linjc16/ctgov huggingface dataset:
Evaluation of Nebulization and Positive Expiratory Pressure Combination

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficiency of nebulization and positive expiratory pressure combination

Conditions
-----------------
Cystic Fibrosis, Healthy Subjects

Intervention / Treatment
-----------------
* Device: Positive expiratory pressure
* Drug: amikacine nebulization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable cystic fibrosis patients older than 16 y.o. Healthy subjects Exclusion Criteria: Kidney failure No pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebulization combined to positive expiratory pressure<br>Experimental arm | Device: Positive expiratory pressure<br> <br> Drug: amikacine nebulization<br> <br> |
| Active Comparator: Nebulization<br>Control arm | Drug: amikacine nebulization<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary excretion of amikacin | Pharmacokinetic study of the urinary excretion of amikacin after nebulization | 24 hours after the nebulization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breathing pattern | recoding of frequency and tidal volume during the nebulization | participants will be recorded for the duration of the nebulization, an expected average of 15 minutes |
Visual Prognosis in Non-Penetrating Corneal Blast Injuries

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess visual quality of patients with non-penetrating, non-metallic, stable corneal foreign bodies. Visual quality will be assessed by examining visual acuity, wavefront analysis and contrast sensitivity. Drawings, photographs, and confocal microscopy will be used to document clinical examination of the cornea at baseline and on follow-up examinations.

Official Title
-----------------
Visual Prognosis in Non-Penetrating Corneal Blast Injuries

Conditions
-----------------
Corneal Foreign Body Following Blast Injury

Intervention / Treatment
-----------------
* Behavioral: Visual quality of patients with corneal eye injuries


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Access to medical care at Walter Reed Army Medical Center Age 18 years or older Corneal foreign bodies from blast injuries Available for evaluation at Walter Reed Exclusion Criteria: Residual, recurrent or active ocular disease in the designated eye as determined by exam and history. Penetrating ocular trauma or injury to the posterior segment Prior history of ocular surgery Any physical or mental impairment that would preclude participation in any of the examinations. Any ocular abnormality other than corneal foreign bodies that have any impact on vision (i.e. other abnormalities from trauma such as retinal detachment, corneal laceration, traumatic cataract, or abnormalities unrelated to trauma such as herpes.

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

| Intervention/Treatment |
| --- |
|Behavioral: Visual quality of patients with corneal eye injuries|Visual quality of patients with corneal eye injuries|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Food Composition and Palatability

Study Overview
=================
Brief Summary
-----------------
This study will investigate fat taste and if free fatty acids (FFA) in food function as a signal for fat content. FFA are quite unpleasant - the investigators want to measure if the concentration in different foods correlates with hedonic preference. FFA concentration from a variety of foods will be used to determine if people who have greater sensitivity for FFA find foods with higher FFA concentrations less acceptable. Further, this study with determine whether the relationship between fat taste and hedonic food preference is modified by sex and body mass index (BMI).

Official Title
-----------------
Food Composition and Palatability

Conditions
-----------------
Fat Taste

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-64 Healthy Non-smoker Exclusion Criteria: Food allergies Inability to detect and identify basic tastes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| Taste and hedonic ratings of NEFA<br>Linoleic acid solutions from 0.005% to 1.58%. Participants swish and spit 10 - 7.5mL solutions. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NEFA sensitivity (Participants will taste and rate 10 solutions based on intensity) | Participants will taste and rate 10 solutions based on intensity | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food consumption and preference (Participants will answer questions regarding consumption of foods and preference) | Participants will answer questions regarding consumption of foods and preference. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fat taste, food preference, consumption, free fatty acids
Secured Internet-mediated Psychotherapy With Psychiatry Patients

Study Overview
=================
Brief Summary
-----------------
This is the second phase (Phase B) of the main project Bank for Thoughts, which has the following aims: Improvement of software for secured (encrypted and access-controlled) asynchronous text-based communication within health services. (Adjustments for use in psychiatry.) Open clinical trials with Internet-mediated psychotherapy or counselling in out-patient child and adolescent psychiatry. Development of indications and precautions for text-based Internet-mediated psychotherapy.

Detailed Description
-----------------
This phase (Phase B) concentrates on qualitative evaluation of open clinical single case trials using asynchronous Internet-mediated text-dialogue for psychotherapeutic purposes. Single patients in differing treatment phases, conditions, age and sex categories are interviewed after using Internet-contact as a supplementary tool in psychotherapy. Their therapists are interviewed as well. The purpose is systematically gathering single-case experiences with the tool, to build a hypothesis for research and preliminary guidelines for experimental clinical use of Internet-mediated psychotherapy.

Official Title
-----------------
Secured Internet-mediated Psychotherapy With Psychiatry Patients. Software Improvement, Clinical Trials and Development of Clinical Precautions

Conditions
-----------------
Psychiatric Disorders

Intervention / Treatment
-----------------
* Device: eTherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Motivation for e-mail contact Therapist evaluation for suitability Exclusion Criteria: Paranoia Psychosis Eating disorders Addictive problems Denying or concealing symptoms

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 30 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: eTherapy|secured e-mail system between patient and therapist|

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
-----------------
eTherapy supplementary
Role of Psychiatric Profile in Prehabituated Patients After Vestibular Schwannoma Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess effect of psychiatric profile on visual sensitivity and overall health status in patients who underwent surgery for vestibular schwannoma and were prehabituated by chemical vestibular ablation.

Official Title
-----------------
Assessment of Visual Sensitivity, Psychiatric Profile and Quality of Life Following Vestibular Schwannoma Surgery in Patients Prehabituated by Chemical Vestibular Ablation

Conditions
-----------------
Vestibular Schwannoma, Vestibular Function Disorder

Intervention / Treatment
-----------------
* Procedure: intratympanic application of gentamicin
* Procedure: microsurgical removal of vestibular schwannoma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T3, T4 vestibular schwannoma recorded growth of a tumour hearing loss greater than 50% in PTA Exclusion Criteria: T1 vestibular schwannomas no growth progression normal hearing

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
Interventional Model Description: two groups of patients, one group prehabituated by chemical labyrintectomy, the second control group without prehabituation before the surgery
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITG (intratympanic gentamicin) group<br>Patients who underwent prehabituation by gentamicin prior to surgery for vestibular schwannoma. They underwent intratympanic application of gentamicin and microsurgical removal of vest. schwannoma. | Procedure: intratympanic application of gentamicin<br>* under local anesthesia is gentamicin instilled through tympanic membrane to tympanic cavity<br>Procedure: microsurgical removal of vestibular schwannoma<br>* surgery under general anesthesia<br>|
| Active Comparator: control group<br>patients without prehabituation before surgery. They underwent microsurgical removal of vest. schwannoma. | Procedure: microsurgical removal of vestibular schwannoma<br>* surgery under general anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of optokinetic nystagmus measurement | During electronystagmography gain of optokinetic nystagmus is measured before and after the intervention | change of the gain of optokinetic nystagmus among 3 time points is measured: before intervention, 1 week after intervention, 3 months after intervention |
Circulating Tumour DNA (ctDNA) as a Prognostic and Predictive Marker in Colorectal Cancer - a Pilot Study

Study Overview
=================
Brief Summary
-----------------
In clinical practice, there are currently no biomarkers that can guide colorectal cancer treatment in the primary and curative setting. Improved biomarker-based adjuvant treatments would be of greatest value in order to reduce the risk of relapse. There are reasons to believe that measurements of circulating tumor DNA (ctDNA) in plasma could be used to monitor minimal residual disease after surgery. To address this question, a pilot study was conducted with the purpose to demonstrate the feasibility to perform prospective profiling of ctDNA in a cohort of patients with colorectal cancer stage I-III using the already created Nordic infrastructure for clinical research built up for the ALASCCA trial. If the pilot study proves successful, a large randomised controlled Nordic multicenter study is planned where patients with positive ctDNA 4-6 weeks after radical surgery will be randomised to chemotherapy and/or a biologic agent.

Official Title
-----------------
A Pilot Study Investigating the Feasibility to Perform Prospective Circulating Tumor DNA (ctDNA) Profiling in Patients With Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colon or rectal cancer tumor stage I-III planned for radical surgery Clean Colonoscopy or Computed Tomography (CT) colon within 3 months preoperatively or postoperatively but before randomization Patient able to understand and sign written informed consent Exclusion Criteria: Distant metastases Other cancers (excluding colorectal cancer or other skin cancer than melanoma) within 3 years from screening Significant medical illness that would interfere with study participation Pregnancy or breastfeeding females Current participation in another clinical trial that will be in conflict with the present study Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and logistics of measuring ctDNA |  | 2 years | 
| Frequency of positive ctDNA postoperatively in relation to tumour stage and oncological outcome. |  | 3 years | 
| Frequency of positive ctDNA preoperative converted to negative postoperatively. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ctDNA, predictive marker, prognostic marker, colon cancer, rectal cancer
Loop Resectoscope in Treating Patients With Bladder Cancer or Benign Prostatic Hyperplasia Who Are Undergoing Transurethral Resection

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Transurethral resection is a less invasive type of surgery for bladder cancer or benign prostatic hyperplasia. Transurethral resection using a loop resectoscope may have fewer side effects and improve recovery. PURPOSE: This clinical trial is studying how well the loop resectoscope works in treating patients with bladder cancer or benign prostatic hyperplasia who are undergoing transurethral resection.

Detailed Description
-----------------
OBJECTIVES: Determine the efficacy, in terms of mechanical capabilities, of the Roei loop resectoscope in patients with bladder cancer or benign prostatic hyperplasia undergoing transurethral resection of bladder tumor or benign prostatic adenoma. Determine the quality of specimens submitted for histological analysis from patients undergoing this procedure. OUTLINE: This is an open-label, pilot study. Patients undergo transurethral resection using the Roei loop resectoscope. Surgeon satisfaction with the Roei loop resectoscope is measured by a self-assessment questionnaire. The quality of specimens submitted for histological study are also assessed. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Official Title
-----------------
Quality Assessment of the Roei Loop Resectoscope for Transurethral Resection of Bladder Neoplasm and BPH

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Procedure: biopsy
* Procedure: therapeutic conventional surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of bladder cancer or benign prostatic hyperplasia PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
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 |
| --- |
|Procedure: biopsy|nan|
|Procedure: therapeutic conventional surgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon satisfaction with usage of Roei loop resectoscope measured by a questionnaire after the surgical procedure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent bladder cancer, stage I bladder cancer, stage II bladder cancer, stage III bladder cancer, stage IV bladder cancer
An Extension Study Administering YM155 to Subjects Previously Enrolled in Another Protocol Administering YM155

Study Overview
=================
Brief Summary
-----------------
This protocol is open to subjects previously enrolled in and who had completed a Phase I or Phase II study administering YM155. Subjects who are receiving benefit from treatment with YM155 are eligible after completing the previous study.

Detailed Description
-----------------
The main objective of the study is to continue to evaluate the safety and efficacy of YM155. Each subject will be treated at the dose he/she was receiving at the completion of his/her previous phase I or phase II YM155 study.

Official Title
-----------------
Phase II: An Open-Label Extension Study of 168-Hour Continuous Infusion of YM155 in Subjects Previously Enrolled in a Phase I or Phase II Protocol Administering YM155

Conditions
-----------------
Prostate Cancer, Melanoma, Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: YM155


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed a Phase I or II YM155 study with at least stable disease and continues to meet the criteria as stated in the previous YM155 study that allows for additional treatment with YM155 Lack of progression based on the most recent radiological imaging, biochemical assessments and/or physical examination Negative pregnancy test result (females of child-bearing potential) Exclusion Criteria: More than 21 days (or 14 days depending on the study of origin) between the time the last infusion of YM155 was stopped in the previous study and the proposed start of the first infusion in this study

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. YM155<br> | Drug: YM155<br>* continuous infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Response Rate |  | End of Study up to 77 months | 
| Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs) |  | End of Study up to 77 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, melanoma, lymphoma, YM155
Efficacy and Safety of Piracetam Taken for 12 Months in Subjects Suffering From Mild Cognitive Impairment (MCI)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to explore in a more documented way the relative potential and efficacy of piracetam 9600 and 4800 mg daily.

Official Title
-----------------
A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of 9600 and 4800 mg/Day Piracetam Taken for 12 Months by Subjects Suffering From Mild Cognitive Impairment (MCI)

Conditions
-----------------
Memory Disorders

Intervention / Treatment
-----------------
* Drug: Piracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male/female between 50 and 89 years (inclusive) declining cognitive function of at least 3 months duration interfering with complex activities of daily living normal basic activities of daily independent living Clinical Dementia Rating scale score equal to 0.5 score at least one point above the lowest possible score on 7 out of 8 tests in the cognitive battery at both Selection Visit and Baseline Visit Exclusion Criteria: general anesthetics within 3 months of selection visit history of severe allergic drug reaction(s) history of drug or alcohol dependence (DSM IV defined) within the last 12 months any drug prescribed to activate cerebral metabolism, taken within 1 week of screening or/and concomitantly concomitant intake of anticoagulent medications concomitant intake or intake within 1 week before screening of drug that might affect cognitive function or central nervous system history of dementia, psychiatric or neurological disorders, mental retardation, learning disabilities and stroke current depression impaired renal function, thyroid function or neurological degeneration any gastrointestinal dysfunction that might interfere with the absorption or elimination of the study drug insulin-dependant diabetes mellitus bleeding disorders or disturbance in hemostatic function.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 89 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: Piracetam|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Battery Composite Score over a 52-week period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of piracetam for 12 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Piracetam, Nootropil