI-related antibiotic use, LRTI related hospitalization with length of stay and LRTI related office visit/emergency room visit. |  | (Days 17-21) |
COMPARATIVE EFFECTS OF PERIOPERATIVE AND ADJUVANT CHEMOTHERAPY ON OUTCOMES OF OPERABLE GASTRIC CANCER: EXPERIENCE FROM A CANCER CARE CENTER

Study Overview
=================
Brief Summary
-----------------
Patients with gastric adenocarcinoma Comparison: perioperative chemotherapy vs. adjuvant therapy. Sample size differences between the two groups. Kaplan meier survival analysis, overall survival and disease free survival

Official Title
-----------------
COMPARATIVE EFFECTS OF PERIOPERATIVE AND ADJUVANT CHEMOTHERAPY ON OUTCOMES OF OPERABLE GASTRIC CANCER: EXPERIENCE FROM A CANCER CARE CENTER

Conditions
-----------------
Gastric Cancer, Outcomes, Pakistan, Adjuvant Chemotherapy, Perioperative Chemotherapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We included histologically proven gastric adenocarcinoma patient with operable disease and the patients who completed their prescribed perioperative or adjuvant chemotherapy cycles Exclusion Criteria: Patients were excluded if they had Tis or T1, N0 disease, inoperable disease, metastatic. In addition, all those who did not undergo adequate lymphadenectomy (< D2) or had R1 margins following surgery were excluded

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| perioperative chemotherapy vs. adjuvant therapy in gastric ca patients<br> | |
| perioperative chemotherapy group vs. adjuvant chemotherapy group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The overall survival | The overall survival (OS) was defined as the length of the time from date of diagnosis till last follow-up or death | from January 2015 till December 2019 | 
| The disease-free survival | The disease free survival (DFS) as the length of the time from date of last treatment which is either perioperative or adjuvant chemotherapy to tumor relapse or death. | from January 2015 till December 2019 |
Study Of Single Doses Of PF-06291826 (Tafamidis) In Japanese And Western Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the following: To evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered tafamidis in Japanese and Western healthy volunteers at single dose. To compare Japanese and Western PK profiles. Determine the PD stabilization effect of tafamidis on human transthyretin (TTR) in a validated ex vivo assay.

Official Title
-----------------
An Investigator And Subject-Blind Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06291826 (Tafamidis) After Single Oral Administration To Japanese And Western Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Tafamidis meglumin
* Drug: Tafamidis meglumin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or females. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2. Exclusion Criteria: Pregnant or nursing females. Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20 mg soft gelatin capsule<br> | Drug: Tafamidis meglumin<br>* A single oral dose of 20 mg capsule<br>* Other names: PF-06291826;|
| Experimental: 40 mg (20 mg*2) soft gelatin capsule<br> | Drug: Tafamidis meglumin<br>* A single oral dose of 40 mg capsule.<br>* Other names: PF-06291826;|
| Active Comparator: Placebo<br> | Drug: Placebo<br>* A single oral dose of matched placebo.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of tafamidis over time (AUClast). |  | 2 months | 
| Plasma concentration of tafamidis over time (Cmax). |  | 2 months | 
| Plasma concentration of tafamidis over time (Tmax). |  | 2 months | 
| If data permit, AUCinf and t1/2 will be determined. |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent stabilization of TTR tetramer will be defined at Cmax in each subject and compared between Japanese volunteers and Western volunteers. |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tafamidis, Pharmacokinetics, TTR stabilization
Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
This is a clinical research study designed to evaluate an investigational new medication called sitaxsentan for the treatment of pulmonary arterial hypertension (patients with NYHA functional class II, III or IV). The purpose of this study is to evaluate the safety and effectiveness of two different doses of sitaxsentan, compared to placebo (inactive treatment) for the treatment of pulmonary arterial hypertension. Patients who complete this trial may be eligible to take part in an extension trial (Protocol FPH01-X). Eligible patients who receive placebo in the 12-week study cross over to receive sitaxsentan for the extension trial.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Drug: sitaxsentan sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NYHA Class II, III or IV 16 to 75 years of age Specific peak VO2 range PPH, PAH due to connective tissue disease or select congenital heart disease Qualifying cardiac catheterization History of CXR and qualifying pulmonary function test History of qualifying ventilation-perfusion lung scan History of qualifying echocardiogram Women of childbearing potential must use contraceptives Stable dose of corticosteroids if prescribed Exclusion Criteria: Significant lung disease Chronic liver disease Uncontrolled sleep apnea History of specific types of left heart disease Any disorder that compromises ability to give informed consent Uncontrolled sleep apnea Inability to perform bicycle exercise test On-going treatment with an experimental drug or device within the last 30 days HIV infection Specific liver dysfunction Chronic renal disease Pregnancy/Nursing Chronic active hepatitis B or C Chronic Flolan or Tracleer use within the last 30 days

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 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: sitaxsentan sodium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Expanded Access to Rovalpituzumab Tesirine

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Rovalpituzumab Tesirine prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Official Title
-----------------
Expanded Access to Rovalpituzumab Tesirine

Conditions
-----------------
Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: rovalpituzumab tesirine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant must not be eligible for a Rovalpituzumab Tesirine clinical trial. Pediatric participants may be evaluated on a case by case basis. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rovalpituzumab tesirine|intravenous|

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
-----------------
Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and tolerability of fluvastatin 80 mg in a Chinese population. This study is not recruiting patients in the US.

Official Title
-----------------
Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia

Conditions
-----------------
Mixed Dyslipidemia, Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Fluvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mixed dyslipidemia Primary hypercholesterolemia Exclusion Criteria: Pregnant or lactating women Age > 18 years Other protocol-defined inclusion and exclusion criteria may apply.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline in low density lipoprotein cholesterol after 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline in total cholesterol after 12 weeks |  |  | 
| Percent change from baseline in high density lipoprotein cholesterol after 12 weeks |  |  | 
| Percent change from baseline in total triglycerides after 12 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high cholesterol, Mixed Dyslipidemia, adults, fluvastatin