linjc16/ctgov huggingface dataset:
Facial Yoga Toning Program - A Pilot Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the efficacy of a facial yoga exercise program on appearance and to measure patient satisfaction with facial yoga practice.

Detailed Description
-----------------
This is a single center prospective longitudinal pilot study of 27 subjects. The study will include 20 study subjects and 7 controls. Participants in this study will be healthy subjects 18 years and older with mild to moderate facial atrophy without a history of surgical or non-surgical treatment to the area. The study subjects will perform facial yoga and apply sunscreen (Neutrogena Helioplex SPF 55) daily. The controls will apply sunscreen alone daily for 8 weeks.

Official Title
-----------------
Facial Yoga Toning Program - A Pilot Study

Conditions
-----------------
Facial Atrophy Related to Age

Intervention / Treatment
-----------------
* Procedure: Facial Yoga Toning Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over age 18 years Exclusion Criteria: pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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: Facial Yoga Toning Program<br>Patients will be instructed on 18 exercises which are intended to strengthen and tone the muscles of facial expression. DVD is provided. | Procedure: Facial Yoga Toning Program<br>* Patients will be instructed on 18 exercises which are intended to strengthen and tone the muscles of facial expression. DVD is provided.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of facial yoga toning program on aesthetic appearance | subjects will be photographed and investigator will complete Global Aesthetic Improvement Scale to document results at baseline, 2, 4, 6, and 8 weeks | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subject satisfaction with facial yoga toning program | subjects will complete satisfaction survey at baseline, 2, 4, 6, and 8 weeks | 8 weeks |
Study of Valproate in Young Patients Suffering From Epilepsy

Study Overview
=================
Brief Summary
-----------------
Main objective: Therapeutic follow-up study Evaluate the clinical and biological safety of valproate administered as microgranules, under standard prescription conditions, with therapeutic follow-up and individual dosage adjustment, using valproate plasma concentrations and antiepileptic comedication as well as biological assays. Secondary objectives: Ancillary population kinetics study Estimate the pharmacokinetic parameters of valproate administered as microgranules under standard therapeutic conditions within the population studied, from the therapeutic follow-up data. Evaluate the influence of individual characteristics on the pharmacokinetic parameters. Describe the relationship between plasma concentrations and adverse events for valproate and the main anti-epileptic comedications.

Official Title
-----------------
Therapeutic Follow-up Observational Study and Population Kinetics Ancillary Study of Valproate Microgranules (Micropakine® SR) in Patients Aged Between 6 Months and 15 Years Suffering From Epilepsy.

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: valproate microgranules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged between 6 months and 15 years. Suffering from any type of epilepsy. Receiving at the time of inclusion valproate in the form Micropakine® SR 20 to 30 mg/kg/d by oral route, in 2 daily administrations and at most two other antiepileptic drugs (an antiepileptic benzodiazepine treatment taken daily or on demand more than 2 times weekly, must be considered as an antiepileptic treatment). Followed by hospital paediatricians or neuropaediatricians. For whom the consent has been signed by the parents or the holders of parental authority and if possible by the child him/herself. For whom the parents or legal guardian do not have any language or cultural obstacle for understanding the study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 15 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: valproate<br> | Drug: valproate microgranules<br>* 20 to 30 mg/kg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and biological safety. |  | at each visit | 
| Pharmacokinetic parameters and covariables likely to explain the variability in the pharmacokinetic parameters of valproate |  | Ancillary population kinetics study |
Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD

Study Overview
=================
Brief Summary
-----------------
Facioscapulohumeral muscular dystrophy (FSHD) is the second most common muscular dystrophy with approximately 500 patients in Denmark. It is characterized by weakness and wasting of the facial muscles, the muscles in the shoulder region and of the legs. The primary aim of this study is to investigate possible links and order between inflammation and fat infiltration in the muscles in patients with FSHD. Approximately 15 patients with FSHD will be recruited for repeated MRI-scans during a year where the inflammation and fat infiltration in the muscles can be quantified.

Official Title
-----------------
Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD

Conditions
-----------------
Facioscapulohumeral Muscular Dystrophy 1a

Intervention / Treatment
-----------------
* Other: No intervention, observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed FSHD Exclusion Criteria: All contraindications for undergoing an MRI scan

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 |
| --- | --- |
| Patient group<br>Patients over 18 years old with confirmed FSHD (facioscapulohumeral muscular dystrophy). | Other: No intervention, observational<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle inflammation | MRI (t2 mapping) will be used to quantify the inflammation in skeletal muscle. | One MRI scan per subject (exam lasts approximately 60 min.) | 
| Muscle fat fraction | The Dixon MRI will be used to quantify the fat fraction in skeletal muscle. | One MRI scan per subject (exam lasts approximately 60 min.) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | Isokinetic muscle dynamometry will be used to measure muscle strength. | One muscle strength test per subject (exam lasts approximately 60 min.) |
Colistin Versus Colistin Plus Fosfomycin for Infections Caused by MDR Acinetobacter Baumannii

Study Overview
=================
Brief Summary
-----------------
In Siriraj Hospital, colistin alone for treatment of MDR A. baumannii contributed to mortality 45% Fosfomycin is an antimicrobial which has activity against gram-negative bacterial including MDR A. baumannii In this study, we compare the clinical and microbiologicalresponse of colistin alone versus colistin plus fosfomycin in treatment of A. baumannii infected patients

Detailed Description
-----------------
Inclusion criteria Age> 18 years Hospitalized to Siriraj Hospital Infected caused by A. baumannii Need Colistin treatment Exclusion criteria Pregnancy or Lactating mother Colistin or Fosfomycin Allergy Patients who have severe abnormal renal or liver function

Official Title
-----------------
Colistin Plus Fosfomycin in Multi-Drug Resistant Acinetobacter Baumannii

Conditions
-----------------
Drug Safety

Intervention / Treatment
-----------------
* Drug: colistin
* Drug: colistin plus fosfomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 years Hospitalized to Siriraj Hospital Infected caused by A. baumannii Need Colistin treatment Exclusion criteria: Pregnancy or Lactating mother Colistin or Fosfomycin Allergy Patients who have severe abnormal renal or liver function

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 |
| --- | --- |
| Active Comparator: colistin<br>Colistimethate sodium 2.5-5mg/kg iv | Drug: colistin<br>* Colistimethate sodium 2.5-5mg/kg of colistin base<br>* Other names: Colistate;|
| Active Comparator: colistin plus fosfomycin<br>colistimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours | Drug: colistin plus fosfomycin<br>* colitimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours<br>* Other names: Fosmicin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of subjects with cure or improvement | cure improvement worse death | up to 28days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of subjects with eradication of causative bacteria | eradication persistence superinfection | up to 28days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
A. baumannii, colistin, fosfomycin
Physical Exercise as a Targeted Therapy in Patients With Chronic Rheumatic Muscle Inflammation

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to test if hypoxia in muscle tissue is an important factor contributing to clinical symptoms in chronic rheumatic muscle inflammation and to evaluate if a 12 week endurance exercise program will improve muscle tissue hypoxia and disability in patients with chronic rheumatic muscle inflammation.

Official Title
-----------------
Physical Exercise as a Targeted Therapy in Patients With Chronic Rheumatic Muscle Inflammation

Conditions
-----------------
Myositis

Intervention / Treatment
-----------------
* Other: Physical Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic, stable polymyositis or dermatomyositis with diagnosis of definite or probable polymyositis or dermatomyositis (Bohan and Peter 1975) Age 18-80 years Duration since diagnosis > 6 months Exercising < once a week, Stable disease activity and medication for at least one month. Ten healthy controls matched for age, gender and physical exercise level will be included. - Exclusion Criteria: Severe pulmonary fibrosis Heart or lung conditions that contraindicate vigorous exercise Severe osteoporosis Not being able to perform the exercise program.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br> | Other: Physical Exercise<br>* 12 weeks of physical exercise.<br>|
| No Intervention: No intervention<br>12 weeks of stable physical exercise level. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxia related metabolites. |  | At baseline before intervention. | 
| Hypoxia related metabolites. |  | After 12 weeks of endurance exercise intervention/ non intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle impairment. |  | At baseline before intervention. | 
| Muscle impairment. |  | After 12 weeks of endurance exercise intervention/ non intervention. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myositis, Physical exercise, Disability
The Link Between Anemia and Deficits in Memory and Attention in Individuals With Sickle Cell Disease

Study Overview
=================
Brief Summary
-----------------
Sickle cell disease is an inherited blood disorder that affects red blood cells (RBCs). People with sickle cell disease frequently experience anemia, or a low number of RBCs. RBCs are responsible for carrying oxygen to the brain and other body tissues that need oxygen to function properly. The purpose of this study is to determine what changes, which were possibly caused by anemia, exist in the brains of individuals with sickle cell disease.

Detailed Description
-----------------
The role of RBCs is to carry oxygen from the lungs to the brain and other body tissues. Individuals with anemia have unusually low numbers of RBCs. They also often have difficulty concentrating and remembering information, which is likely caused by a reduced oxygen supply to the brain. Previous research has shown that correcting anemia in patients without sickle cell disease improved their memory and attention. The purpose of this study is to examine any abnormal changes in the brains of individuals with sickle cell disease and to determine whether these changes are related to reduced memory and attention capabilities. Participants will attend one study visit. During this visit, a brain magnetic resonance image (MRI) will be performed while participants complete neuropsychological tests that measure memory, attention, and organizational ability. There will be no follow-up visits. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Official Title
-----------------
Sickle-Cell Disease: Neuroimaging and Cognitive Decline

Conditions
-----------------
Sickle Cell Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of sickle cell disease Exclusion Criteria: Pregnancy Claustrophobia Mass lesion (e.g., meningioma, cyst, or spinal block) Need for life support constant monitoring Any unstable condition that is likely to require resuscitation Presence of a pacemaker or other iron-containing magnetic substances in the body

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Neuropsychology
Assessment of Patient Frailty Prior to Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
Determine the feasibility of assessment of measures of frailty and determine if these measures provide a clinically important contribution of risk assessment in a population of patients undergoing major thoracic surgery for lung or esophageal cancer.

Detailed Description
-----------------
Both gastro-esophageal and lung cancers are major causes of morbidity and mortality worldwide. In Canada the incidence for Esophageal Adenocarcinoma has doubled in the last two decades, while lung cancer is the leading cause of cancer death. Surgery is a treatment option for these patients; however, esophagectomy in particular, is associated with significant morbidity, mortality and adverse effect on quality of life. Despite satisfactory standard preoperative testing to evaluate risk for surgery, some patients experience morbidity and never recover fully from surgery. Frailty assessment may offer a more sensitive measure of a patient's physiologic reserve, which may allow identification of patients who are poor candidates for surgery. There is a lack of consensus of how best to assess frailty prior to surgery. This study aims to analyze frailty assessment as a tool for patient selection for surgery.

Official Title
-----------------
Assessment of Patient Frailty Prior to Thoracic Surgery: A Feasibility Study

Conditions
-----------------
Lung Cancer, Esophageal Cancer

Intervention / Treatment
-----------------
* Other: Frailty Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Esophageal or Lung Cancer who will undergo resectional surgery. Exclusion Criteria: Patients undergoing diagnostic or staging procedures or pulmonary wedge excisions will be excluded. Patients unable to give 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung Cancer - Frialty Assessment<br>Patients who will undergo surgery for lung cancer | Other: Frailty Assessment<br>* Various physiologic and frailty assessment tests<br>|
| Esophageal Cancer - Frailty Assessment<br>Patients who will undergo esophagectomy for esophageal cancer | Other: Frailty Assessment<br>* Various physiologic and frailty assessment tests<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility Assessment | Determine the feasibility of assessment of measures of frailty and determine if these measures provide a clinically important contribution of risk assessment in a population of patients undergoing major thoracic surgery for lung or esophageal cancer. | 2 years |
Rates of Apnea in Patients Undergoing Vitreoretinal Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if apnea (the stopping of breathing) occurs in patients undergoing undergoing monitored anesthesia care (MAC) for vitreoretinal surgery

Detailed Description
-----------------
Patients undergoing vitreoretinal surgery will be monitored during the procedure to determine if they stop breathing. This study is observational in nature and no interventions will be made.

Official Title
-----------------
Rates of Apnea in Patients Undergoing Vitreoretinal Surgery

Conditions
-----------------
Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients having vitreoretinal surgery under monitored anesthesia care Exclusion Criteria: patients having vitreoretinal surgery without monitored anesthesia care

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| vitreoretinal surgery patients<br>Patients undergoing vitreoretinal surgery under monitored anesthesia care. They will be observed during surgery and no interventions will be administered. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea | Determine if patients undergoing vitreoretinal surgery under monitored anesthesia care stop breathing during the procedure | 15 minutes |
Relationship of CP and AP

Study Overview
=================
Brief Summary
-----------------
The present study aimed to determine the prevalence of AP attacks before the diagnosis of CP and further identified the potential associated factors for AP episodes.

Official Title
-----------------
The Prevalence of Acute Pancreatitis Episodes Among Patients With Chronic Pancreatitis and the Associated Factors

Conditions
-----------------
Chronic Pancreatitis, Acute Pancreatitis

Intervention / Treatment
-----------------
* Other: patients' characteristics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consequent patients with a diagnosis of CP between January 2010 to December 2015 informed consents provided Exclusion Criteria: autoimmune pancreatitis (AIP) pancreatic cancer diagnosed within 2 years after the diagnosis of CP
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: patients' characteristics|There was no intervention.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the occurrence of acute pancreatitis | the presence and frequency of acute pancreatitis before diagnosis of CP | Baseline (before the diagnosis of CP) |