linjc16/ctgov huggingface dataset:
Adult Dacryocystocele Among Patients With Epiphora

Study Overview
=================
Brief Summary
-----------------
Patients with lacrimal dacryocystocele were chosen for the study. Dacryocystorhinostomy were done for them after their evaluation.

Detailed Description
-----------------
Evaluation for lacrimal passage in the included patients using syringing, probing and dye disappearance test. Dacryocystorhinostomy were done for all patients and followed up for at least 6 months.

Official Title
-----------------
Adult Encysted Dacryocystocele: Prevalence Among Patients With Epiphora and Its Management

Conditions
-----------------
Lacrimal Passage Obstruction

Intervention / Treatment
-----------------
* Procedure: Dacryocystorhinostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lacrimal sac mucocele Acquired type Exclusion Criteria: No previous lacrimal sac surgery Suspected lacrimal sac malignancy

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Adult Dacryocystocele
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lacrimal sac mucocele<br>Adult patients with lacrimal sac mucocele | Procedure: Dacryocystorhinostomy<br>* Anastomosis between lacrimal sac and nasal cavity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency of the lacrimal passage | Disappearance of the watering of the eye reported by the patients and by fluorescein disappearance test | 2 weeks | 
| Disappearance of lacrimal sac swelling | No evident swelling in the medial side of the eye | 1 month |
Rehabilitation in Chronic Obstructive Pulmonary Disease Outpatients

Study Overview
=================
Brief Summary
-----------------
A retrospective analysis on a cohort of unselected COPD patients admitted to pulmonary rehabilitation (PR) performed in one rehabilitation centre has shown that the usual program is feasible and effective even in the presence of complex comorbidities, although some combined diseases might reduce the overall proportion of patients who respond to pre-defined outcomes criteria (Crisafulli E, et al. Thorax 2008;63:487-92). The aim of this prospective study is to describe the pattern of prevalence of the most frequently associated COPD-comorbidities and the clinical impact on rehabilitation outcomes, referred to 3 teaching and 1 private hospitals admitting for pulmonary rehabilitation purposes.

Official Title
-----------------
Effectiveness of Rehabilitation in COPD Outpatients With Comorbidities

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of COPD as defined and classified according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines Ability to perform a rehabilitation program. Exclusion Criteria: Patients with asthma or any other pulmonary diseases (either obstructive or restrictive. Patients no able to complete a rehabilitation program

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Nr. patients with a minimum clinically important difference (MCID) in quality of life (change in St George's Respiratory Questionnaire) |  | T0 (admission in hospital) - Tend (discharge, after 20 days) | 
| Nr. patients with a minimum clinically important difference (MCID) in exercise tolerance (change in 6MWD) |  | T0 (admission in hospital) - Tend (discharge, after 20 days) | 
| Nr. patients with a minimum clinically important difference (MCID) in breathless (change in MRC scale) |  | T0 (admission in hospital) - Tend (discharge, after 20 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who withdrew from rehabilitation. |  | Tend (discharge, after 20 days) | 
| Prevalence of comorbidities associated to COPD |  | Tend (discharge, after 20 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD (Chronic Obstructive Pulmonary Disease), outpatients, rehabilitation, comorbidities, patient-centered outcome
Creatine Supplementation on Kidney Function in Resistance-trained Individuals

Study Overview
=================
Brief Summary
-----------------
There is a claim that creatine supplementation might affect kidney function, especially in those consuming a high-protein diet. The aim of this study was to investigate the effects of creatine supplementation on kidney function in resistance-trained individuals ingesting a high-protein diet.

Conditions
-----------------
Healthy Persons

Intervention / Treatment
-----------------
* Dietary Supplement: creatine
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participation in recreational resistance training consumption of a high-protein diet (≥ 1.2 g/Kg/d) Exclusion Criteria: vegetarian diet use of creatine supplements in the past 6 months chronic kidney disease use of anabolic steroids.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: creatine<br>20 g/d for 5 d followed by 5 g/d throughout the trial | Dietary Supplement: creatine<br>* 20 g/d for 5 d followed by 5 g/d throughout the trial<br>|
| Placebo Comparator: placebo (dextrose)<br>20 g/d for 5 d followed by 5 g/d throughout the trial | Dietary Supplement: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kidney function | as assessed by 51Cr-EDTA clearance | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proteinuria |  | 3 months | 
| albuminuria |  | 3 months | 
| serum urea |  | 3 months | 
| serum creatinine |  | 3 months |
Trial of Iressa in Prostate Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study is being carried out to see if ZD1839 is effective in treating prostate cancer after being diagnosed with an early rising PSA (prostate specific antigen) following surgery.

Official Title
-----------------
An Open-Label, Phase II Trial Of 250 mg ZD1839 (IRESSA™) In Prostate Cancer Patients With Early Biochemical Failure Post Prostatectomy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Gefitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Removal of prostate for prostate cancer Raised level of prostate specific antigen (PSA) post-surgery Can have received some radiation therapy Exclusion Criteria: Any after surgery male hormone blocking therapy. Low white blood cell count Abnormal liver function test

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gefitinib|250 mg tablet oral daily dose|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of the trial is to evaluate the activity of oral ZD1839 (250 mg once daily administered continuously) in subjects with early biochemical failure post prostatectomy by estimating the PSA response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the duration of PSA response |  |  | 
| To estimate the partial PSA response rate |  |  | 
| To estimate the change in the ratio of free PSA : total PSA at 6 and 12 months compared with baseline |  |  | 
| To investigate the change in PSA levels after discontinuation of ZD1839 |  |  |
Study to Evaluate the Effects of Age & Gender on PK, Safety & Tolerability of HCV-796 Administered to Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This study is an open-label, single-dose, parallel group study to evaluate the effects of age and gender on the pharmacokinetics, safety, and tolerability of HCV-796 administered orally to healthy subjects.

Official Title
-----------------
An Open-Label, Single-Dose, Parallel Group Study to Evaluate the Effects of Age and Gender on the Pharmacokinetics, Safety, and Tolerability of HCV-796 Administered Orally to Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: HCV-796


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Men or nonlactating and nonpregnant women, aged 18 to 45, and >65 years. Men must agree to practice barrier contraception for 12 weeks after the last test article administration. Estimated (calculated) creatinine clearance must be within the age-appropriate normal range. Exclusion: History of seizures. History of rhabdomyolysis. History of thyroid disease.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>HCV-796 1000mg single dose | Drug: HCV-796<br>* HCV-796 1000mg single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetic (PK) profile of HCV-796 in healthy men and women of different ages. |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of a single oral dose of HCV-796 in healthy men and women of different ages. |  | 15 days |
Retrospective Review of the Cook Biodesign® Fistula Plug to Treat Anorectal Fistulas

Study Overview
=================
Brief Summary
-----------------
The study is a retrospective review of the use of the Biodesign® Fistula Plug (C-FPS-[X]). A total of 73 patients will be enrolled who have had a fistula plug placed to treat anorectal fistulas and will therefore be eligible for statistical analysis.

Official Title
-----------------
A Retrospective Review of the Use of the Cook Biodesign® Fistula Plug (C-FPS-0.2, C-FPS-0.4, and C-FPS-0.7) to Treat Anorectal Fistulas

Conditions
-----------------
Anorectal Fistula

Intervention / Treatment
-----------------
* Device: Cook Biodesign® Fistula Plug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have had surgery to treat anorectal fistula where the Biodesign® Fistula Plug was placed during the procedure Exclusion Criteria: Patients not receiving the Biodesign® Fistula Plug for treatment of their anorectal fistula
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated for a anorectal fistula<br>Patients who were treated for a anorectal fistula with a Biodesign Fistula plug | Device: Cook Biodesign® Fistula Plug<br>* The Cook Biodesign® Fistula Plug is for implantation to reinforce soft tissue for repair of Anorectal fistulas.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of fistula closure | Absence of drainage from the external fistula opening with complete epithelialization of the external fistula opening upon clinical exam. | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fistula plug
Studying Genes in Samples From Younger Patients With Rhabdomyosarcoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and find biomarkers related to cancer. It may also help doctors find better ways to treat cancer. PURPOSE: This research trial studies genes in samples from younger patients with rhabdomyosarcoma.

Detailed Description
-----------------
OBJECTIVES: To obtain a larger cohort of rhabdomyosarcoma samples (alveolar and embryonal) to establish a more accurate estimate of the frequency of particular genetic lesions. To provide the statistical power to establish an unambiguous connection between focal genetic lesions, histological subtype, and outcome for patients with rhabdomyosarcoma. OUTLINE: DNA samples are analyzed in solid and liquid phase for exons of all genes mutated from previous discovery. DNA is then eluted and sequenced by illumina platform.

Official Title
-----------------
Study Recurrency Testing of Mutations Identified in WGS of Pediatric Rhabdomyosarcoma

Conditions
-----------------
Sarcoma

Intervention / Treatment
-----------------
* Genetic: mutation analysis
* Genetic: nucleic acid sequencing
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Matched genomic deoxyribonucleic acid (DNA) from tumor and germline samples from patients diagnosed with rhabdomyosarcoma (alveolar or embryonal) 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: mutation analysis|nan|
|Genetic: nucleic acid sequencing|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of particular genetic lesions |  |  | 
| Identification of mutations that occur in at least 5% of rhabdomyosarcomas as a whole |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alveolar childhood rhabdomyosarcoma, embryonal childhood rhabdomyosarcoma
Multisystem Shortness of Breath Evaluation Study

Study Overview
=================
Brief Summary
-----------------
The MUSE study is a prospective observational cohort study of patients referred to pulmonary and/or cardiology specialty clinic for evaluation of shortness of breath or dyspnea. Patients will undergo all pertinent testing and will be required to fill out a number of epidemiologic and quality of life related questionnaires. Follow up will continue for at least one year.

Official Title
-----------------
Multisystem Shortness of Breath Evaluation Study

Conditions
-----------------
Dyspnea

Intervention / Treatment
-----------------
* Diagnostic Test: Pulmonary function studies
* Diagnostic Test: Echocardiogram
* Diagnostic Test: Electrocardiogram
* Diagnostic Test: Chest radiography
* Diagnostic Test: Blood test
* Behavioral: Quality of life questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to Pulmonary and/or Cardiology clinic for the evaluation of unexplained dyspnea. Exclusion Criteria: Patients with a known cause of dyspnea such as established cardiopulmonary disease

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Pulmonary function studies|nan|
|Diagnostic Test: Echocardiogram|nan|
|Diagnostic Test: Electrocardiogram|nan|
|Diagnostic Test: Chest radiography|nan|
|Diagnostic Test: Blood test|nan|
|Behavioral: Quality of life questionnaire|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea etiology | All patients will undergo cardiopulmonary testing and will be offered quiestionnaires including the M3 online questionnaire | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Several questionnaires will be used including the M3 questionnaire | 6 months |
Evaluation of the Link Between Bladder Sensation and Changes in Skin Electrical Conductance and Heart Rate.

Study Overview
=================
Brief Summary
-----------------
Measuring sympathetic skin response or heart rate variability can provide an objective biomarker of bladder sensation and its modulation by drug with potential to treat overactive bladder.

Detailed Description
-----------------
Evaluation of the link between bladder sensation and changes in skin electrical conductance and heart rate.

Official Title
-----------------
Evaluation of Sympathetic Skin Responses and Heart Rate Variability as Objective Measures of Bladder Sensation - a Double Blind Third Party Open Placebo Controlled Randomised Study Using a Single Dose of Tolterodine in Patients With Idiopathic Overactive Bladder and Healthy Volunteers

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: Tolterodine
* Procedure: Filling cystometry
* Procedure: Intravesical neurostimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, healthy volunteers or OAB patients 18-65 years old, non pregnant and non lactating Exclusion Criteria: History of lower urinary tract pathology Excessive alcohol and tobacco consumption Treatment with investigational drug in the last 30 days Abnormal ECG trace Conditions that would contraindicate the use of tolterodine or any other anti muscarinic agent

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tolterodine<br> | Drug: Tolterodine<br>* Single dose per patient as determined by protocol.<br>Procedure: Filling cystometry<br>* This is a procedure.<br>Procedure: Intravesical neurostimulation<br>* This is a procedure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability evoked by filling cystometry and intravesical neurostimulation and sympathetic skin response evoked by intravesical neurostimulation in healthy volunteers and OAB patients |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the correlation between the changes in heart rate variability and sympathetic skin response evoked by filling cystometry and intravesical neurostimulation in OAB patients. |  | duration of study | 
| To determine whether there is a difference in the stimulus response relationship for the evoked changes in HRV and SSR between healthy volunteers and OAB patients. |  | duration of study |
How Shoes With Rocker Soles Affect Walking

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare how 3 special types of shoes with rocker-shaped soles help people with foot deformities to walk better. This study will use modern gait lab techniques to measure the forces on the bottom of the feet and to examine whether there is any effect higher on the leg from the rocker soles.

Detailed Description
-----------------
The rocker sole is the most commonly prescribed external shoe modification. Use of rocker soles has been based on theoretical considerations and empirical observations with minimal scientific study and validation. With the passage of the therapeutic shoe bill (PL-100-203, section 4072) authorizing Medicare coverage of shoes and shoe modifications for diabetics, it is important to have objective data regarding the effect of rocker soles. This cross-over study will randomize 46 subjects (40 sensate and 6 insensate) to a combination of 3 rocker soles. Patients will be evaluated at baseline and after 20 minutes wearing each rocker sole shoe design to determine the effect of the type of rocker sole on plantar pressure and gait.

Official Title
-----------------
Rocker Sole Kinetics and Kinematics

Conditions
-----------------
Diabetic Feet

Intervention / Treatment
-----------------
* Device: Shoes with Rocker Soles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals Insensate individuals Exclusion Criteria: History or physical findings of any trunk, back or lower extremity orthopedic or neurologic abnormalities Inability to walk Inability to follow verbal directions

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Shoes with Rocker Soles|nan|

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
-----------------
Pedorthics, Rocker sole, Plantar pressure, Diabetic feet, Insensate feet, gait analysis, Gait abnormalities