linjc16/ctgov huggingface dataset:
Individualization of Music-based Cueing During Gait in Parkinson's Disease.

Study Overview
=================
Brief Summary
-----------------
Spatio-temporal correction of the step is a key component of gait rehabilitation in Parkinson's disease. Walking rehabilitation techniques using visual or auditory cueing of the cadence or step length have been tested to prevent or correct the lack of consistency of the step. An auditory cue of the duration of the step, encouraging it to be extended according to patient own capacities during gait has been proposed. The cue is integrated into music and is presented in an open-loop approach. The present study aimed to evaluate the effect of the individual music-based cueing of the step length on gait in Parkinson's disease.

Official Title
-----------------
Individualization of Music-based Cueing During Gait in Parkinson's Disease. An Exploratory Cross-over Trial

Conditions
-----------------
Gait Disorders, Neurologic, Parkinson Disease

Intervention / Treatment
-----------------
* Other: Gait training with musical cue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Idiopathic Parkinson's disease based on UKPDSBB criteria 10-meter walking comfortable speed between 0,30 and 1,10 m/s Capacities to walk with shoes during at least 20 minutes without assistance Signature of informed consent Exclusion Criteria: Non-affiliation to Social Security Person under protection (e.g. under protection of justice) Auditory disorders without treatment Cognitive disorders that limit the understanding of the study according to the medical investigator Other neurological or orthoêdic disorders that addect walking Participating in another Category 1 or 2 interventional clinical study for the duration of the trial

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: Persons with moderate idiopathic Parkinson's disease<br> | Other: Gait training with musical cue<br>* Entraînement de 20 minutes de marche à vitesse confortable sur un parcours ovale de 20 mètres au laboratoire ARM avec la technique d'indiçage musical personnalisé de la longueur de pas.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Step length | Step length during confortable gait over 8 meters | Before and just after the intervention (day 1) |
Iclusig® (Ponatinib) in Clinical Practice for the Treatment of Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia in Belgium

Study Overview
=================
Brief Summary
-----------------
This prospective registry is initiated to follow up on the use of Iclusig® in patients with CML or Ph+ ALL in routine practice in Belgium.

Official Title
-----------------
Prospective Registry of Iclusig® (Ponatinib) Used in Clinical Practice for the Treatment of Patients With Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia in Belgium

Conditions
-----------------
Chronic Myeloid Leukemia, CML, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia, Ph+ ALL

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with confirmed diagnosis of: CML (chronic, accelerated or blast phase) who is resistant or intolerant to dasatinib or nilotinib; and for whom subsequent treatment with imatinib is not clinically appropriate; or who has the T315I mutation. Ph+ ALL who is resistant or intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who has the T315I mutation. Patients on treatment with Iclusig® or prescribed for treatment with Iclusig® during the registry (treatment decisions should be taken outside the registry). Written informed consent obtained from the patient, if still alive (NPP participants that were still on Iclusig® treatment on 01 March 2016, but who died before the start of this registry will be included without informed consent provided that a waiver is granted by the ethics committee for inclusion of these patients). Exclusion Criteria: • Concurrently participating in a clinical study, at any time during the registry period, in which the patient is exposed to Iclusig® or to another investigational product/ vaccine (pharmaceutical product/ device).

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 |
| --- | --- | --- |
| Prescribed dose of Iclusig® in routine practice in Belgium | Prescribed dose of Iclusig® in milligrams. | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall clinical benefit rate of Iclusig® based on response criteria for CML or Ph+ ALL in Belgium | Includes treatment effectiveness, complete hematologic response, cytogenetic response, major molecular response. | Up to 3 years | 
| Estimate of additional health care utilization cost | Costs associated with the treatment of Iclusig®-related adverse events reported during the registry. | Up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic myeloid leukemia, Philadelphia chromosome positive acute lymphoblastic leukemia, Iclusig®, ponatinib
Relationship Between D2 Receptors SPECT and the Apomorphine Test in Patients With OH Dependence (ALC-DRD2-APO)

Study Overview
=================
Brief Summary
-----------------
OH dependence is associated with DA receptor changes. Both, the apomorphine test and the D2Rec SPECt are usefull for monitoring DA receptor status. We aimed at studying whether DA receptor hypofunction, assessed by means of the apomorphine test and the D2Rec SPECT, is a marker of relapse in detoxified OH dependents patients.

Official Title
-----------------
Relationship Between D2 Receptors SPECT and the Apomorphine Test in Patients With OH Dependence: Predictive Value for Relapse

Conditions
-----------------
Alcoholism

Intervention / Treatment
-----------------
* Drug: apomorphine
* Drug: [(123)I] iodobenzamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: alcohol dependence alcohol dependence length at least 8 years. male age 25 - 60 years Exclusion Criteria: other drug dependence (except nicotine dependence) another major axis I psychiatric diagnosis comorbid neurological disorder comorbid cardiovascular disorder comorbid metabolic disorder brain injury apomorphine allergy iode allergy diazepam allergy

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: apomorphine|Apomorphine 0.05 mg/kg subcutaneously at hospital admission and at discharge. Abstinent participants at 3 months will receive a third dose.|
|Drug: [(123)I] iodobenzamide|[(123)I] iodobenzamide 185 MBq I.V., at discharge.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To detertmine the agreement rate of the dopaminergic sensibility assessed by two different techiniques: the apomorphine test and and IBZM SPECT. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alcoholism, apomorphine, iodobenzamide, imaging, spect, relapse
Validation and Field Test for Risk Appraisal Instruments

Study Overview
=================
Brief Summary
-----------------
To field test the validity, reliability, cost, and cost-benefit of Health Risk Appraisal (HRA) instruments.

Detailed Description
-----------------
BACKGROUND: Health Risk Appraisals instruments have provided the field of health promotion with an imaginative motivational and instructional tool to foster personal behavioral change. A HRA typically asked questions about smoking, blood pressure, exercise, medical history, diet and other life style variables. These risk indicators were then compared to epidemiological and mortality data to yield an estimate of an individual or group's risk for disease. They were widely regarded as the most promising new addition to the health promotion armamentarium. The National Health Information Clearinghouse divided them into the following three categories: Computer-Scored HRAs, which were mailed to a central computer facility for batch processing and were usually the more complex and detailed appraisals; Microcomputer-Based HRAs, which c;ould be processed by a microcomputer at home, in schools or at the worksite; and Self-Scored HRAs, which were usually brief, did not involve a computer, and were scored by the user. Although HRAs were a burgeoning industry in health education, no properly designed and conducted scientific evaluation of them on a sufficiently large and representative sample of the general population had been undertaken in the United States or elsewhere. DESIGN NARRATIVE: In the first stage, fourteen HRAs were evaluated by determining the validity of the scoring system for estimating cardiovascular risk as employed in the Framingham Heart Study data base, the accuracy of the reported risk factor scores as measured by physiological values, and the understandability and social acceptability of the instrument format. The second stage of the project was a field test to determine reliability and cost-effectiveness. Ten groups of respondents were formed by randomly assigning eligible adults to one of the five HRA groups and then to reliability and validity status. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Coronary Heart Disease Risk Reduction

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

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Prevalence and Clinical Characteristics of Patients With Jackhammer Esophagus and Symptoms of Gastroesophageal Reflux Disease

Study Overview
=================
Brief Summary
-----------------
Gastroesophageal reflux disease (GERD) is involved in the development of esophageal motility disorders like Jackhammer esophagus (JE), a novel hypercontractile condition that was associated with progression to achalasia and limited outcomes following surgical anti-reflux therapy. This trial was designed to assess the prevalence and characteristics of JE in patients with typical symptoms of GERD and responsiveness to PPI therapy.

Detailed Description
-----------------
Jackhammer esophagus is a novel hypercontractile esophageal disorder. The investigators assess the prevalence and clinical characteristics of patients diagnosed with this disorder out of a collective of patients that are referred with symptoms of gastroesphageal reflux disease and respond to PPI. This is an observational trial.

Official Title
-----------------
Prevalence and Clinical Characteristics of Patients With Jackhammer Esophagus and Symptoms of Gastroesophageal Reflux Disease

Conditions
-----------------
Esophageal Motility Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptoms of gastroesophageal reflux disease and diagnosis of Jackhammer esophagus Exclusion Criteria: patients not willing to participate data or undergo screening for gastroesophageal reflux disease

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Jackhammer esophagus in patients referred with symptoms of gastroesophageal reflux disease | All patients that are referred to our center with symptoms of gastroesophageal reflux disease routinely undergo high-resolution manometry. We assess how many patients are diagnosed with Jackhammer esophagus | January 2014- May 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom perception | We assess which symptoms are perceived by the patients diagnosed with Jackhammer esophagus. All data are observed during an interview at the high-resolution manometry | January 2014- May 2017 | 
| Prevalence of gastroesophageal reflux disease in patients with Jackhammer esophagus | All patients that are referred to our center are evaluated for gastroesophageal reflux disease. We assess the prevalence of gastroesophageal reflux disease in patients with Jackhammer esophagus diagnosed by ambulatory pH monitoring. | Januar 2014- May 2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophagus, motility
Glutamatergic Amino Acids and Oxytocin Levels in the Plasma of Patients in First Psychotic Episode (FPE)- Before and After Neuroleptic Treatment

Study Overview
=================
Brief Summary
-----------------
The goal of our research is to check the levels of D-Serine, Glycine, and other Glutamatergic amino acids, in patients with First Psychotic Episode (FPE). These patients are in the early stage of the disease, treated with neuroleptics for short periods of time, and are usually hospitalized for the first time. The hypothesis of the research is that we will find low levels of Glycine and D-Serine in these patients. Following an Anti-psychotic treatment we will expect these levels to return to the norm, and that this correction will be accompanied by a reduction of positive and negative symptoms. In addition, we will check the D-Serine and Glycine levels in the plasma of first degree relatives of the patients and a group of healthy subjects. The results of this study might support the hypothesis that the Glutamatergic system in involved in the pathology of Schizophrenia from it's early stages. In addition, we will check the levels of Oxytocin and Estrogen in the plasma of patients in FPE. Our hypothesis is that we will find low levels of Estrogen and High levels of Oxytocin in this group of patients. The results of the study might support the hypothesis that Estrogen and Oxytocin are involved in the pathology of Schizophrenia from it's early stages.

Conditions
-----------------
Schizophrenia, Schizophreniform, Schizoaffective Disorder, Brief Psychotic Episode

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects between 18-60 years Clinical Diagnosis of Schizophrenia, Schizophreniphorm disorder, Schizoaffective Disorder, Brief esychotic episode Exclusion Criteria: two years or more of positive symptoms Neuroleptic treatment for more then twe weeks in the prior month, or for more then six weeks at any time. Drug induced psychotic episode

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>40 subjects in a First Psychotic Episode | |
| 2<br>20 First Degree relatives | |
| 3<br>20 Healthy subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycine and D-Serine levels in the plasma. |  | 6-8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
First-Psychotic-Episode (FPE), Glutamatergic system, Glycine, D-Serine, Oxytocin, Estrogen
Interactive Motor Imagery in Virtual Reality

Study Overview
=================
Brief Summary
-----------------
This project will build and test the first rehabilitation system employing virtual reality (VR)-based observation, motor imagery and execution to treat lower-limb neuropathic pain and motor dysfunction in participants with an incomplete spinal cord injury or another neurological disorder, eg. stroke: iCTuS-L (Interactive Computer-based Therapy System for legs). Patients using the system will control virtual representations of their legs to engage in entertaining gaming interactions.

Conditions
-----------------
Spinal Cord Injury, Stroke

Intervention / Treatment
-----------------
* Device: iCTuS-L


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 16 and 80 clinically incomplete spinal cord injury (time since injury: chronic > 1 year; acute < 3 months) ASI C or D neuropathic pain and/or motor deficits diagnosed neurological disorder, eg. stroke Exclusion Criteria: any disease limiting training epilepsy major depression or psychosis

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation<br> | Device: iCTuS-L<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensorimotor Assessment | Questionnaire assessing distinct pain qualities associated with neuropathic pain, structured pain interview, questionnaire for assessing patients diagnosed as depressed and detects depression among the normal population, transcutaneous electrical stimulation of superficial nerves, information about the motor level of the lesion, the sensory levels of the lesion (light touch and pin prick), questionnaire assessing activities of daily life and independence in subjects with spinal cord lesion, walking aids and/or personal assistance, examining gait speed, transcranial magnetic stimulation | 16 weeks |
Evaluation of Breast Cancer Surgical Margins Using Optical Spectroscopy

Study Overview
=================
Brief Summary
-----------------
This study will apply optical spectroscopy to intraoperative margin assessment during surgery for breast cancer. We hypothesize that a combination of fluorescence spectroscopy and diffuse reflectance spectroscopy will reliably detect involved surgical margins. Twenty patients with ductal carcinoma in-situ will undergo a standard lumpectomy followed by scanning with a sterile optical spectroscopy probe. Frozen sections from the surgical cavity will be used to evaluate the margins. Optical spectroscopy data will be categorized as benign or malignant using a statistical algorithm and the results will be compared with the frozen and permanent section results.

Official Title
-----------------
A Pilot Study of Intraoperative Margin Assessment Comparing Optical Spectroscopy and Frozen Section Analysis for Ductal Carcinoma In Situ of the Breast

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: fluorescence spectroscopy and diffuse spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ductal carcinoma in-situ or invasive carcinoma diagnosed by image directed core biopsy who are planning to undergo breast conserving surgery Exclusion Criteria: patients who were diagnosed with excisional biopsy and patients undergoing mastectomy

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: fluorescence spectroscopy and diffuse spectroscopy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The goal of this research is to develop a minimally invasive technology with the capability of rapidly assessing surgical margins for breast cancer patients undergoing breast conserving therapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two potential benefits from developing this technology are: |  |  | 
| 1. Decreasing operative times by eliminating the need to wait for histologic margin assessment. |  |  | 
| 2 Intraoperative margin assessment will become available for surgeons performing breast conserving therapy in facilities in-house pathologists. |  |  |