linjc16/ctgov huggingface dataset:
PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to verify efficacy and safety of a bilateral deep brain stimulation (DBS) of the Nucleus accumbens (NAc) as a treatment option for severe opioid addiction.

Official Title
-----------------
PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction

Conditions
-----------------
Opioid Addiction

Intervention / Treatment
-----------------
* Device: Deep brain stimulation：PINS Stimulation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old. In accordance with the diagnostic standards of DSM-IV & ICD-10 for addicted and DSM-IV for abstinence. Qualitative urine detection for opioids showing positive result. Cleared for 8 to 36 hours after their last drug taking. Fully understood and signed on informed consent. Exclusion Criteria: Person with consciousness disorder on opioid abstinence, seriously aggressive, heavily dehydrated and intending to commit suicide. Patients with serious liver and kidney dysfunction, pulmonary decompensation, or complicated with serious damage in other systems. Patients with serious infectious disease. Patients with history of serious neurological or psychiatrical diseases. Person with history of HIV infection or serious malnutrition. Dependent upon and addicted to multiple drugs. Attended some other drug trials within one month.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Deep Brain Stimulation<br>Stimulator is ON | Device: Deep brain stimulation：PINS Stimulation System<br> <br> * Other names: Non-rechargeable Implanted device;|
| Sham Comparator: Placebo<br>Stimulator is OFF | Device: Deep brain stimulation：PINS Stimulation System<br> <br> * Other names: Non-rechargeable Implanted device;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schedule for the Assessment of Negative Symptoms (SANS) |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Hunger Scale |  | 6 month | 
| Beck Depression Inventory |  | 6 month | 
| Buss & Perry Aggression Questionnaire |  | 6 month |
Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia (0653-026)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide an investigational drug to patients with a specific type of hypercholesterolemia (high cholesterol) or sitosterolemia (unusually high absorption of non-cholesterol sterols) in a treatment use setting.

Official Title
-----------------
An Open-Label, Worldwide, Treatment Use Study to Provide Ezetimibe 10 Mg/Day to Patients With Homozygous Familial Hypercholesterolemia or Homozygous Sitosterolemia

Conditions
-----------------
Hypercholesterolemia, Familial, Lipid Metabolism, Inborn Errors

Intervention / Treatment
-----------------
* Drug: Comparator: ezetimibe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Homozygous familial hypercholesterolemia or sitosterolemia Exclusion Criteria: Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study

Ages Eligible for Study
-----------------
Minimum Age: 8 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ezetimibe | Drug: Comparator: ezetimibe<br>* Ezetimibe (MK0653) 10 mg once daily for 3 years.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of clinical and laboratory adverse experiences in in patients with homozygous FH or homozygous sitosterolemia taking ezetimibe 10 mg/day |  | 3 years |
Circulating Cathodic Antigen Test Compared to Microscopy for Diagnosis of Urinary Schistosomiasis in Sohag

Study Overview
=================
Brief Summary
-----------------
Schistosomiasis is a chronic infection endemic in 74 tropical and sub-tropical countries. Sub-Saharan Africa carries the highest burden (90%) of schistosomiasis which caused by both Schistosoma mansoni and Schistosoma haematobium. The prevalence of Schistosomiasis should be assessed to control of the infection. This is usually achieved through surveys based on the use of traditional parasitological methods as urine filtration for S. haematobium. However, these traditional methods are time consuming, require an experienced technician and multiple samples due to light-infection and irregular shedding. Therefore, the point-of-care Circulating Cathodic Antigen (POC-CCA) urine test has been developed for the diagnosis of S. haematobium infection which is simple, rapid, sensitive and specific assay.

Official Title
-----------------
Circulating Cathodic Antigen Test Compared to Microscopy for Diagnosis of Urinary Schistosomiasis in Sohag

Conditions
-----------------
Urinary Schistosomiases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 100 outpatient children aged between 5 - 16 years Exclusion Criteria: Outpatient children should not have received schistosomiasis treatment (within the past 6 months) prior to the study

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 16 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 |
| --- | --- | --- |
| to evaluate the accuracy of rapid immunochromatographic assay (POC-CCA) compared with traditional microscopic examination for diagnosis of Schistosoma haematobium infection | comparing the sensitivity and specificity of rapid immunochromatographic assay with traditional microscopic examination for diagnosis of Schistosoma haematobium infection | 16 weeks following the startpoint of the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to estimate the prevalence of Schistosoma haematobium infection in outpatient children in Sohag | By examining the stool samples of 100 outpatient children and recording the number of cases with Schistosoma haematobium infection. | 16 weeks following the startpoint of the study. |
Diagnosis and Treatment Strategies in Patients With NSCLC With or Without EGFR Mutations.

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to compare the evolution of patients receiving first line treatment for locally advanced or metastatic lung cancer, taking into account if they were requested or not the EGFR mutation test as part of the diagnosis and treatment strategy. There is no assignment to any particular therapeutic strategy.

Detailed Description
-----------------
Study of cases and controls on diagnosis and treatment strategies in patients with NSCLC with or without EGFR mutations.

Official Title
-----------------
Study of Cases and Controls on Diagnosis and Treatment Strategies in Patients With NSCLC With or Without EGFR Mutations.

Conditions
-----------------
Stage IIIB/IV, Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with confirmed diagnosis of lung adenocarcinoma, stage IIIb/IV. Patients under 1st line treatment against lung adenocarcinoma. Exclusion Criteria: Patients not having the information required by the protocol.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br> | |
| Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 12 months after the diagnosis of advanced disease | 
| Overall Survival |  | 12 months after the diagnosis of advanced disease | 
| Number of hospitalizations |  | 12 months after the diagnosis of advanced disease | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-Small Cell Lung Cancer,, Epidermal Growth Factor Receptor mutation,, Lung cancer,, Lung adenocarcinoma
A Study of Telemedicine Shared Medical Appointments (SMAs) Versus Individual Telemedicine Visits for People With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if a telemedicine group doctor's appointment is a practical (feasible) and acceptable method for following people with prostate cancer being managed with active surveillance when compared with the usual approach of individual telemedicine visits, which involve the participant visiting a doctor on their own. The researchers will compare the telemedicine group and individual visits by measuring on participant satisfaction and quality of life in each type of visit. Telemedicine is the use of secure video technology on a desktop computer, laptop, smartphone, or tablet to provide and receive healthcare from a distance.

Official Title
-----------------
Feasibility Study of Randomizing Patients to Telemedicine Shared Medical Appointments Versus Telemedicine Single Visits for Men With Prostate Cancer on Active Surveillance

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A scheduled appointment for a subsequent Active Surveillance (AS) follow-up visit for management of localized prostate cancer Biopsy Gleason score 3+3=6 (Grade Group 1) or biopsy Gleason score 3+4=7 (Grade Group 2) Clinical T stage ≤T2B Access to a device with Zoom Ability to speak and understand English Exclusion Criteria: Plan to undergo a prostate biopsy at this follow-up visit

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Shared Medical Appointments<br> | |
| Usual Care Appointments<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accrual number |  | 1 year | 
| patient satisfaction | using MSK Engage portal survey | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence to active surveillance | the number who drop out of AS in the absence of disease progression | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telemedicine, Shared Medical Appointments, Individual Telemedicine Visits, 22-184
Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery

Study Overview
=================
Brief Summary
-----------------
The effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to Floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac and aortic thoracic surgery.

Official Title
-----------------
Prospective, Randomised, Controlled Investigation Comparing the Safety and Performance of 032-11 Surgical Haemostat With FLOSEAL® Haemostatic Matrix in Cardiac Surgery and Thoracic Aortic Surgery.

Conditions
-----------------
C.Surgical Procedure; Cardiac, Haemorrhage.

Intervention / Treatment
-----------------
* Device: 032-11
* Device: Floseal (R)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must be equal or greater than 18 years old The patient must have elective or non-elective urgent cardiac surgery or thoracic aortic surgery The patient must have no childbearing potential or have a negative serum or urine pregnancy test within 7 days of the planned surgery or in the opinion of the Investigator performs adequate contraception The patient is willing and able to be contacted for the follow-up visit at 6- 8 weeks The patient must provide written informed consent using a form that is reviewed and approved by the IEC Exclusion Criteria: The patient is currently enrolled in this or another investigational device or drug trial that has not completed the required follow up period. The patient has a known hypersensitivity to materials of bovine origin The patient does not wish to receive materials of bovine or shellfish origin for any reason

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 032-11<br>032-11 topical haemostat. | Device: 032-11<br>* Topical haemostat<br>|
| Active Comparator: Floseal (R)<br>Floseal(R) topical haemostat | Device: Floseal (R)<br>* Topical haemostat<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemostasis success | Proportion of patients achieving haemostasis success following the first application of compression. | Intra-operative |
Sinus Lift Using PTFE Titanium Reinforced Membrane

Study Overview
=================
Brief Summary
-----------------
Various attempts have been implemented using different materials and techniques to augment the maxillary sinus floor enhancing autogenous bone formation to allow proper dental implant positioning. The aim of this study is to evaluate the sinus lift procedure using polytetrafluoroethylene (PTFE) titanium-reinforced membrane to maintain the space formed after Schneiderian membrane elevation followed by immediate implant placement.

Official Title
-----------------
Evaluation of Direct Sinus Lift Using Ptfe Titanium Reinfored Membrane Assosiated With Immediate Implant Placement (Clinical Trial)

Conditions
-----------------
Sinus Lift

Intervention / Treatment
-----------------
* Procedure: Direct sinus lift with titanium reinforced PTFE membrane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both genders requiring implant placement in posterior maxilla Age range: 40-60 years. Good oral hygiene Healthy maxillary sinus free from pathology The minimum crestal bone height is (4-6) mm Patients who are willing and fully capable to comply with the study protocol. Exclusion Criteria: Sinus infection Tumors or pathologic lesions in sinus Severe allergic rhinitis. Chronic topical steroid use. Radiation therapy. Psychologic / mental impairment Acute infection (periodontitis or mucosal infection Patients on radiotherapy or chemotherapy. Alcohol or drug abuse. Patient with systemic disorder (uncontrolled Diabetes mellitus, autoimmune diseases, bone diseases, etc.) Smokers Parafuctional habits

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 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: Direct Sinus elevation using SLA Kit<br> | Procedure: Direct sinus lift with titanium reinforced PTFE membrane<br>* Implants will be placed immediately after sinus lifting procedure and maintaining the sinus membrane in position using PTFE titanium reinforced membrane.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in implant stability | It will be measured using Osstell | at baseline and 6 months | 
| Change in bone formation | It will be measured uisng CBCT on Demand 3d software | at baseline and 6 months | 
| Change in bone height | It will be measured uisng CBCT on Demand 3d software | at baseline and 6 months | 
| Change in bone density | It will be measured uisng CBCT on Demand 3d software | at baseline and 6 months |
Efficacy of Symbicort pMDI Administered Once Daily in Adolescents and Adults During 12 Weeks - STEM

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare a dose of Symbicort taken once daily with other dosage regimens of Symbicort , budesonide and placebo for the treatment of asthma in adolescents and adults

Official Title
-----------------
A 12 Week, Randomized, Double-Blind, Double-Dummy, Placebo and Active-controlled Study of Symbicort pMDI Administered Once Daily in Adults and Adolescents With Asthma - STEM

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: budesonide/formoterol
* Drug: budesonide and placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of asthma and baseline lung function tests as determined by the protocol Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol Exclusion Criteria: Severe asthma Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers

Ages Eligible for Study
-----------------
Minimum Age: 16 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: budesonide/formoterol<br> <br> * Other names: Symbicort;|
| Placebo Comparator: 2<br> | Drug: budesonide and placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in evening PEF |  | Daily throughout the 12 week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes |  | Daily throughout the 12 week treatment period | 
| Health-related quality of life |  | 4 assessments within 12 week treatment period | 
| Routine safety assessments |  | 4 assessments within 12 week treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, adolescents, adults, Symbicort, budesonide/formoterol, budesonide
aHUS Observational Long Term Follow-Up

Study Overview
=================
Brief Summary
-----------------
There is growing but limited information on the long term clinical status of aHUS patients who have previously received or are continuing to receive treatment with eculizumab. This study is designed to collect clinical data that will provide insight into the long-term outcomes of patients with aHUS.

Official Title
-----------------
An Observational, Multi-Center, Multi-National, Long Term Follow-Up Study of Atypical Hemolytic Uremic Syndrome (aHUS) Patients Treated With Eculizumab in a Prior Clinical Study

Conditions
-----------------
Atypical Hemolytic Uremic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aHUS patients who participated in any one of the aHUS-eculizumab clinical studies. aHUS patients or legal representative who are able and willing to given written informed consent for their study information to be collected and retained in a database. Exclusion Criteria: Not applicable.
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 |
| --- | --- | --- |
| TMA complication-free survival | Assess the long term efficacy of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study. | 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response, change over time of value for platelets, LDH, eGFR, Hgb, TMA intervention | Assess the long term safety of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study by collecting data on serious adverse events and targeted adverse events. | 5 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atypical Hemolytic Uremic Syndrome, aHUS, Eculizumab