linjc16/ctgov huggingface dataset:
Mental Health Symptom Monitoring Utilizing the Cogito Behavioral Analytic Platform

Study Overview
=================
Brief Summary
-----------------
The primary objective of this project is to test the acceptability and feasibility of a mobile application to facilitate mental health symptom monitoring and follow-up among Veterans. During the course of the study, the research application will be installed on participants' mobile phone. The application on the participants' phone will be recording data about their behavior. Participants will also be asked to complete bi-weekly surveys via the app.

Official Title
-----------------
Mental Health Symptom Monitoring Utilizing the Cogito Behavioral Analytic Platform

Conditions
-----------------
Mobile Applications, Cell Phone Use, Mental Health Issue, Acceptability of Health Care, Feasibility

Intervention / Treatment
-----------------
* Behavioral: Cogito Companion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Veterans between the ages 18-89 years of age at the time of enrollment able to provide signed and dated informed consent has anandroid platform phone and is willing to use phone and personal data plan to participate Exclusion Criteria: Participation in conflicting Rocky Mountain MIRECC interventional protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants allocated to Cogito Companion<br>Participants will have access the Cogito Companion for a three-month period post-consent. Passive data collection will also occur during this period. As a secure, privacy-compliant mobile app, the Cogito Companion facilitates the non-invasive collection, transfer, integration, analysis, and reporting of objective behavioral indicators. | Behavioral: Cogito Companion<br>* During the course of the study, the research application (Cogito Companion) will be installed on participants' mobile phone. The application on the participants' phone will be recording data about their behavior. Participants will also be asked to complete bi-weekly surveys via the app.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Client Satisfaction Questionnaire -8 | Veterans' satisfaction with app | 3 months | 
| Narrative Evaluation of Intervention Interview (NEII). | Ease of Implementation per Veterans | 3 months |
G-PLUS (GALLANT, GALLEX and ARMOR - Post Treatment Follow-up Study)

Study Overview
=================
Brief Summary
-----------------
This is a long-term safety follow-up study to assess the post-treatment safety, at 12 and 24 months, in patients with type 2 diabetes after participation in the phaseII/III studies GALLANT, GALLEX and ARMOR. In addition, selected patients, including those with pre-defined laboratory or clinical findings, will have a 12-week post-treatment follow-up visit, including laboratory evaluation and adverse event recording.

Official Title
-----------------
A Long-Term, Post-Treatment, Safety Follow-Up, Multi-Center Study in Patients With Type 2 Diabetes Mellitus From the GALLANT, GALLEX or ARMOR Studies.

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of a written informed consent Men or women who either completed at least 6 months in a previous treatment study GALLANT, GALLEX or ARMOR or met a pre-defined laboratory or clinical finding during participation in any of the said studies. Exclusion Criteria: Received open-label treatment with tesaglitazar (since this is a post-treatment 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Evaluation of Genetron IDH1 PCR Kit in Glioma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this trail is to evaluate the performance of Genetron IDH1 PCR Kit in Glioma patients using real-time PCR method.

Detailed Description
-----------------
This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron IDH1 PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. Combined with the results of clinicopathological classification, the incidence of IDH1 gene R132H mutation in different subtypes was counted to evaluate the clinical performance of the Genetron IDH1 PCR Kit.

Official Title
-----------------
Clinical Evaluation of Genetron IDH1 PCR Kit in Glioma Patients

Conditions
-----------------
Glioma, Malignant, Glioma, Mixed

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enroll cases in strict accordance with the requirements of the study The remaining samples after routine clinical testing The collection and processing of samples meet the requirements of standard laboratory operations and product instructions The relevant information of the sample is complete, including sample number, gender, age, and possible clinical diagnosis information Each sample must have HE staining results (hematoxylin-eosin staining) Pathological examination diagnosed as glioma, other brain tumors or normal tissues Number of samples: 10 pieces of each sample with a thickness of 10μm, and the tumor content is not less than 50% Exclusion Criteria: Incomplete sample information Severely contaminated samples Samples that do not meet the requirements of sample collection and processing
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 |
| --- | --- | --- |
| Efficacy of the Genetron IDH1 PCR Kit | The main purpose of this study is: by evaluating the Genetron IDH1 PCR Kit to compare the results of the Sanger sequencing method, and to calculate the coincidence rate and consistency of the two methods. | 3 months |
Efficacy, Safety and Tolerability of Neramexane in Comparison to Placebo in Patients With Subjective Tinnitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus

Conditions
-----------------
Subjective Tinnitus

Intervention / Treatment
-----------------
* Drug: Neramexane mesylate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 18 to 75 years with a clinical diagnosis of first onset, persistent (i.e. tinnitus sghould never be absent for >24 hours in a row), subjective, uni-or bilateral tinntius present for at least 3 months but not more than 12 months. Exclusion Criteria: Clinical diagnosis of intermittent or pulsatile tinnitus Patients who have tinnitus as a concomitant symptom of an otological/neurological disease(such as otitis media, Meniére´s disease, otosclerosis, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Drug: Neramexa mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day | Drug: Neramexane mesylate<br>* Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day, 12 weeks follow-up.<br>|
| Placebo Comparator: 2<br>Drug: Placebo Double-blind treatment period of 17 weeks placebo | Drug: Placebo<br>* Double-blind treatment period of 17 weeks placebo, 12 weeks follow-up.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 Tinnitus Handycap Inventory-12) total score change from baseline to end of treatment |  | Screening, Baseline, week 5, 13, 17 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TBF-12 factorial scores, individual respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics |  | 29 weeks | 
| safety parameters |  | 29 weeks |
One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and effectiveness of the enVista® One-Piece Hydrophobic Acrylic intraocular lens (IOL), following primary implantation for the visual correction of aphakia in adults 18 years of age or older in whom the cataractous lens has been removed by an extracapsular cataract extraction method (eg, small incision phacoemulsification).

Official Title
-----------------
A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of a Bausch + Lomb One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction

Conditions
-----------------
Aphakia, Cataract

Intervention / Treatment
-----------------
* Device: enVista


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction. Subjects must have a best corrected visual acuity (BCVA) equal to or worse than 20/40 in the study eye, with or without a glare source. Subjects must have a BCVA projected to be better than 20/30 after IOL implantation in the study eye. Exclusion Criteria: Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated. Subjects with any other serious ocular pathology, or underlying serious medical conditions, which based on the Investigator's medical judgment, could confound the results of the 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: enVista<br>enVista One-Piece Hydrophobic Acrylic Intraocular Lens | Device: enVista<br>* One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation. | 120-180 days (visit 4) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ocular surgery, phacoemulsification
Blood Flow Index as an Indicator of Successful Peripheral Nerve Block

Study Overview
=================
Brief Summary
-----------------
Laser speckle contrast imaging (LSCI) allows real-time, non-invasive, quantitative measurements of regional blood flow. The aim of this prospective observational study was to evaluate the blood flow changes by LSCI after peripheral nerve block and determine whether this novel optical technique can be used as a reliable indicator of successful blocks.

Detailed Description
-----------------
Methods: One hundred adult patients scheduled for elective upper or lower limb surgery with peripheral nerve block will receive LSCI measurements and pinprick sensory tests before the block and at 5-min intervals till 30 min after the block. The sensitivity, specificity of LSCI as a diagnostic method will be determined by receiver operator characteristic analysis. Clinical Implications: LSCI with quantitative data could be used as an indicator of successful blocks.

Official Title
-----------------
Blood Flow Index as an Indicator of Successful Peripheral Nerve Block : A Prospective Observational Study Using Laser Speckle Contrast Imaging.

Conditions
-----------------
Laser

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent American Society of Anesthesiologists physical statusⅠ-Ⅱ Undergo elective upper or lower limb surgery with peripheral nerve block Exclusion Criteria: refusal to participate in the study peripheral vascular disease digit injury or deficiency colored or infected fingernails/toenails BMI>35 those who had taken vasodilatory drugs before surgery preoperative analgesic medications Any contraindications to peripheral nerve block such as coagulation abnormalities, allergy to local anaesthetics, peripheral neuropathy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Peripheral nerve block group<br>patients scheduled for elective upper or lower limb surgery with peripheral nerve block will receive LSCI measurements and pinprick sensory tests at 5 min before the block and at 5-min intervals till 30 min after the block. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic power of LSCI and pinprick sensory tests for predicting successful and failed blocks | sensitivity and specificity | at 5-min intervals till 30 min after regional block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood flow index | perfusion unit(PU) | 5 min before regional block and at 5-min intervals till 30 min after regional block | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral nerve block, laser speckle contrast imaging, blood flow index
Long-Term Safety of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate the long-term safety and tolerability of renzapride at a dose of 4 mg taken once daily for 12 months in women with constipation-predominant irritable bowel syndrome (IBS-C).

Detailed Description
-----------------
Since IBS is a chronic condition affecting patients over many years, it is anticipated that renzapride will be prescribed and used by patients on a daily basis for long periods of time. Hence the need to understand its long-term safety and tolerability in the target population. This study is open label and so all subjects will take renzapride and will know that they are taking it. Enrolment in to this study is restricted to subjects completing a 12-week, placebo-controlled study of the effectiveness of renzapride in providing relief from IBS-C (Study no. ATL1251/038/CL).

Official Title
-----------------
A Phase III, Multicenter, Open Label, Extension Study to Evaluate the Long-Term Safety of Renzapride 4 mg Once Daily in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

Conditions
-----------------
Constipation-Predominant Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: Renzapride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: completed 12 weeks treatment in the preceding pivotal study ATL1251/038/CL Exclusion Criteria: Subjects who are pregnant or breastfeeding

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>All subjects take two capsules (2x renzapride 2 mg) daily, from the day of enrolment until the scheduled visit at the end of Week 52 | Drug: Renzapride<br>* All subjects take two capsules (2x renzapride 2 mg) daily, from the day of enrolment until the scheduled visit at the end of Week 52<br>* Other names: BRL 24924;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs, routine clinical laboratory data, 12-lead ECG |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Constipation predominant irritable bowel syndrome
A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine in Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the efficacy of GSK Biologicals' influenza vaccine (Fluarix™) administered intramuscularly in adults.

Official Title
-----------------
A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine (Fluarix™) Administered Intramuscularly in Adults

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Fluarix vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female age between 18 and 64 years at the time of the first vaccination. non-childbearing female Exclusion Criteria: Use of non-registered products Pregnancy Hypersensitivity to a previous dose of influenza vaccine Acute disease at the time of enrolment/vaccination. History of allergy or reactions likely to be exacerbated by any component of the vaccine Administration of any other influenza vaccine for the season 2006-2007 Chronic disorders of the pulmonary or cardiovascular system, including asthma. Administration of immune-modifying drugs Administration of immunoglobulins and/or any blood products History of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, asthma or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus)

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Fluarix vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of confirmed influenza |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of influenza like illness |  |  | 
| Occurrence of pneumonia |  |  | 
| Immune response at days 0 and 21 |  |  | 
| Safety during 7 Months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza vaccine, Prophylaxis Influenza vaccine
Case Notes Review on Patients With Hereditary Haemorrhagic Telangiectasia

Study Overview
=================
Brief Summary
-----------------
This observational study is for individuals with Hereditary haemorrhagic telangiectasia and pulmonary arteriovenous malformations that are reviewed at the Hammersmith Hospital, London.

Detailed Description
-----------------
The Hammersmith Hospital provides a clinical service for patients with Hereditary haemorrhagic telangiectasia and pulmonary arteriovenous malformations that is unique in the United Kingdom. Measurements obtained as part of standard clinical practice that has evolved since 1985 allow us to assess whether particular groups of individuals that we see are more prone to recognised complications such as strokes, brain abscesses, pregnancy related complications or pulmonary hypertension. We hypothesise that certain clinical characteristics will predict the susceptibility of individuals to particular complications.

Official Title
-----------------
Hammersmith Hospital Patients With Pulmonary Arteriovenous Malformations (PAVMs) and Hereditary Haemorrhagic Telangiectasia

Conditions
-----------------
Telangiectasia, Hereditary Hemorrhagic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients attending Hammersmith Hospital Exclusion Criteria: None
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 |
| --- | --- | --- |
| Stroke | Ischaemic stroke attributable to PAVMs | Prospective | 
| Venous thromboemboli (VTE) | VTE of any origin | Prospective | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary arteriovenous malformations