linjc16/ctgov huggingface dataset:
Feasibility Study of Neoadjuvant Chemotherapy Modified FOLFOX6 for Resectable Liver Metastases of Colorectal Cancers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of liver resection for metastatic, resectable lesions from colorectal cancers after systemic chemotherapy.

Conditions
-----------------
Colorectal Cancer, Liver Metastasis

Intervention / Treatment
-----------------
* Procedure: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically diagnosed as colorectal adenocarcinomas, including cecal, appendiceal, and anal canal cancers. Liver lesions are measurable by spiral CT or SPIO-MRI scans. Extrahepatic lesions include lung metastases which can be resected curatively. Curative resection for metastatic lesions can be performed with residual hepatic functions preserved. No prior treatment histories for liver lesions, including L-OHP regimens, hepatectomy, hepatic arterial infusion, MCT, or RFA No evidence of chronic hepatic diseases which affect systemic chemotherapy and/or surgical resection Performance status (ECOG): 0-1 Vital organ functions, including hematopoietic, cardiac, respiratory and renal functions, are preserved. Exclusion Criteria: Excluded are cases with conditions as below: Peritoneal or pleural fluid retention to be drained. Multiple malignancies to be treated. Peripheral neural disturbances. Active infectious diseases. Severe watery diarrhea. Mental disturbances. Treatment history of continuous, oral or intravenous steroid therapy. Previous history of ischemic heart diseases. Coexistent severe diseases including pulmonary fibrosis, interstitial pneumonia, ileus, uncontrollable diabetes, cardiac dysfunction, hepatic failure, or renal failure. Pregnant. Previous history of severe drug-induced allergy.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Procedure: Surgery<br>* Liver resection for metastatic liver lesions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Curative resection rates of liver metastases |  | 2 years after the operations | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion rates of neoadjuvant chemotherapy |  | 2 years after the operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neoadjuvant chemotherapy, Metastatic liver lesions from colorectal cancers
Optimized Glycemic Control in Heart Failure Patients With DM2:Effect on Left Ventricular Function and Skeletal Muscle

Study Overview
=================
Brief Summary
-----------------
The investigators wish to investigate wether a more strict diabetic control improves cardiac function, muscle strength, exercise capacity and decreases symptoms. The investigators hypothesis is that improving the glycemic control in suboptimized diabetics with heart failure will improve cardiac performance, muscle strength, exercise capacity and decrease symptoms.

Official Title
-----------------
Optimized Glycemic Control in Type 2 Diabetics With Heart Failure:Effect on Left Ventricular Function and Skeletal Muscle

Conditions
-----------------
Type 2 Diabetes, Heart Failure

Intervention / Treatment
-----------------
* Other: all antidiabetic drugs will be appliable


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ejection fraction =<45% Diabetes Hba1c =>7,5% In anticongestive treatment NYHA class 2-4 Exclusion Criteria: Severe angina (CCS 3-4) Hemodynamic significant heart valve disease Congenital heart disease Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Experimental: optimized diabetic control<br>each participant will be assigned to be optimized in a dedicated diabetic clinic | Other: all antidiabetic drugs will be appliable<br>* We expect all participants to be set on insulin during the intervention, however all types of insulin and other antidiabetics can be used goal: Hba1c lower than 7,5%<br>|
| No Intervention: control<br>participants will be assigned to follow what ever control they were in before the study and not to change any antidiabetic treatment during the interventions period. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular function | Left ventricular function will be evaluated using echocardiografi measuring: - 2D Ejection fraction (using an ultrasound agent), global and regional tissue velocity, Strain / strain rate - all measures done during rest and dobutamin stress test. | 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hormonal and metabolic profile | bloodsamples | 4 month | 
| 6-minutes hall walk test | using a hall walk protocol | 4 month | 
| Exercise capacity and peak oxygen consumption | using a treadmill test and continues oxygen consumption measurement | 4 month | 
| Muscle strength and mass | muscle strength: hand grip test | 4 month |
CONSERVE Plus Post-Approval Study (PAS)

Study Overview
=================
Brief Summary
-----------------
The objective of this post-approval study is to provide scientifically valid and reliable evidence that supports claims of longer term safety and effectiveness with regard to Month 120 device survivorship rates.

Detailed Description
-----------------
This study will evaluate the performance of CONSERVE Plus Hip Resurfacing System under actual conditions of use. Additionally, this study will evaluate the performance of the device in the post approval environment to see if there are any significant changes in device performance as compared to the pre-market IDE Study

Official Title
-----------------
Conserve Plus Total Hip Resurfacing System: A Non-Randomized, Multi-center, NewEnrollement Post Approval Study

Conditions
-----------------
Other and Unspecified Injury to Hip and Thigh

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Was previously enrolled in the CONSERVE® Plus IDE as part of the All Enrolled Audited Cohort (N=1366 procedures (1206 patients)) and received the Original Shell. Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form. Exclusion Criteria: Patient is mentally incompetent. Patient is a prisoner. Patient is an alcohol and/or drug abuser Patient has undergone device revision or removal

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CONSERVE® Plus hip resurfacing<br>Recipients/C Plus (IDE)study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success at Month 120 | Clinical success at Month 120 for each patient will be survivorship, defined as freedom from revision or removal for any aseptic reason and at least good function/pain relief defined as Harris Hip Score ≥ 80. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic outcomes | Secondary measures: radiographic outcomes | 10 years | 
| Metal Ion (serum) | metal ion (serum) and renal function will also be collected. | 24 months | 
| Assessment for Adverse Events | Subjects will be assessed for any adverse events during their length of participation | 10 years | 
| Measurement of Patient Satisfaction | Patient satisfaction as assessed by the SF-12 | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Efficacy
German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms

Study Overview
=================
Brief Summary
-----------------
This PMS study had the objective to evaluate under ordinary medical care conditions the efficacy and tolerability of esomeprazole in patients who where treated by general practitioners and internists.

Official Title
-----------------
German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms

Conditions
-----------------
Gastroesophageal Reflux

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with GERD, or NSAID related ulcers, who need treatment with esomeprazole. Exclusion Criteria: Limitations; possible risks; warnings; contraindications mentioned in the SPC.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>patients with GERD or NSAID-related ulcers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To gain further insight into the efficacy of esomeprazole under ordinary medical care conditions in consideration of diagnosis and type of NSAID therapy (if administered). |  | By estimating the proportion of treated subjects without any gastrointestinal symptoms at the end of the observational period 2. by assessing the change in intensity of gastrointestinal symptoms. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To get further insight into the details of the use, dosage scheme and duration of treatment with esomeprazole in this population |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
reflux, NSAR treatment, Patients with reflux symptoms or gastrointestinal symptoms after NSAR Treatment
Assessment of Sexual Dysfunction, Depression and Anxiety in Underserved, Minority Gynecologic Cancers Patients

Study Overview
=================
Brief Summary
-----------------
Objectives: Assess the prevalence and severity of depression and anxiety in underserved and minority women seen in the gynecologic oncology clinic at Lyndon Baines Johnson General Hospital. Assess the prevalence and severity of sexual dysfunction in this patient population.

Detailed Description
-----------------
The instruments used in this study will be completed at one timepoint, by those women who choose to participate, anonymously. The questionnaires will be preceded with a statement informing the patient that by completing the study questionnaires she is consenting to study participation. No patient names or medical record numbers will be documented. When a patient checks in for her clinic appointment, she will receive a packet of study materials consisting of a cover letter describing the study objectives, the Female Sexual Function Index, the Hospital Anxiety and Depression Scale, and a demographic questionnaire. The tools used in this study will be available in both English and Spanish.

Official Title
-----------------
Assessment of the Prevalence of Sexual Dysfunction, Depression, and Anxiety in Underserved and Minority Patients With Gynecologic Cancers

Conditions
-----------------
Gynecologic Cancer

Intervention / Treatment
-----------------
* Behavioral: Surveys


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Women seen at the Gynecologic Oncology Clinic at the Lyndon Baines Johnson General Hospital. The women must be able to read and write either English or Spanish. Exclusion Criteria: - Women who are unable to complete the questionnaires.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Psych Needs Assessment<br>Female Sexual Function Index (FSFI), Hospital Anxiety and Depression Scale (HADS), and a demographic questionnaire given to underserved and minority women with a gynecologic cancer or premalignant condition. | Behavioral: Surveys<br>* Surveys -- Female Sexual Function Index (FSFI), the Hospital Anxiety and Depression Scale (HADS), and a demographic questionnaire completed at time of clinic appointment, taking about 20 minutes.<br>* Other names: Questionnaire;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Sexual Dysfunction, Depression, and Anxiety in Patients Surveyed |  | Survey perfomed at single point in time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Gynecology, Sexual Dysfunction, Depression, Anxiety, Underserved, Minority, Psychological distress
Prevalence of Sonographic Abnormalities of Joints and Entheses in Psoriasis Patients With or Without Musculoskeletal Complains

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are: to estimate the prevalence and severity of inflammatory (synovitis, tenosynovitis, enthesitis, dactylitis) and structural (erosions, osteophytes, enthesophytes, cortical irregularities ) ultrasound lesions in psoriasis patients with or without related musculoskeletal symptoms; to compare them to healthy subjects or patients suffering from rheumatoid arthritis and osteoarthritis.

Official Title
-----------------
Prevalence of Sonographic Abnormalities of Joints and Entheses in Patients With Psoriasis With or Without Musculoskeletal Complains

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Other: Ultrasound examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years; Psoriasis diagnosed by a dermatologist; Able to participate in the study; Informed consent signed. Exclusion Criteria: - Chronic disease likely to cause musculoskeletal symptoms (connective tissue diseases, inflammatory bowel diseases, overload disorders, crystal related arthritis, septic arthritis...).

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Psoriasis with and without musculoskeletal complains<br>psoriasis with and without musculoskeletal complains | Other: Ultrasound examination<br>* Ultrasound examination of joints, tendons and entheses.<br>|
| Healthy individuals<br> | Other: Ultrasound examination<br>* Ultrasound examination of joints, tendons and entheses.<br>|
| Psoriatic arthritis<br> | Other: Ultrasound examination<br>* Ultrasound examination of joints, tendons and entheses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| synovitis | Number and percentage, N (%) of patients with at least one synovitis. | through study completion, an average of 1 year | 
| enthesitis | N (%) of patients with at least one ultrasound enthesitis. | through study completion, an average of 1 year | 
| joint erosion | N (%) of patients with at least one joint erosion. | through study completion, an average of 1 year | 
| osteophyte/ cortical irregularity | N (%) of patients with at least one osteophyte/ cortical irregularity. | through study completion, an average of 1 year | 
| enthesophyte | N (%) of patients with at least one enthesophyte. | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psoriasis, psoriatic arthritis, ultrasound
Lanreotide and Octreotide Long Acting Release (LAR) for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Study Overview
=================
Brief Summary
-----------------
An observational time and motion study in a clinical oncology setting is utilized in order to measure and compare product attributes and overall product efficiency between lanreotide and octreotide LAR.

Official Title
-----------------
Lanreotide and Octreotide LAR for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): An Observational Time and Motion Analysis

Conditions
-----------------
Gastroenteropancreatic Neuroendocrine Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women must be 18 years of age or older A current diagnosis of advanced, unresectable GEP-NET Provided written informed consent to participate in the study Currently receiving lanreotide or octreotide LAR and has received at least one prior injection of current somatostatin analogues (SSA). Exclusion Criteria: Receiving treatment with lanreotide or octreotide LAR as part of a clinical trial Scheduled to receive a dose of lanreotide or octreotide LAR that would necessitate more than 1 injection on the same day Scheduled to receive any other treatment in the infusion center/room on the same day and as part of the same appointment Known hypersensitivity to somatostatin analogues

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| lanreotide group (Somatuline Depot®)<br> | |
| octreotide LAR group (Sandostatin LAR®)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total time for product preparation and administration | Total drug delivery time | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total patient wait time for administration | For the purposes of this study, total patient wait time refers to the time the patient checks in at the infusion room until completion of drug administration and discharge of the patient from the infusion room. | Day 1 | 
| Number of clogging episodes | The number of clogging episodes for lanreotide and octreotide LAR will be recorded and compared. | Day 1 | 
| Healthcare resource utilization | The materials used for the preparation of lanreotide and octreotide LAR will be recorded and compared. | Day 1 | 
| Pharmacist and/or nurse satisfaction and product preference | Assessed by pharmacist and/or nurse completing questionnaire | Day 1 and at the end of the study (approximately 3 months) | 
| Patient satisfaction | Assessed by patient completing questionnaire | Day 1 |
High Flow in Infants With Bronchiolitis

Study Overview
=================
Brief Summary
-----------------
In this multi-centre randomized controlled trial the investigators compare the effect on dyspnoea severity of oxgen delivery through High Flow Nasal cannula with Low Flow Nasal Prongs in children < 2 years of age hospitalised for bronchiolitis with moderate-severe dyspnoea.

Detailed Description
-----------------
In this multi-centre randomized controlled trial the investigators compare the effect on dyspnoea severity of oxgen delivery through High Flow Nasal Cannula with Low Flow Nasal Prongs in children < 2 years of age hospitalised for bronchiolitis with moderate-severe dyspnoea. The study will take place on the pediatric (Non intensive care) units of 5 different hospitals in the Netherlands.

Official Title
-----------------
High Flow Nasal Cannula Therapy for Infants With Bronchiolitis

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Other: High Flow Nasal Cannula
* Other: Low Flow Nasal Prongs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bronchiolitis PEWS (Pediatric Early Warning Score 0-28) >= 6 oxygen saturation < 92% Exclusion Criteria: chronic lung disease hemodynamic significant heart disease syndromal disease facial abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 1 Week
Maximum Age: 24 Months

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Flow Nasal Cannula<br>Oxygen delivery through Heated Humidified High Flow Nasal Cannula | Other: High Flow Nasal Cannula<br>* Oxygen delivery through Heated Humidified High Flow Nasal Cannula<br>* Other names: HFNC;|
| Active Comparator: Low Flow Nasal Prongs<br>Oxygen delivery through Low Flow Nasal Prongs | Other: Low Flow Nasal Prongs<br>* Oxygen delivery through Low Flow Nasal Prongs<br>* Other names: LFNC;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PEWS (Pediatric Early Warning Score) (in points 0-28) | Sustained reduction in PEWS >= 2 points within 24 hours (min 0- max 28 points) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort (in points 0-10) | (FLACC: Face, Legs, Activity, Cry, Consolability, min 0- max 10 points) | 24 hours | 
| ability to feed (yes or no) | need for tubefeeding and/or intravenous fluids | 5 days | 
| duration of hospitalisation in days | duration of hospitalisation in days | 15 days | 
| admission to PICU (Pediatric Intensive Care Unit) (yes or no) |  | 5 days |