linjc16/ctgov huggingface dataset:
Osteopathic Manipulative Medicine and Kinetics

Study Overview
=================
Brief Summary
-----------------
Back pain affects the majority of the population at some time. Currently there are no published and scientifically accepted objective measures to support manual medicine diagnostic and treatment techniques for back pain. The purpose of this project is to collect and evaluate objective (pressure and motion) data from standard clinical diagnostic tests.

Conditions
-----------------
Cervical Spine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HEalthy and no pain in cervical spine Pain of 3 or greater in cervical spine Exclusion Criteria: pain of less than 3 in the cervical spine region pregnant

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pain free<br>No pain in the cervical spine | |
| Pain<br>Pain of 3 or greater on a VAS scale for the cervical spine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of obtaining force data during clinical assessment | Assessment of force sensing equipment while conducting clinical diagnoses | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteopathic Medicine, Cervical Spine, Kinetics
Normal and Abnormal ERP During ToM and Emotional Conflicts in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Case-control comparison of clinical population, interventional and single-center research.

Detailed Description
-----------------
The main objective of this study is to define and characterize electrophysiological markers of the existing social cognition disorders in schizophrenia. Two groups of subjects are recorded : schizophrenic patients and healthy controls. Visual reinforcement effect during theory of mind judgment is tested.

Official Title
-----------------
Normal and Abnormal Event Related Potentials During Attribution of Intentions to Others and Resolution of Emotional Conflicts in Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: Theory of mind without visual cues
* Behavioral: Theory of mind without visual cues


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent French mother tongue Schizophrenia diagnosis according to DSM-IV-R for the patient group Exclusion Criteria: Coma history, epilepsy, head trauma with loss knowledge greater 10 min ECT older than 1 month DSM-4 R criteria of toxic addiction in the last 6 months Deafness or blindness Scalp pathology Intracranial implanted device

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Treated or hospitalized patients for schizophrenia. | Behavioral: Theory of mind without visual cues<br>* Theory of mind stimulation without visual reinforcement while performing EEG recordings<br>Behavioral: Theory of mind without visual cues<br>* Theory of mind stimulation with visual reinforcement while performing EEG recordings<br>|
| Experimental: Control<br>No schizophrenic participants, comparable to schizophrenia patients in age, gender, education level and socio premorbid verbal IQ. | Behavioral: Theory of mind without visual cues<br>* Theory of mind stimulation without visual reinforcement while performing EEG recordings<br>Behavioral: Theory of mind without visual cues<br>* Theory of mind stimulation with visual reinforcement while performing EEG recordings<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event related electric amplitudes | Scalp EEG recordings (microvolts) with respect to average or vertex references | Day 0 |
Visual Pain Score and Perfusion Index in Postoperative Patients

Study Overview
=================
Brief Summary
-----------------
The relationship between visual pain score and perfusion index in postoperative patients.

Detailed Description
-----------------
The patients' operated with general anesthesia and who had visual pain score(VAS) above 3 will be measured postoperatively perfusion index. .If the VAS score is above 3, 2 mg of morphine will be made. When the VAS score is below 3, the perfusion index will be measured again.Thus, the changes between vas and perfusion index will be measured.

Official Title
-----------------
The Relationship Between Visual Pain Score and Perfusion Index in Postoperative Patients

Conditions
-----------------
Perfusion

Intervention / Treatment
-----------------
* Drug: Morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent surgery with general anesthesia Exclusion Criteria: Patients with caesarean section, pregnancy story and chronic pain

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Morphine<br>patients with the visual analog scale over 3 will receive morphine | Drug: Morphine<br>* patients with the visual analog scale over 3 will receive morphine<br>* Other names: opioid analgesic;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfusion index Perfusion index | Measurement of perfusion on the right ring finger | two times in one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale | measurement of pain intensity | two times in one day |
Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function

Study Overview
=================
Brief Summary
-----------------
The technological progress allowed the development of more and more sophisticated pacemakers, widening the therapeutic indications but also meeting the physiological needs of the patient. This progress led to a more and more complex programming for the physicians. To help them set optimally the pacing parameters, physicians refer to the existing recommendations of learned societies as well as to his expertise. Manufacturers developed also algorithms integrated into pacemakers with the aim of assisting physicians in their programming. TherapyGuide is a function which proposes a programming adapted to the psychopathological state of the patient, with a justification based on experts' consensus, clinical studies as well as on published articles. Physicians have the choice to accept or reject the programming proposed by TherapyGuide. When rejected, there is no means to analyze the modifications brought to the proposed set of parameters. The nature, the frequency and the reasons of these modifications are not thus known. The purpose of this study is to assess the acceptance of the TherapyGuide proposals by physicians and to identify the most frequent type of programming changes they make and their rationale.

Official Title
-----------------
TherapyGuide : Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function

Conditions
-----------------
Bradyarrhythmia

Intervention / Treatment
-----------------
* Device: TherapyGuide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient implanted with a pacemaker featuring the TherapyGuide function Patient more than 18 years of age. Patient able to sign a data release authorization form Exclusion Criteria: - Unwillingness or inability to provide written 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TherapyGuide<br>Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function | Device: TherapyGuide<br>* Use of TherapyGuide function to help programming the device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance of TherapyGuide Proposals and Typology of Programming Changes | The primary objective is to assess the acceptance of the TherapyGuide proposals by the physicians. Acceptance will be assessed by measuring the proportion of cases where physicians programmed the set of parameters recommended by the TherapyGuide with no modifications. | 30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pacemaker programming, Bradyarrhythmia
Black Cohosh Extract for Treatment of Moderate to Severe Menopausal Symptoms

Study Overview
=================
Brief Summary
-----------------
Compare the treatment efficacy of black cohosh extract 80 mg daily and placebo for moderate to severe menopausal symptoms

Detailed Description
-----------------
Compare the treatment efficacy of black cohosh extract 80 mg/day an placebo for moderate to severe menopausal symptoms with Kupperman menopausal index and MENQOL

Official Title
-----------------
Black Cohosh Extract for the Treatment of Moderate to Severe Menopausal Symptoms: a Randomized-placebo Controlled Trial

Conditions
-----------------
Menopause, Quality of Life

Intervention / Treatment
-----------------
* Drug: black cohosh extract
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at least 40 years Peri or post menopause Moderate to severe menopausal symptoms (Kupperman index at least 20) Exclusion Criteria: Use hormonal treatment or other treatments within 4 weeks Use atorvastatin azathioprine or cyclosporin within 4 weeks BMI at least 30 kg m2 Allergic to drug or components Liver disease or abnormal liver function test Psychiatric disease Alcoholic or drug abuse Vegetarian

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Black cohosh extract<br>black cohosh extract 80 mg daily | Drug: black cohosh extract<br>* Black cohosh extract 80 mg<br>* Other names: Femosa;|
| Placebo Comparator: Placebo<br>Matching placebo | Drug: Placebo<br>* Soy bean oil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in Kupperman Index | Kupperman index questionnaire at baseline, 4, 8 and 12 weeks | baseline, week 4, week 8 and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change in MENQOL | MENQOL questionnaire measurement at baseline and 12 weeks | baseline and week 12 | 
| The changes in daily hot flushes frequency | Daily hot flushes frequency over 12 weeks treatment | baseline, week 4, week 8 and week 12 | 
| Global satisfaction | Overall patient satisfaction 0 - 10 scale | week 12 | 
| A change in liver function test | Changes in liver function test from baseline and 12 weeks | baseline and week 12 | 
| adverse events | frequency of adverse events | week 4, week 8 and week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopausal symptoms, menopause related quality of life, black cohosh, cimicifuga racemosa, MENQOL, Kupperman index, KI, liver function tests
Research Of Quality Of Life And Safety Outcomes Of Postmenopausal Breast Cancer Patients Switching From Tamoxifen Therapy To Aromatase Inhibitor Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to follow safety and quality of life outcomes on patients switching from tamoxifen therapy to aromatase inhibitor therapy.

Detailed Description
-----------------
Group of patients using the same aromatase inhibitor

Official Title
-----------------
A Non-Interventional Study Evaluating The Effects Of Aromatase Inhibitor Treatment After 2-3 Years Tamoxifen - As Adjuvant Endocrine Therapy - On Quality Of Life And Safety In Endocrine Responsive Early Stage Postmenopausal Breast Cancer Patients

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Other: Aromatase inhibitors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with endocrine responsive early stage postmenopausal breast cancer. Patients who received tamoxifen for 2-3 years as adjuvant endocrine therapy. Patients who were approved to switch to aromatase inhibitor treatment during the patient recruitment period. Patients who were informed about the study and accepted to participate. Exclusion Criteria: Patients having a psychological disorder which will prevent their understanding of questionnaires used for evaluation of quality of life and / or patients who are illiterate.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aromatase inhibitors<br>Early stage postmenopausal breast cancer patients under tamoxifen treatment who are switching to aromatase inhibitor treatment | Other: Aromatase inhibitors<br>* non-interventional study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the quality of life of patients with early stage postmenopausal breast cancer using aromatase inhibitor following 2-3 years of tamoxifen treatment (switch) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate patients with early stage postmenopausal breast cancer using aromatase inhibitor following 2-3 years of tamoxifen treatment (switch) in terms of side effects |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aromatase inhibitor, quality of life, safety, postmenopausal breast cancer
Post-marketing Safety Surveillance Program in Human Immunodeficiency Virus (HIV)-Infected Children Exposed to Atazanavir in Europe

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor adverse events in HIV-infected children <18 years old who are exposed to Atazanavir in a real-world setting in Europe.

Official Title
-----------------
Post-marketing Safety Surveillance Program in HIV-infected Children Exposed to Atazanavir in Europe

Conditions
-----------------
HIV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected children participating in individual prospective paediatric HIV cohorts Receive Atazanavir treatment during 01JAN2011 to 30DEC2013 Age <18 years old on the date starting an Atazanavir-containing regimen Have a minimum of 3 months of follow-up

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- |
| HIV-infected children <18 yrs old - exposed to Atazanavir<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse events reported during Atazanavir drug exposure | Timeframe of the study | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pattern of use of Atazanavir | Atazanavir dosage administered, treatment duration (date started, date stopped), reason for dosage adjustment, withdrawal and reason for withdrawal, Ritonavir dose, other antiretroviral drug use, and other concomitant medications | 12-months | 
| Pattern of use of Atazanavir | Atazanavir dosage administered, treatment duration (date started, date stopped), reason for dosage adjustment, withdrawal and reason for withdrawal, Ritonavir dose, other antiretroviral drug use, and other concomitant medications | 24-months | 
| Pattern of use of Atazanavir | Atazanavir dosage administered, treatment duration (date started, date stopped), reason for dosage adjustment, withdrawal and reason for withdrawal, Ritonavir dose, other antiretroviral drug use, and other concomitant medications | 36-months |
Imaging of T-cell Activation With [18F]F-AraG in Advanced Non Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This is a pilot study using [18F]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors at multiple study sites. The main objectives of the study are to quantify the change in [18F]F AraG PET signal before and after CkIT therapy, and to correlate this change in [18F]F AraG PET signal with a radiographic response.

Detailed Description
-----------------
Approximately 50 patients will undergo two research PET/CT scans with [18F]F AraG at two time points. Each patient will receive two 5 (+/-10%) mCi doses of [18F]F AraG, one for each imaging time point. Eligible subjects will undergo a pre-treatment [18F]F AraG PET/CT scan within 7 days prior to treatment, followed by treatment, and an on-treatment [18F]F AraG PET/CT within 7-14 days of treatment. Objectives: Quantify [18F]F-AraG uptake in advanced NSCLC tumor (primary, nodal, and metastatic sites) at baseline and after 1 dose of anti-PD-1/PD-L1 therapy in patients treated with standard of care immunotherapy (as monotherapy or part of combination therapy). Correlate change in [18F]F AraG uptake in tumor lesions with radiographic response.

Official Title
-----------------
Imaging of T-cell Activation With [18F]F-AraG in Advanced Non Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1 Directed Therapy

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: [18F]F AraG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy with concurrent as treatment for advanced/metastatic disease. RECIST measurable disease. ECOG performance status of 0, 1 or 2. Life expectancy >/= 6 months at enrollment. Exclusion Criteria: Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives. Pregnant women or nursing mothers. Patients with severe claustrophobia.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: [18F]F AraG|PET imaging agent specific to activated T cells|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [18F]F-AraG uptake signal | [18F]F-AraG uptake signal will be measured quantitatively by SUV-bw of the tumor volumes of interest before and after undergoing treatment | two years |
The Relationship Between the Surgery-related Anxiety and HRV: Prediction for Aggressive Emergence Behavior

Study Overview
=================
Brief Summary
-----------------
Heart rate variability (HRV) is known to reflect the balance of autonomic nervous system. Anxiousness, which tend to result from the deficient action of parasympathetic nervous system, likely to show low HRV. This study is to investigate the relationship between the surgery-related anxiety and the HRV which is known to reflect the balance of autonomic nervous system. Furthermore, this study also focuses on HRV's role as a predictor for aggressive emergence behavior, which might also be considered as partially related to imbalance of autonomic nervous system.

Conditions
-----------------
Closed Reduction Surgery for Nasal Bone Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-60 years old male, ASA 1-2 scheduled for elective closed reduction for nasal bone fracture Exclusion Criteria: Patients having hearing difficulties, Foreigner, taking any CNS related medication, history of any adverse drug reaction, Glasgow coma scale < 15 patients with severe cardiopulmonary dysfunction patients taking any neurologic medication (anti-depressant, anti-convulsant, etc) patients taking any cardiovascular medication patients taking medications affecting the autonomic nervous system (a-blocker, b-blocker, etc) patients refusal

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Visual analogue scale (VAS) >5<br>The degree of surgery-related anxiety assessment using VAS | |
| Visual analogue scale (VAS) ≤5<br>The degree of surgery-related anxiety assessment using VAS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High frequency (HF) of Heart Rate Variability (HRV) | High frequency (HF) component of HRV, which represents the parasympathetic activity | from immediately after tracheal intubation to 5 min after tracheal intubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emergence agitation, Heart rate variability (HRV)