linjc16/ctgov huggingface dataset:
Ragweed-SPIRE Follow-On Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of Ragweed-SPIRE 12 months after the initial dose.

Official Title
-----------------
An Observational Follow-On Field Study to Evaluate the Continued Efficacy and Safety of Ragweed-SPIRE Treatment in Ragweed Allergic Subjects Approximately One Year After the Completion of Treatment

Conditions
-----------------
Rhinoconjunctivitis, Ragweed Allergy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ° Previously randomised into and completed at least 6 of 8 treatment visits in Study TR006 Exclusion Criteria: Subject or Investigator have been informed of treatment received in Study TR006 Subjects with significant allergy to animal dander Any allergen immunotherapy since completing Study TR006 or use of prohibited therapies History of recurrent acute sinusitis or chronic sinusitis Received treatment with an investigational drug within 4 weeks of Screening Unable to understand study requirements or unable to communicate clearly with Investigator

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TR006 Subjects<br>Subjects that have previously been randomised into study TR006 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Rhinoconjunctivitis Symptom Score |  | Approximately 12 months after first dose in TR006 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue Medication Score |  | Approximately 12 months after first dose in TR006 | 
| Patient Global Assessment |  | Approximately 12 months after first dose in TR006 | 
| Skin Prick Test |  | Approximately 12 months after first dose in TR006 | 
| Immunoglobulin E Test |  | Approximately 12 months after first dose in TR006 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ragweed Allergy, Rhinoconjunctivitis, Immunotherapy, Ragweed-SPIRE
A Study to Assess CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose.

Study Overview
=================
Brief Summary
-----------------
A Study to Assess the Effect of CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM.

Official Title
-----------------
A Randomized, Double-Blind, Placebo and Comparator-Controlled Crossover Study to Assess Pharmacokinetic and Pharmacodynamic Effects of CT-868 on the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects With T2DM

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: CT-868 as SC Injection
* Drug: Placebo as SC Injection
* Drug: Active Comparator as SC Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Part 1: Obese Otherwise Healthy Males Part 2: Males or Females with T2D Part 1: BMI 30.0-35.0, inclusive Part 2: BMI 27.0-45.0, inclusive 18-65 years old, inclusive Stable body weight for 2 months Exclusion Criteria: Significant medical history Uncontrolled hypertension History of malignancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-868<br>SC dose of CT-868 Intervention: Drug: CT-868 | Drug: CT-868 as SC Injection<br>* CT-868<br>|
| Placebo Comparator: Placebo<br>SC dose of placebo matching CT-868 dose Intervention: Drug: Placebo | Drug: Placebo as SC Injection<br>* Placebo<br>|
| Active Comparator: Active Comparator<br>SC dose of Active Comparator Intervention: Drug: Active Comparator | Drug: Active Comparator as SC Injection<br>* Active Comparator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin secretion rate and ambient glucose levels |  | Baseline up to 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood insulin levels at each level of glucose infusion |  | Baseline up to 4 days | 
| Change in blood glucose levels at each level of glucose infusion |  | Baseline up to 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Diabetes Mellitus, Type 2, Overweight, Metabolic Diseases, Body Weight
LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research

Study Overview
=================
Brief Summary
-----------------
The present trial will investigate the efficacy and safety of nintedanib in combination with docetaxel as compared to placebo in combination with docetaxel in patients with stage IIIB/IV or recurrent NSCLC of adenocarcinoma histology after failure of first-line platinum-based chemotherapy.

Official Title
-----------------
Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral Nintedanib Plus Docetaxel Therapy Compared to Placebo Plus Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent, Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: docetaxel
* Drug: docetaxel
* Drug: placebo
* Drug: nintedanib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male or female patients of at least 18 years of age Histologically confirmed, adenocarcinoma of the lung, after failure of first line platinum-based chemotherapy. Exclusion criteria: More than one prior line of chemotherapy (i.e., 2nd or 3rd line chemotherapy) for advanced and/or metastatic (stage III B or IV NSCLC) or recurrent disease. Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation Previous therapy with other vascular endothelial growth factor (VEGF) or VEGFR inhibitors (other than bevacizumab) or docetaxel for the treatment of NSCLC at any time Prior monotherapy with an EGFR inhibitor except as maintenance therapy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Docetaxel and placebo<br>patients to receive backbone chemotherapy and placebo | Drug: docetaxel<br>* intravenous chemotherapy drug<br>Drug: placebo<br>* oral placebo<br>|
| Experimental: Docetaxel and Nintedanib<br>patients to receive backbone chemotherapy and nintedanib | Drug: docetaxel<br>* intravenous chemotherapy drug<br>Drug: nintedanib<br>* oral experimental therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1 | This outcome measure presents the number of patients with disease control according to RECIST, version 1.1, defined as number of patients with Complete response, partial response or stable disease. | Up to 6 months. |
A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
This is a Phase 3, randomised, active controlled, multicentre extension study to investigate the long-term safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. This is an extension study to PA-CL-05A (NCT01324128), subjects have already been enrolled and have been treated with study medication for at least 24 weeks.

Official Title
-----------------
An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Phase 3 Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21 Compared With Sevelamer Carbonate in Dialysis Patients With Hyperphosphataemia. Extension Study for Protocol PA-CL-05A (NCT01324128)

Conditions
-----------------
Chronic Kidney Disease Requiring Chronic Dialysis

Intervention / Treatment
-----------------
* Drug: PA21 (2.5 g tablet containing 500 mg iron)
* Drug: Sevelamer carbonate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have completed treatment in Protocol PA-CL-05A Written Informed Consent Exclusion Criteria: Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH) Other significant medical conditions Pregnancy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PA21<br> | Drug: PA21 (2.5 g tablet containing 500 mg iron)<br>* Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).<br>|
| Active Comparator: Sevelamer carbonate<br> | Drug: Sevelamer carbonate<br>* Film coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline and Levels at Each Time Point for Serum Phosphorus | Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing. | Every 4 weeks from baseline to Week 28 | 
| Change From Baseline and Levels at Each Time Point for Serum Calcium | Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing. | Every 4 weeks from baseline to Week 28 | 
| Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH) | Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing. | Every 4 weeks from baseline to Week 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PA21, Phosphate Binder
Effects of Spinal Cord Injury on Female Sexual Response

Study Overview
=================
Brief Summary
-----------------
The long term aims of this project are to 1) Understand the effect of varying degrees and levels of SCI and dysfunction(SCI/D)on females sexual response: 2) Identify the specific neuronal pathways involved in female sexual responses; and 3) Develop and evaluate new assessment and treatment methods for neurogenic sexual dysfunction in women.

Official Title
-----------------
Effects of SCI on Female Sexual Response

Conditions
-----------------
Female Sexual Dysfunction, Multiple Sclerosis, Spinal Cord Injury

Intervention / Treatment
-----------------
* Procedure: Sympathetic manipulation on sexual arousal in women


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MS or SCI Normal menstrual periods Normal hand function Have ability to feel sensation from lower abdomen to upper thigh region. Exclusion Criteria: Pregnant Menopausal

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Sympathetic manipulation on sexual arousal in women|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Our central hypothesis are: |  |  | 
| 1) In females the SNS regulates psychogenic genital vasocongestion 2) In females the orgasmic reflex requires the presence of an intact sacral spinal cord, 3) In females a pattern generator is responsible for the orgasmic reflex. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sexual response, sexual dysfunction in females, spinal cord injury
Preoperative Education

Study Overview
=================
Brief Summary
-----------------
The investigators will evaluate the effect of preoperative education on postoperative opioid.

Detailed Description
-----------------
The investigators propose a randomized trial to be performed at the Cleveland Clinic. Patients will be assigned to: 1) an educational video focused on postoperative analgesia modalities, opioids, and realistic pain expectations (analgesic education); or, 2) an educational video focused on other aspects of the perioperative experience.

Official Title
-----------------
The Effect of Preoperative Education

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Other: Video on analgesic education
* Other: Video on general perioperative education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Modified informed consent Adults ≥18 years American Society of Anaesthesiologists physical status 1-4 Scheduled for hip arthroplasty, laparoscopy assisted colorectal surgery Personal visit the PACE clinic Anticipated overnight postoperative hospitalization Reasonable English fluency Exclusion Criteria: Opioid use for more than 30 consecutive days within three preoperative months, at a daily dose of 15 mg or more of morphine or equivalent Regional block or epidural analgesia

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Analgesic education<br> | Other: Video on analgesic education<br>* A four minute video informing the patient about opioids.<br>|
| Placebo Comparator: General perioperative education<br> | Other: Video on general perioperative education<br>* A four minute video informing the patient about general perioperative process.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | Opioid consumption during the initial 72 hours after surgery. | 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Pain scores documented in PACU | every 15 minutes | 
| Pain Score | Pain scores documented on surgical floor | every 4 hours | 
| Satisfaction with post operative pain management | Using Likert scale 0-10 with 0 means not satisfied and 10 completely satisfied | 3 days post surgery |
Study of Acceptability of a New Distance-learning Tool MyFIT

Study Overview
=================
Brief Summary
-----------------
The investigators developed an on-line learning tool MyFIT enabling to patients with T1D to acquire the knowledge and skills for practicing functional insulin therapy from their home. The aim of the present study is to evaluate the acceptability of this new learning modality via the tool MyFIT by the patients and by the health professionnals.

Official Title
-----------------
Study of the Acceptability of a New Distance-learning Tool for Functional Insulin Therapy MyFIT by Patients With Type 1 Diabetes (T1D) and by Healthcare Professionals

Conditions
-----------------
Type1diabetes

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type one diabetes on intensified insulin therapy Exclusion Criteria: Hearing loss Visual problems

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 |
| --- | --- |
| Patients with type 1 diabetes<br> | Other: Survey<br>* Survey via questionnaire<br>|
| Health professionals<br> | Other: Survey<br>* Survey via questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate | score of the formation (80% correct answers) | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction measured by auto-questionnaire | calculation of total score of the answers on 6-point likert scale (minimum value = 0; maximum value = 100% , higher scores mean a better outcome) | 2 months |
Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects

Study Overview
=================
Brief Summary
-----------------
primary endpoint of this Study is maintenance of at least good clinical status for a period of 10 years following initial implantation among Cormet procedures enrolled inthe pre-market IDE.

Detailed Description
-----------------
Maintaining at least good clinical status will be determined based upon the composite clinical success (CCS) criterion which includes no revision, removal, or replacement of any device component and a Harris Hip Total score of greater or equal to 80 points.

Official Title
-----------------
Cormet Resurfacing Hip System Post PMA Approval Study (PMA #P050016)Pre-market (IDE) Study Group 10 Year Follow-Up With Metal Ion and Renal Function Data Collection Clinical Investigation Plan

Conditions
-----------------
Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Device: Cormet Hip Resurfacing System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects enrolled in the Cormet IDE study at the 5 identified clinical sites Individuals who agree to participate in the study by signing the informed patient consent form Exclusion Criteria: none
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>IDE subjects who received the Cormet Hip Resurfacing device | Device: Cormet Hip Resurfacing System<br>* Cormet Hip Resurfacing System<br>* Other names: Corin Cormet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to monitor the clinical performance of the Cormet implant system for a period of up to 10 years postoperative in order to confirm that there are no unexpected reductions in device performance following PMA approval |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score components including total score, pain, function and range of motion |  | 10 years | 
| device survival |  | 10 years | 
| device related adverse events |  | 10 years | 
| radiographic evaluation including radiolucencies, component migration, and femoral subsidence and tilt |  | 10 years | 
| whole blood trace metals and renal function |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip resurfacing, osteoarthritis, avascular necrosis, rheumatoid arthritis
Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with COPD.

Official Title
-----------------
A 24 Week, Placebo-Controlled, Randomized, Parallel Group Study Comparing Roflumilast 500 mcg Daily vs Placebo on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, COPD

Intervention / Treatment
-----------------
* Drug: Roflumilast


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Clinical diagnosis of COPD (Chronic Obstructive Pulmonary Disease) Currently stable COPD with no change in COPD treatment in the prior 4 weeks Main Exclusion Criteria: Clinical diagnosis of asthma Poorly controlled COPD Regular need for daily oxygen therapy

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: Roflumilast|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exacerbation rate |  |  | 
| quality of life |  |  | 
| symptoms |  |  | 
| use of rescue medication |  |  | 
| safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Roflumilast, Chronic Obstructive Pulmonary Disease, COPD