linjc16/ctgov huggingface dataset:
A Phased-Implementation Feasibility and Proof-of-Concept Study to Assess Incorporating the NIDA CTN Common Data Elements (CDEs) Into the Electronic Health Record (EHR) in Large Primary Care Settings (CDE-EHR-PC Study), Phase 2

Study Overview
=================
Brief Summary
-----------------
This is a 4-phase study to implement the NIDA (Common Data Elements) Common Data Elements (CDEs) in primary care settings. The study will be conducted at three adult primary care clinics, in two large health systems. Each phase will include deliverables essential to move to the next phase, and an independent Advisory Committee will review progress and make recommendations at each transition about how best to progress to each subsequent phase. Based on progress during earlier phases, the Advisory Committee may recommend expansion to additional clinics or health systems during the second part of Phase 4. Phase 2 prepares for implementation of the screening and CDS tools as part of routine clinical practice. A key component of this phase is tailoring the screening and CDS tools through an iterative process of usability testing and adaptation of their design. In the KTA framework, this phase corresponds to the 'select, tailor, and implement interventions' step. Simultaneously, investigators will plan for implementation in one clinic of the MSHS system by identifying clinical champions, educating clinic leadership and staff, and conducting a workflow analysis to identify barriers and facilitators of implementation.

Official Title
-----------------
A Phased-Implementation Feasibility and Proof-of-Concept Study to Assess Incorporating the NIDA CTN Common Data Elements (CDEs) Into the Electronic Health Record (EHR) in Large Primary Care Settings (CDE-EHR-PC Study), Phase 2

Conditions
-----------------
Substance Abuse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking adult individuals aged 18 years or older, and employee at a Wave 1 clinic. Clinical implementation leaders Clinical implementation leaders are practicing PCPs who provide feedback to the research team and support their colleagues on implementing screening, using the CDS, and carrying out clinical interventions and referrals to address unhealthy substance use. One or two primary care providers will be identified from each clinic site to advise the research team on implementation and to serve as a resource for their colleagues. Exclusion Criteria: Inability to provide informed consent.

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 |
| --- | --- | --- |
| Drug Abuse Screening Test (DAST-10) | 10-item brief screening tool that can be administered by a clinician or self-administered. Each question requires a yes or no response, and the tool can be completed in less than 8 minutes. | 12 Months |
Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating the combination drug will be determined.

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: OPC-1085EL ophthalmic solution
* Drug: Carteolol long-acting ophthalmic solution
* Drug: Latanoprost ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are considered medically healthy per investigator's judgment Exclusion Criteria: Subjects with ocular conditions as defined by the protocol Subjects with intraocular pressure: <10 or ≥22 mmHg

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPC-1085EL ophthalmic solution<br>Once daily | Drug: OPC-1085EL ophthalmic solution<br> <br> |
| Active Comparator: Carteolol long-acting ophthalmic solution<br>Once daily | Drug: Carteolol long-acting ophthalmic solution<br> <br> |
| Active Comparator: Latanoprost ophthalmic solution<br>Once daily | Drug: Latanoprost ophthalmic solution<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Carteolol |  | Day 1 and Day 7 | 
| Cmax of Latanoprost Acid |  | Day 1 and Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax of Carteolol |  | Day 1 and Day 7 | 
| Tmax of Latanoprost Acid |  | Day 1 and Day 7 |
Study to Evaluate Nosocomial Transmission of Influenza

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether influenza can be reliably transmitted from children to susceptible contacts in a health care setting. The goal is to develop a transmission that can then be used to assess interventions to prevent transmission Research objectives: To develop a model to investigate the frequency of influenza transmission from an infected child to a susceptible health care worker Research Hypotheses: Influenza viruses can be transmitted from infected children to exposed health care workers

Detailed Description
-----------------
CHildren with influenza infection presenting to ED will be identified by RAT. Healthy healthcare worker subjects will expose themselves and perform specific activities with the child. subjects will be followed by diary card, clinical symptom scores and virology swabs to assess frequency of transmission

Official Title
-----------------
Pilot Study to Develop a Model to Evaluate Nosocomial Transmission of Influenza

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Infected Children Age < 16 years Parents or legal guardians willing to give informed written consent Presenting with a febrile illness confirmed as influenza by near patient rapid antigen testing Healthy volunteers Willing to give informed written consent Exclusion criteria Children No parents or legal guardians able to give informed consent Healthy volunteers known allergy to oseltamivir or zanamivir presence of underlying condition or concomitant therapy requiring dose alteration of oseltamivir (severe renal or hepatic failure; methotrexate and probenecid) underlying immunosuppressive disorder known galactose intolerance underlying chronic medical condition known to increase risk of influenza-related complications (including asthma, chronic pulmonary airways disease, chronic cardiovascular disease, diabetes mellitus, chronic neurological disorder) inability or contraindication to collection of nasal swabs previous influenza vaccination within 2 years current smoker pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heathcare worker<br>health care worker exposed to patient with influenza | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of transmission of influenza |  | 1 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza, transmission
A Clinical Evaluation of Omron Digital Blood Pressure Monitor

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the blood pressure level of the patients, using a cuff ranged 17 - 50 cm.

Official Title
-----------------
A Clinical Evaluation of OMRON Digital Blood Pressure Monitor, HEM-9210T, Blood Pressure Measurement Accuracy Based on Auscultation

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Device: OMRON blood pressure monitor HEM-9210T


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Upper arm circumference: 17-50cm Exclusion Criteria: Patients who has arrhythmia. When body motion is observed during measurement. Korotkoff sound is poor quality. Patient's arm circumference is outside cuff range. Patient's auscultatory systolic blood pressure readings differ by more than 12mmHg. and patient's diastolic blood pressure readings differ by more than 8mmHg. Patients stated they did not wish to continue with the study and it is stopped before completion.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: OMRON blood pressure monitor HEM-9210T|To measure systolic blood pressure, diastolic blood pressure and pulse rate in patients.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verify the accuracy of measure functions of device | The aims of this study was to assess the accuracy of the Omron blood pressure monitor according to the ANSI/AAMI/ISO81060-2:2013. And it is analyzed and evaluated at least 85 patients based on the AAMI/ANSI/ISO81060-2:2013. | 30 days |
Interest of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Auditory Hallucinations

Study Overview
=================
Brief Summary
-----------------
Auditory hallucinations are common (present in 60-70% of cases) and extremely debilitating. Behavioral disorders associated with them can have serious social repercussions. However, in 25% of cases the usual antipsychotic drug treatments are incompletely or totally ineffective. Fifteen subjects will be included after collection and signed their informed consent. The rTMS treatment is made of 4 sessions of 13 minutes spread over two days, at a frequency of 20 Hz and an intensity of 80% of motor threshold at rest. These constants are used to stay below the risk of occurrence of seizures, the only serious side effects identified. Furthermore the rTMS treatment is almost painless: tension headaches are the main side effects and make amends with simple analgesics. rTMS is devoid of neurocognitive effects. The LEFT stimulation site will be established through a anatomofunctional imaging before treatment (between D-7 and D0). Treatment efficacy will be evaluated daily during treatment (days 1 and 2) and during the first 2 weeks of starting treatment.

Conditions
-----------------
Schizophrenic Disorders

Intervention / Treatment
-----------------
* Device: Transcranial magnetic stimulation: rTMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with schizophrenic disorders aged from 18 to 60 years old Patients suffering from auditory hallucinations undergoing antipsychotic treatments Written signed consent Exclusion Criteria: Pregnancy or breastfeeding Counter-indication to MRI or to rTMS

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Transcranial magnetic stimulation: rTMS<br>rTMS : 4 sessions of 13 minutes, with 2 sessions a day, at 20Hz frequency and at an intensity of 80% of rest motor threshold will be delivered | Device: Transcranial magnetic stimulation: rTMS<br>* 4 sessions of 13 minutes, with 2 sessions a day, at 20Hz frequency and at an intensity of 80% of rest motor threshold will be delivered<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOFFMAN score |  | change between baseline and day 3 or day 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, auditory hallucinations, TMS
Posterior Cruciate Ligament Reconstruction Using Knot/Press-fit Technique

Study Overview
=================
Brief Summary
-----------------
This study presents an arthroscopic-assisted PCL reconstruction using femoral knot/press-fit technique with a periosteum-enveloping graft in tibial tunnel. The investigators evaluated the results of patients with PCL ruptures, who undergoing PCL reconstruction using this unique technique.

Official Title
-----------------
Non-hardware Posterior Cruciate Ligament Reconstruction Using Knot/Press-fit Technique With Periosteum-Evenloping Hamstrings Tendon Autograft

Conditions
-----------------
PCL TEAR

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCL TEAR Exclusion Criteria: PL INSTBILITY

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 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 |
| --- | --- | --- |
Multiple Myeloma Minimal Residual Disease

Study Overview
=================
Brief Summary
-----------------
Three methods including flow cytometry, next generation sequencing and determination of circulating tumor cells will be performed at different time points in patients with previously undiagnosed multiple myeloma in order to determine the most sensitive method to detect residual disease

Official Title
-----------------
Comparison of Three Methods to Evaluate Residual Disease in Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Biological: blood samples and bone marrow aspirates will be collected


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years previously undiagnosed myeloma eligible for high dose therapy and bone marrow transplantation signed consent Exclusion Criteria: ongoing therapy for another neoplasia Patients with other hematologic malignancies, patients deprived of liberty for administrative or judicial reasons previously treated for myeloma

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 |
| --- | --- |
| patients with multiple myeloma<br>blood samples and bone marrow aspirates will be collected in patients at different time point | Biological: blood samples and bone marrow aspirates will be collected<br>* Serial analysis will be performed at different time point in order to evaluate the presence or absence of residual disease after different treatment steps (before treatment, after induction, after intensification, after consolidation)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of residual disease | study the sensitivity of the method of quantification of circulating tumor cells compared to 2 others methods of detection | Residual disease is assessed up to 18 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kinetic of variation of the residual tumor cells detected by flow cytometry method | % positive cells in bone marrow sample | 18 months | 
| kinetic of variation of the residual tumor cells detected by new generation sequencing method | % positive in bone marrow sample | 18 months | 
| kinetic of variation of the circulating tumor cells | number of cells / mL of blood | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
residual disease
Outcome of Varicocelectomy on Normal Semen in Patients Complaining of Orchialgia

Study Overview
=================
Brief Summary
-----------------
varicoclelectomy is done for subfertiltiy and varicocele induced orchialgia. The effect of varicocelectomy on semen analysis is controversial. Many articles report favorable outcomes and others do not. Most study don't focus on varicocelectomy done for varicocele induced orchialgia,and those studies dont report on postoperative semen. This study will focus on the effect of operation on the semen postoperatively .

Official Title
-----------------
Outcome of Subinguinal Varicocelectomy on Normal Semen in Patients Complaining of Orchialgia

Conditions
-----------------
Varicocele, Pain, Fertility Issues

Intervention / Treatment
-----------------
* Procedure: varicocelectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary varicocele Patient's age more than 19 years Normal semen analysis (according to the WHO 5th guide to semen parameters where sperm concentration equal 15 million per ml , total sperm number 40 million per ejaculate ,normal morphology 4 % and motility A =25% or a+b = 32% is considered normal. Scrotal pain after exclusion of other causes. Exclusion Criteria: 1- Recurrent varicocele

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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

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: pre-operative and postoperative<br>the patients who will undergo the operation to treat the pain | Procedure: varicocelectomy<br>* operation for varix ligation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sperm motility | semen analysis will be done preoperative and post-operative | 3 months postoperative is our aim | 
| sperm morphology | semen analysis will be done preoperative and postoperative | 3 months postoperative is our aim | 
| sperm number | semen analysis will be done preoperative and postoperative | 3 months postoperative is our aim | 
| pain of scrotum | subjective sensation measured by visual analogue score preoperative and postoperative | 3 months postoperative is our aim |
CD49 in Optimization The Cologenicity of Mesenchymal Stem Cell Culture Passage

Study Overview
=================
Brief Summary
-----------------
Human mesenchymal stem cells (MSCs) due to their regenerative and immunomodulatory properties are widely used for the treatment of bone and cartilage damage, cardiovascular, gastrointestinal, autoimmune, neurodegenerative diseases and cancer .It is shown that the use of MSCs in therapy is safe and can be effective .In 2006, the International Society for Cellular Therapy (ISCT) proposed the minimal criteria to define human MSCs. First, MSCs must be plastic-adherent when maintained in the standard culture conditions. Second MSCs must express CD105, CD73 and CD90, and lack expression of CD45, CD34, CD14 or CD11b, CD79a or CD19 and HLA-DR surface molecules.

Official Title
-----------------
CD49 in Optimization The Cologenicity of Mesenchymal Stem Cell Culture Passage

Conditions
-----------------
Umbilical Cord of Normal Labor

Intervention / Treatment
-----------------
* Device: flow cytomery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal babies delivered by normal labor Exclusion Criteria: diseased or congenital anomalies

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: flow cytomery|take sample of Wharton jelly and culturing it to know the best time for mesenchymal stem cell growth|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation the best passage of MSC culture by CD49 surface marker | evaluation the best passage of MSC culture by CD49 surface marker | 7 months |
Multicenter Subcutaneous ICD Registry

Study Overview
=================
Brief Summary
-----------------
This multicenter registry aims to collect data regarding S-ICD longevity, and battery and lead failure rates. Only clinically collected data is gathered in this registry.

Official Title
-----------------
Multicenter Registry of Subcutaneous ICD Patients

Conditions
-----------------
ICD, ICD Malfunction

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: S/P S-ICD Implantation Exclusion Criteria: n/a
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generator Explantation | Incidence of S-ICD generator explantation, due to battery depletion, infection or system upgrade. Assessed by medical records and device interrogation. | from baseline to incidence of explantation through study completion, an average of 5 year | 
| Lead Failure | Incidence of S-ICD lead failure. Assessed by medical records and device interrogation. | from baseline to incidence of lead failure,through study completion, an average of 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Battery Longevity | Incidence of regular battery depletion. Assessed by medical records and device interrogation. | from baseline to incidence of battery depletion through study completion, an average of 5 year |