linjc16/ctgov huggingface dataset:
Remote Hearing Aid Adjustment for Experienced Hearing Aid Users

Study Overview
=================
Brief Summary
-----------------
Many hearing aid users experience substantial communication difficulties that may affect their participation in daily life situations negatively. One of the reasons for experiencing remaining problems could be due to unrealistic expectations, another reason could be that the hearing aid is not well adjusted or that the hearing aid user didn't got sufficient support and follow-up from the audiologist. The purpose of this project is to offer remote hearing aid adjustment as an additional support for experienced hearing aid users.

Official Title
-----------------
Remote Hearing Aid Adjustment for Experienced Hearing Aid Users; a Randomised Controlled Trial

Conditions
-----------------
Hearing Aids

Intervention / Treatment
-----------------
* Device: Remote hearing aid adjustment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 yr of age experienced hearing aid user Exclusion Criteria: <18 yr of age new hearing aid users

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Remote hearing aid adjustment. All participants in this group are offered hearing aids possible to adjust remotely. | Device: Remote hearing aid adjustment<br>* The intervention group is offered remote hearing aid adjustment whilst the control group is offered traditional hearing aid adjustment the requires physical appointments at the clinic. Remote hearing aid adjustment is applicable through mobile applications that hearing aid users download to their mobile phones.<br>|
| No Intervention: Control group<br>Traditional hearing aid adjustment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing Handicap Inventory for the Elderly/Adults (HHIE/A) | Assessing emotional and social outcomes of a hearing loss; minimum 0 points to maximum 100 points, a higher score means worse outcome. | Change is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Abbreviated Profile of Hearing Aid Benefit (APHAB) | Measures subjective hearing loss in four typical hearing situations; minimum | Change is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post |
Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Specific Aim 1: To determine total serum bilirubin (TSB) and unbound bilirubin (Bf) levels in term and late preterm infants during the first week of life. Specific Aim 2: Measure Bf levels in breast fed and formula fed infants and examine their relationship to unbound fatty acid (FFAu) levels. Specific Aim 3: To demonstrate that phototherapy results in different changes in TSB and Bf.

Official Title
-----------------
Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants

Conditions
-----------------
Neonatal Jaundice

Intervention / Treatment
-----------------
* Other: Assessment of unbound bilirubin levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term and late-preterm infants admitted to the regular care nursery of Robert Wood Johnson University Hospital will be eligible for the study Exclusion Criteria: Infants suffering from genetic, chromosomal or surgical conditions will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 6 Hours
Maximum Age: 7 Days

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast fed cohort<br> | Other: Assessment of unbound bilirubin levels<br>* Collection of residual blood for measurement of unbound bilirubin<br>|
| Formula fed cohort<br> | Other: Assessment of unbound bilirubin levels<br>* Collection of residual blood for measurement of unbound bilirubin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unbound bilirubin levels in term and late preterm infants |  | Two years | 
| Unbound bilirubin levels in breast-fed versus formula-fed term and late preterm infants |  | Two years | 
| Effect of phototherapy on unbound bilirubin levels |  | Two years |
Preventing Infections in Orthopaedic Patients

Study Overview
=================
Brief Summary
-----------------
Determine if antibiotic prophylaxis with intravenous cephalosporin and aminoglycoside in patients with Type II and II open fractures is safe and effective.

Detailed Description
-----------------
Determine the safety and efficacy of antibiotic prophylaxis in type II and II open fractures when using IV Cephalosporin and aminoglycoside. Identify the incidence of acute kidney injury. Identify the type and number of associated infections Identify the antibiotic resistance profile noted Identify any secondary infections at sites other than the fracture site

Official Title
-----------------
Antibiotic Prophylaxis for Type II and III Open Fractures: a Retrospective Chart Review

Conditions
-----------------
Open Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female >= 18 years old Patients are diagnosed with a Type II or III open fracture Exclusion Criteria: Prior to treatment, report of an allergy to beta-lactam or aminoglycoside antibiotics pregnancy did not receive 72 hours of IV antibiotic prophylaxis with 1st or 2nd generation cephalosporin and either gentamicin or tobramycin receiving ongoing inpatient care

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of fracture site infections | number of infections | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute renal injury | number of patients with worsening renal function from baseline | 30 days | 
| type of bacteria infection | name of bacteria infection | 30 days | 
| resistance trend in patients with infections | describe the number of MDRO infections | 30 days | 
| number of secondary infections at site other than fracture sites | describe the number infections at secondary sites | 30 days |
A Self-help Book for Insomnia Compared With Sleep Hygiene Advice in Patients Using Sleep Medications

Study Overview
=================
Brief Summary
-----------------
The aim is to assess whether a self-help book for insomnia will improve sleep and reduce hypnotic use among patients on sleep medications.

Detailed Description
-----------------
This study is a randomized controlled trial evaluating the effect of a self-help book for insomnia compared to the effect of sleep hygiene advice in patients using sleep medications. 150 patients will be randomized to receive either the book (75 patients) or the sleep hygiene advice (75 patients). Patients will fill questionnaires about sleep and health problems at baseline and after 3-6 months after receiving the written material. The main aims are to assess whether a self-help book is more effective in reducing sleep medication use and sleep problems.

Official Title
-----------------
A Randomized Controlled Trial Comparing a Self-help Book Focusing on Cognitive Behavioral Therapy for Insomnia With Standard Sleep Hygiene Advice Among Patients Using Hypnotics

Conditions
-----------------
Hypnotic; Sleep Disorder

Intervention / Treatment
-----------------
* Other: self-help book
* Other: sleep hygiene advice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Use of sleep medications on prescription or OTC during the last 6 months Exclusion Criteria: - Below 18 years of age

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-help book<br>A self-help book for insomnia (written in Norwegian) | Other: self-help book<br>* information and advice given in the self-help book<br>|
| Active Comparator: Sleep hygiene advice<br>A sheet of paper with standard sleep hygiene advice | Other: sleep hygiene advice<br>* information and advice given on the sheet of paper with sleep hygiene<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of hypnotics assessed as days per week | Self-reported sleep medication use (days of use per week,0-7) | 3-6 months | 
| Insomnia severity assessed with Insomnia Severity Index | Self-reported sleep problems on the validated Insomnia Severity Index (0-28), with higher scores indicating worse sleep | 3-6 months | 
| Insomnia severity assessed with Bergen Insomnia Scale | Self-reported sleep problems on the validated Bergen Insomnia Scale (0-42), with higher scores indicating worse sleep | 3-6 months |
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with non small cell lung cancer who have already received one platinum based chemotherapy.

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
Phase II Open-label Study to Investigate the Efficacy and Safety of PTK787/ZK 222584 Orally Administered Once Daily or Twice Daily at 1250 mg as Second-line Monotherapy in Patients With Stage IIIB or Stage IV Non-small-cell Lung Cancer (NSCLC)

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

Intervention / Treatment
-----------------
* Drug: SH T00268C
* Drug: PTK787/ ZK 222584


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non small cell lung cancer, Stage IIIB or Stage IV One and only 1 prior platinum-based chemotherapy No other uncontrolled concurrent illness Use of highly effective birth control methods in males or females with reproductive potential Exclusion Criteria: Previous participation in another trial within the last 4 weeks Surgery within 10 days prior to the start of study treatment Brain metastases Confirmed diagnosis of infection with the human immunodeficiency virus (HIV) Current treatment with warfarin sodium (Coumadin) or similar anticoagulation medication Breast feeding

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: Arm 1<br> | Drug: SH T00268C<br>* 1250 mg experimental drug od<br>|
| Experimental: Arm 2<br> | Drug: PTK787/ ZK 222584<br>* 1250 mg experimental drug bid (500mg + 750mg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response rate (complete or partial response according to RECIST). |  | At baseline and every 8 weeks afterwards | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression. |  | At baseline and every 8 weeks afterwards |
Impacts of Stoppa and Total Extraperitoneal Inguinal Hernia Repair on the Lower Extremity Muscular Functions

Study Overview
=================
Brief Summary
-----------------
Comparison of physical activity parameters of the lower extremity muscles in patients who received total extraperitoneal repair (TEP) and STOPPA repair.

Detailed Description
-----------------
The patients were evaluated during the preoperative period and in the postoperative day 3, to achieve an isometric and isokinetic, objective assessment of the pain-related lower extremity muscular function changes.

Official Title
-----------------
Quantitative Assessment of the Impacts of Stoppa Repair and Total Extraperitoneal Repair on the Lower Extremity Muscular Functions in Cases of Unilateral Inguinal Hernia; a Randomized Controlled Study

Conditions
-----------------
Hernia, Inguinal

Intervention / Treatment
-----------------
* Procedure: Stoppa inguinal hernia repair
* Procedure: Total extraperitoneal inguinal hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral inguinal hernia Exclusion Criteria: Contralateral hernia repair history Recurrent inguinal hernia Incarceration or strangulation Bilateral inguinal hernia Severe congestive heart failure Severe hypertension Rheumatoid arthritis Systemic or neurologic diseases altering lower extremity functions

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: Stoppa repair<br>Stoppa inguinal hernia repair | Procedure: Stoppa inguinal hernia repair<br>* Stoppa inguinal hernia repair<br>|
| Experimental: TEP repair<br>Total extraperitoneal inguinal hernia repair | Procedure: Total extraperitoneal inguinal hernia repair<br>* Total extraperitoneal inguinal hernia repair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional loss in lower extremity muscles | Physical activity parameters (isokinetic and isometric values) of the lower extremity muscular functions were measured with a dynamometer. | postoperative day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospital stay |  | From time of admission to time of discharge an approximate length of three days | 
| Postoperative pain score | Visual analog score assessment of post operative pain | Postoperative 12 hour | 
| Recurrence rate | Number of patients with recurrence | Postoperative 4 months | 
| Complications | Complications like infection, seroma, hematoma, abscess, wound healing problems and urinary retension. | Postoperative 1 month |
Study of Ticilimumab in Patients With Metastatic Colorectal Cancer Whose Disease Had Progressed After Treatment

Study Overview
=================
Brief Summary
-----------------
This study is for patients with metastatic adenocarcinoma arising from the colon or rectum who have received treatment(s) for metastatic disease with subsequent disease progression. Patients who are intolerant to treatment(s) are also included. This is a study for good performance status colorectal cancer patients who have exhausted standard therapy options.

Official Title
-----------------
Phase 2, Single Arm Study Of Ticilimumab In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Drug: CP-675,206


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radiographic evidence of metastatic, progressive disease following standard therapies. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Exclusion Criteria: Known brain metastases or uncontrolled pleural effusions. History of chronic inflammatory or autoimmune disease.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>single arm | Drug: CP-675,206<br>* 15 mg/kg IV q 3 months for 4 cycles in the absence of disease progression or unacceptable toxicity.<br>* Other names: ticilimumab, tremelimumab;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the best overall response rate per RECIST (BRR) in patients with metastatic adenocarcinoma of the colon or rectum treated with CP-675,206 . |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of CP-675,206 in this population. |  | 18 mos | 
| To identify any human anti human antibody (HAHA) response to CP-675,206 . |  | 3 yrs | 
| To identify potential relationships between polymorphisms in the Cytotoxic T lymphocyte-associated antigen 4 (CTLA4), Fcgamma receptor IIa (FcgRIIa), IgG2a genes with safety and/or immune response of patients treated with CP-675,206. |  | 3 yrs | 
| To assess additional evidence of anti-tumor activity as measured by duration of response, progression-free survival and overall survival. |  | 2 yrs | 
| To obtain pharmacokinetic (PK) data to be evaluated in a future meta analysis of CP-675,206 pharmacokinetics. |  | 3 yrs |
Long-term Surival of GIST Patients ≥ 10 Years on Imatinib

Study Overview
=================
Brief Summary
-----------------
This is a cross-sectional cohort study of metastatic GastroIntestinal Stromal Tumor (GIST) patients on imatinib for ≥ 10 years included in EORTC trial 62005-STBSG entitled Phase 3 randomized, intergroup, international tiral assessing the clinical activity of STI-571 at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) expressing the KIT receptor tyrosine kinase (CD117) - NCT00685828. With this study, the aim is to identify patient characteristics, tumour characteristics, treatment factors and quality of life outcomes associated with prolonged treatment with imatinib and/or prolonged survival. This observational study will further help to put in place a questionnaire to evaluate patients quality of life with prolonged imatinib treatment, that will then be used in a prospective study.

Official Title
-----------------
Long-term Survival of Advanced/Metastatic GIST Patients Responding to Imatinib Treatment: an Observational Follow-up Study

Conditions
-----------------
GIST

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients included in the EORTC 62005 trial: Adult patients with metastasized GIST Patients who have been treated with imatinib for ten years or longer For the identified patients who are still alive: Able to read and answer questionnaires Able to provide written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 28 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 |
| --- | --- |
| Study 62005-STBSG patients treated with imatinib > 10 years<br> | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient characteristics | Age at time of randomization, gender, medical history and previous treatment(s) | At time of registration | 
| Tumour characteristics | Stage of the disease, tumor grade, tumor location and molecular features of primary tumor | At time of registration | 
| Duration of imatinib treatment | Time on imatinib treatment from start untill definitive discontinuation of imatinib treatment | At time of registration | 
| Health releated quality of life | QLQ-C30 | At time of registration | 
| Overall survival | From time of randomization to the date of death, whatever the cause | At time of registration |