linjc16/ctgov huggingface dataset:
Safety of MK0928 on Insomnia in the Elderly (0928-005)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study the safety of MK0928 on insomnia in the elderly.

Detailed Description
-----------------
The duration of treatment is 1 year.

Official Title
-----------------
A 12-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel Groups, Multicenter Long-Term Safety Study of MK0928 in the Treatment of Elderly Outpatients With Primary Insomnia

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: MK0928, gaboxadol
* Drug: Comparator: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Insomnia

Ages Eligible for Study
-----------------
Minimum 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0928, gaboxadol|nan|
|Drug: Comparator: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability after 12 months of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discontinuation symptoms and rebound insomnia using sleep diary and Tyrer Withdrawal Symptom Questionnaire |  |  |
SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial Using HEMOPATCH

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in reducing the incidence and duration of air leaks after lung resection compared to standard techniques. Hypothesis: The routine application of HEMOPATCH Sealing Hemostat on the visceral pleura in lung resection areas, during lung resection procedures, is more EFFICIENT to reduce the incidence and duration of prolonged air leaks as compared to standard surgical measures.

Official Title
-----------------
Prospective Randomized Clinical Trial to Prevent Air Leaks After Lung Resection With Hemopatch™ Sealing Hemostat: SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial

Conditions
-----------------
LUNG DISEASES

Intervention / Treatment
-----------------
* Device: Hemopatch™ Sealing Hemostat
* Procedure: Standard surgical technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over the age of 18 years who are able to give their informed consent Patients undergoing lung resection surgery for either malignant or benign conditions including: Lobar and sublobar resections Open, video-assisted thoracoscopic or robotic surgeries Diagnostic or therapeutic procedures Exclusion Criteria: Traumatic pulmonary contusion or laceration Lung reduction surgery Planned removal of more than 10 lung lesions Pneumonectomy Known hypersensitivity to bovine protein Known hypersensitivity to Brilliant Blue FCF (E133) Presence of active infection

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemopatch™<br>Hemopatch™ sealing hemostat | Device: Hemopatch™ Sealing Hemostat<br>* Hemopatch™ application over lung resection areas<br>|
| Active Comparator: Control<br>Standard surgical technique | Procedure: Standard surgical technique<br>* Lung resuturing or restapling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of postoperative air leaks | Duration of postoperative lung air leaks expressed in hours | Within first 30 postoperative days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung surgery, air leak, prevention
Hypnosis as a Treatment of Chronic Widespread Pain in General Practice. A Pilot Study.

Study Overview
=================
Brief Summary
-----------------
Objective: The study was performed to evaluate the effect of a standardized hypnosis treatment used in general practice for patients with chronic widespread pain (CWP). Design: A randomized control group-controlled study. Setting and subjects: 16 patients were randomized into a treatment group or a control group, each constituting eight patients. Seven patients in the treatment group completed the schedule. After the control period, five of the patients in the control group also received treatment, making a total of 12 patients having completed the treatment sessions. Intervention: The intervention group went through a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week, each lasting for about 30 minutes, focusing on ego-strengthening, relaxation, releasing muscular tension and increasing self-efficacy. Main outcome measures: A questionnaire was developed in order to calibrate the symptoms before and after the 10 weeks period, and the results were interpolated into a scale from 0 to 100, increasing numbers representing increasing suffering.

Conditions
-----------------
Chronic Widespread Pain

Intervention / Treatment
-----------------
* Procedure: Hypnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic widespread pain for at least three months and at most five years. Exclusion Criteria: Patients having primarily other organic diseases or serious psychiatric disorders were excluded.

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

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

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 |
| --- | --- |
| No Intervention: A 1<br> | |
| Experimental: A 2<br>Treatment group | Procedure: Hypnosis<br>* a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week,<br>|

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
-----------------
Hypnosis,, Chronic widespread pain,, CWP,, General Practice
Culture Media for Borrelia Burgdorferi Sensu Lato

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to compare effectiveness of two different culture media for cultivation of Borrelia burgdorferi sensu lato from skin specimens obtained from patients with erythema migrans.

Official Title
-----------------
Comparison of Two Culture Media for Cultivation of Borrelia Burgdorferi Sensu Lato

Conditions
-----------------
Erythema Migrans

Intervention / Treatment
-----------------
* Other: MKP media
* Other: BSK-H media


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: erythema migrans in patients > 18 years Exclusion Criteria: pregnancy or lactation taking antibiotic with antiborrelial activity within 10 days erythema migrans localized on face or neck Each patient (235 subjects) provided two skin samples (470 skin samples).

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MKP media versus BSK-H media<br>one half of skin specimen obtained from erythema migrans patients was cultivated for Borrelia burgdorferi sensu lato in MKP media and the other half in BSK-H media | Other: MKP media<br>* one half of skin specimen was put in MKP media<br>Other: BSK-H media<br>* one half of skin specimen was put in BSK-H media<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative) | number of erythema migrans skin samples with Borrelia Burgdorferi sensu lato detected by Microscopy in Dark Field | weekly examination during 9 weeks of cultivating for individual specimen | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
erythema migrans, Lyme borreliosis, Borrelia burgdorferi, skin culture, culture media
Photographic Rhinometry Following Derm/Mohs Surgery for Skin Cancers

Study Overview
=================
Brief Summary
-----------------
Dermatological surgeons and patients routinely notice alterations in nasal shape and size following surgery and reconstruction. There is no uniform approach to objectively measure these changes. Anthropometric measurements are routinely used in rhinoplasty to assess outcomes, but they are time consuming and have not been reported as being used by dermatological surgeons. Soft-tissue measurements in profile photographs have been demonstrated to be useful for objective measurement of nasal change following surgery. This is a follow up study of the pilot study to assess the feasibility of photographic rhinometry as an objective tool, and (ii) to quantify changes following common dermatological surgical procedures on the nose. This follow-up study will aim to recruit a larger population sample to better quantify some of the changes occurring post-operatively.

Official Title
-----------------
Study of Use of 'Photographic Rhinometry' Following Derm and Mohs Micrographic Surgery for Skin Cancers: A Follow-up Study

Conditions
-----------------
Skin Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gender: Male and female participants Type of cancer: Undergoing surgery for removal of Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC)) Exclusion Criteria: Cases unable to consent to participation in the study Patients who are unable to complete the study assessments Patients below 18 years of age Patients undergoing surgery for other types of skin cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is to quantify changes following common dermatological surgical procedures on the nose. | Photographs will be taken with a camera in fixed zoom setting with a ruler placed in different anatomical sites before and after surgery. | baseline, pre-intervention/procedure/surgery and immediately after the intervention/procedure/surgery |
Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether an investigational medication will be more effective than an approved medication in reducing cholesterol levels.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Parallel Group, 28-Week Study to Evaluate the Efficacy and Safety of Ezetimibe and Simvastatin Co-administration Versus Atorvastatin in Patients With Hypercholesteremia

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: MK0653, ezetimibe / Duration of Treatment: 28 weeks
* Drug: Comparator: atorvastatin / Duration of Treatment: 28 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elevated cholesterol levels Exclusion Criteria: Liver disease Unstable medical conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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: MK0653, ezetimibe / Duration of Treatment: 28 weeks|nan|
|Drug: Comparator: atorvastatin / Duration of Treatment: 28 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect on the reduction in low density lipoprotein cholesterol (LDL-C) after the initial 6-week treatment period. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety/tolerability and evaluate effect on HDL-C & on reduction of LDL-C |  |  | 
| Evaluate % of pts who attain their NCEP-ATP III goal for LDL-C @ each dose level |  |  |
Clinical Evaluation of the Revised iLTS-D2

Study Overview
=================
Brief Summary
-----------------
A interventional, non-randomized, controlled study to evaluate the revised iLTS-D2 in anesthetized patients.

Detailed Description
-----------------
The revised Intubation laryngeal tube - disposable (iLTS-D) is a refined laryngeal tube, which allows a secondary intubation over the inserted laryngeal tube. The present study should reveal the effectiveness and practicability in anesthetized patients in the operation room.

Official Title
-----------------
Clinical Evaluation of the Revised iLTS-D2 in Effectivity and Practicability

Conditions
-----------------
Airway Management

Intervention / Treatment
-----------------
* Device: Effectiveness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective surgery patients under general Anesthesia Exclusion Criteria: Age <18 years Existing pregnancy Lack of consent inability to consent emergency patients

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Effectiveness<br>Evaluate the Effectiveness in insertion success, insertion times, influence of respiratory, cardiac and cerebral circulation | Device: Effectiveness<br>* Effectiveness and Practicability in anesthetized patient under controlled conditions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion time LT | Insertion of the laryngeal tube | in 30 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion time ET | Insertion of the endotracheal tube | in 60 seconds | 
| Rate of successful Intubation attempts | successful insertion and tracheal intubation | through study completion, an average of 120 seconds | 
| hemodynamics MAP | changes in MAP (mmHg) during cuff insufflation of laryngeal tube | through study completion, an average of 360 seconds | 
| hemodynamics Freq | changes in heart frequency (bpm) | through study completion, an average of 360 seconds | 
| hemodynamics rO2 | changes in cerebral oxygenation (percent) | through study completion, an average of 360 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Airway Morbidity
Mesenchymal Stem Cells; Donor and Role in Management and Reconstruction of Nonunion Fracture

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that mesenchymal stem cells can be isolated from fracture site, iliac crest, and tibial crest, and can be expanded to be used in the management of nonunion fracture.

Conditions
-----------------
Healing of Fracture

Intervention / Treatment
-----------------
* Drug: stem cells + hydroxy apatite
* Other: autograft taken from iliac crest


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: athropic nonunion fracture of the long bone Exclusion Criteria: immunocompromise, active infection, pathological fracture, ongoing hormonal therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stem cells<br>stem cells + hydroxy apatite | Drug: stem cells + hydroxy apatite<br>* patient will be transplanted with stem cells and hydroxyapatite<br>|
| Active Comparator: autograft<br> | Other: autograft taken from iliac crest<br>* patient will be transplanted with autograft<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healing of fracture | radiological union | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | visual analogue scale | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nonunion, stem cells, autograft, hydroxyapatite
DISH Data Analysis Study

Study Overview
=================
Brief Summary
-----------------
To perform extensive analyses of data from the Dietary Intervention Study of Hypertension (DISH)..

Detailed Description
-----------------
BACKGROUND: DISH was a multicenter, controlled, randomized study conducted in 1980-1983 of 496 patients, who were formerly participants in the Hypertension Detection and Follow-up Program and who had their blood pressure well controlled with medication. At DISH baseline they were randomized to continue medication or to be withdrawn from antihypertensive medication to determine if weight reduction or sodium restriction/potassium increase interventions could maintain these people under blood pressure control without drugs. Only the main findings regarding diastolic blood pressure control under the different diet regimens, were analyzed and reported during the course of DISH funding. Many questions which could be uniquely addressed by this comprehensive data base remained unexplored. DESIGN NARRATIVE: The investigators explored the questions dealing with demographic, clinical and physiologic predictors of relapse to the hypertensive state. They also analyzed the mortality experience of this cohort five years post DISH in relation to the DISH randomization groups and in relation to success in remaining off drugs during DISH. They did this by querying the National Death Index to determine who of the DISH participants died following the termination of DISH. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
A Long Term Safety Study With Atrasentan

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study is to evaluate long-term safety and tolerability of atrasentan 10 mg in men with hormone refractory prostate cancer.

Official Title
-----------------
A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan

Conditions
-----------------
Prostate Cancer, Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: Atrasentan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than or equal to 18 years, inclusive; Subject is currently active in an atrasentan clinical study OR has histologically or cytologically documented diagnosis of prostate adenocarcinoma and is considered hormone refractory; Karnofsky Performance Score greater than or equal to 60; Adequate hematologic function and liver function tests; No New York Heart Association (NYHA) class greater than or equal to 2.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atrasentan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Every 12 weeks | 
| Serious adverse events |  |  | 
| Oncology-related events (OREs) |  |  | 
| Deaths |  |  | 
| Study drug exposure |  |  | 
| Change from baseline in Karnofsky performance status |  |  | 
| Vital signs |  |  | 
| Stratification by treatment group from prior study |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and laboratory parameters |  | Every 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hormone Refractory Prostate Cancer, Adenocarcinoma of the Prostate