linjc16/ctgov huggingface dataset:
Clinical Study of Xingnaojing for the Treatment of Convulsive Diseases

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of Xingnaojing for the treatment of convulsive diseases; to investigate whether convulsion episodes can be induced or aggravated by Xingnaojing and the role inflammation plays in the process.

Official Title
-----------------
Clinical Study of Xingnaojing for the Treatment of Convulsive Diseases

Conditions
-----------------
Convulsive Diseases

Intervention / Treatment
-----------------
* Drug: Xingnaojing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Febrile convulsion: positive family history of febrile convulsion; aged between 6 months and 6 years old; in accordance with the diagnosis criteria of simple type of febrile convulsion Frequent episodes of epilepsy: epilepsy episodes of all types; > 3 times / week Refractory epilepsy: no satisfactory efficacy after treatment by 2 3 antiepileptic drugs; ≥ 1 time / month Cerebral palsy: all types of cerebral palsy in children less than 3 years old. - Exclusion Criteria: Febrile convulsion: family history of epilepsy, complex type of febrile convulsion, epileptic episodes, febrile convulsion plus Frequent episodes of epilepsy: combined with advanced diseases Refractory epilepsy: epilepsy combined with advanced diseases Cerebral palsy: advanced diseases combined with backwardness or retardation of brain function development.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Xingnaojing|injection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antipyretic rate , Frequency of convulsive episodes , |  | one year | 
| Frequency of convulsive episodes |  | 1 year |
Study to Determine Results of Vibratory Stimulus on Subject's Neck

Study Overview
=================
Brief Summary
-----------------
This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement.

Detailed Description
-----------------
This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement, and provide information regarding the optimum location and variable vibration parameters of vibratory stimulus on a subject's neck to cause head, neck, or jaw movement. The study will also provide information whether the subject experienced or did not experience a change in sleep stage or arousal by vibratory stimulus on a subject's neck. The data gathered from this study will be used for future studies in analyzing whether such vibratory stimulus can serve as a potential treatment for sleep disorders, such as snoring and obstructive sleep apnea.

Official Title
-----------------
Study to Determine Results of Vibratory Stimulus on Subject's Neck

Conditions
-----------------
Sleep Apnea, Snoring

Intervention / Treatment
-----------------
* Device: Kai Strap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, ages 18 to 80 years old Able to provide written informed consent for themselves and comply with study procedures. Exclusion Criteria: Known hyposensitivity or hypersensitivity to vibrations on neck. Neurological disorder such as seizure disorder or narcolepsy. Psychiatric disorders currently not under control. Insomniacs. Pregnant women.

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Kai Strap|Medical device component that vibrates on a subject's neck.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Head, neck, or jaw movement | Movement of head, neck, or jaw as evidenced by manual observation and video camera. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Affect of sleep stage | Electrocortical arousal caused by device as measured by EEG. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Apnea, Sleep apnea, Snoring, Hypoglossal nerve stimulation, Laynx stimulation
Optimal Duration of Olanzapine Add-on Therapy in Major Depression

Study Overview
=================
Brief Summary
-----------------
Evaluation of olanzapine versus placebo in the continuation therapy of subjects with major depression who had a response with additional olanzapine to an antidepressant.

Official Title
-----------------
Optimal Duration of Olanzapine Add-on Therapy in Major Depression: a Placebo-controlled, Randomized, Phase III, Pilot Study in Parallel Group Design

Conditions
-----------------
Relapse Rate of a Major Depressive Episode, Safety of Olanzapine in Subjects With Major Depression

Intervention / Treatment
-----------------
* Drug: Olanzapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent age 18 - 80 diagnosis of major depression according dsm-iv, unipolar course Hamilton-Depression-Rating-Scale (17 item score) > 18 prior to inclusion response towards therapy with antidepressant and olanzapine as defined > 50 % reduction of HAMDD score negative pregancy test highly effective contraceptive method in women no participation in other trial according to German Drug Laq normal liver function Exclusion Criteria: pregnancy, lactation depressive episode secondary to somatic disease or substance dependency contraindication for olanzapine treatment with interacting substances (CYP1A2 inhibitors or inductors) comorbidity according to DSM-IV, axis I denail of consent hospital treatment by legal order hepatic insufficiency severe neurological or medical disease adipositas permagna HIV-infection active viral hapatitis

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Olanzapine 5 mg / day | Drug: Olanzapine<br>* Olanzapine 5 mg / day for 6 months<br>* Other names: EU/1/96/022/002+019;|
| Placebo Comparator: 2<br>Placebo | Drug: Olanzapine<br>* Olanzapine 5 mg / day for 6 months<br>* Other names: EU/1/96/022/002+019;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse Rate, Hamilton Depression Rating Scale (17 item version) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major Depression, Olanzapine, add-on therapy, antidepressant, atypical antipsychotic
Effects of Pre-event Massage on Muscle Activity

Study Overview
=================
Brief Summary
-----------------
The study observes the effect of a pre-event massage on the gastrocnemius and Hamstring muscles on muscle activity.

Official Title
-----------------
Effects of Pre-event Massage on Muscle Activity During Jump Activities on Gastrocnemius and Hamstring Muscles

Conditions
-----------------
Neuromuscular Diseases

Intervention / Treatment
-----------------
* Other: Pre-event massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: Muscle injury in the last two months Suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-event massage<br> | Other: Pre-event massage<br>* Five minutes massage, combining superficial and high-frequency techniques of massage applied with the therapist hands on gastrocnemius and hamstring muscles<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle activity (microVolts) | sEMG is a NON-invasive method that measures the electrical activity of the muscle generated by the passage of the nerve impulse, which causes depolarization of the muscle cell membrane during excitation. Once the muscle is contracted and receives electrical signals, the electrodes pick up these signals and record them on the device application. | Change between baseline(immediately before intervention) and post intervention (immediately after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jump Force (Newtons) | Jump Force will be measured using the Myjump app | Change between baseline(immediately before intervention) and post intervention (immediately after intervention) | 
| Jump speed (m/s) | Jump Speed will be measured using the Myjump app | Change between baseline(immediately before intervention) and post intervention (immediately after intervention) | 
| Jump Height (cm) | Jump Height will be measured using the Myjump app | Change between baseline(immediately before intervention) and post intervention (immediately after intervention) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pre-event massage, Pre-competition massage, Gastrocnemius, Superficial Electromyography, Hamstrings
Oral Nemonoxacin in Treating Elderly Patients With CAP

Study Overview
=================
Brief Summary
-----------------
This study was to evaluate the safety and efficacy of oral nemonoxacin in treating elderly patients (aged ≥ 65 years) with community-acquired pneumonia (CAP).

Official Title
-----------------
A Multi-Center, Open-Label, Single-Arm, Phase IV Study to Evaluate the Safety and Clinical Efficacy of Oral Administration With Nemonoxacin in Treating Elderly Patients With Community-Acquired Pneumonia

Conditions
-----------------
Community-acquired Pneumonia

Intervention / Treatment
-----------------
* Drug: Nemonoxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥65 years Clinical diagnosis of CAP Evidence of inflammatory exudates or infiltrates on chest X-ray Exclusion Criteria: Suspect viral pneumonia, aspiration pneumonia, ventilator-associated pneumonia or hospital-acquired pneumonia History of hypersensitivity to quinolone or fluoroquinolone

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Nemonoxacin<br> | Drug: Nemonoxacin<br>* 500 mg, oral administration, once daily for 7-10 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after treatment with oral nemonoxacin once daily for 7-10 days |  | From Visit 1 (Baseline) till Visit 3 (within 24 hr after last dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with clinical success in the modified intention-to-treat (mITT) population, intention-to-treat (ITT), and clinically evaluable (CE) populations. |  | Visit 3 (within 24 hr after last dose) |
Psychosocial Factors and Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
To evaluate the role of psychosocial factors in the development of hypertension and cardiovascular disease.

Detailed Description
-----------------
DESIGN NARRATIVE: The studies had several interrelated themes. One was to explore the relationships between environmental stress and blood pressure over a range of time courses, with acute laboratory studies at one extreme, and long- term prospective studies at the other. The basic model of stress included three elements: the objective nature of the stressor, the individual's perception of it, and his or her physiological susceptibility. This model incorporated elements of the Karasek Job Strain model and the Frankenhaueser effort-distress model, with two components corresponding to demand and control. A third dimension was social support. These models were tested under both laboratory and field conditions. Blood pressure was the main dependent variable, together with structural changes in the heart and carotid arteries. Five projects were included. Project l evaluated the ability of ambulatory blood pressure, and blood pressure variability, to predict cardiovascular morbidity, and also included a cross-sectional study comparing the relationships between blood pressure and target organ damage in Black and white individuals. The hypothesis that white coat hypertension is a condition associated with lower risk than sustained hypertension was also tested. Project 2 prospectively evaluated the effects of job strain and social support on blood pressure and other outcome variables in a working population. Project 3 studied psychosocial and hormonal factors influencing diurnal variations of blood pressure in women, including the changes associated with menstruation and the menopause. Project 4 assessed within-subject changes of blood pressure in subjects exposed to changing levels of occupational stress over two months. Project 5 examined the conceptual models of job strain, social support, and white coat hypertension in controlled laboratory conditions. The study was renewed in FY 1998 and in FY 2003 to continue follow-up and analysis.

Official Title
-----------------
Psychosocial Factors and Cardiovascular Disease

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
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 |
| --- | --- | --- |
How Often Are Pharmacist Recommendations Followed by Emergency Physicians in Emergency Departments?

Study Overview
=================
Brief Summary
-----------------
Clinical pharmacy has played a role in Emergency Departments (ED). The presence of pharmacists have been shown to reduce medication errors and improve the medication history taken at admission. In Denmark a recent study revealed that clinical pharmacists identified medication problems in 25% of all admission to the ED, of which 47 % were considered to be serious. However, the pharmacist recommendations are of little value if they are not acknowledged or followed by the physicians. The aim of the present study was to analyze how often and under which circumstances the physicians made use of pharmaceutical recommendations in an ED with a mixed patient population with special attention to those recommendations, which were of significant or disastrous importance.

Conditions
-----------------
Pharmacist Recommendations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - all acute admissions to emergency department who were treated with one or more drugs Exclusion Criteria: - children less than 15 years.

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |
| number of pharmacist recommendations |  | up to 48 hours after admission |
Functional Outcome Following Surgical Treatment of Patients With Sternoclavicular Joint Infection

Study Overview
=================
Brief Summary
-----------------
The Sternoclavicular joints (SCJ) represents an important factor in stability of shoulder joint. Its influence and its function is important for the functionality of the shoulder. SCJ infection is a rare condition and remains often mistreated and potentially life threatening. This study is to assess the cases treated at the University Hospital Basel with a surgical approach of extended resection of the SCJ. One prospective follow-up visit inclusive one physical examination per patient will be performed to evaluate the long-term functional results of arm, shoulder, hand function with the QuickDASH questionnaire.

Official Title
-----------------
Functional Outcome Following Surgical Treatment of Patients With Sternoclavicular Joint Infection

Conditions
-----------------
Sternoclavicular Joint Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient assigned and treated at the Department of Thoracic Surgery, University Hospital Basel (USB) At hospital admission diagnosed with clinical characteristics of sternoclavicular joint infection Surgical treatment of extended SCJ resection received Signed written informed consent according to ICH-GCP regulations prior to initiation of any protocol-specific activities/procedure Patients who died will be included if a signed USB general research consent is available Exclusion Criteria: Isolated sternal or clavicular infection Patients received other surgery than extended SCJ resection at USB thoracic surgery Inability to follow procedures or insufficient knowledge of language (German/French) or inability to give consent Patients who have clearly stated that they would not agree in providing their clinical data for scientific purposes

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 |
| --- | --- | --- |
| QuickDASH score | QuickDASH score of the mobility of the arm, shoulder, hand and its function by using the QuickDASH questionnaire. The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (4 items, scored 1-5). A higher score indicates greater disability. | one time assessment at the prospective follow-up visit (timeframe of maximal 1 hour) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
QuickDASH questionnaire, extended SCJ resection
A Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug Delivery System (L-PPDS)

Study Overview
=================
Brief Summary
-----------------
The study objective is to compare IOP and safety outcomes based on plug placement (upper or lower puncta).

Official Title
-----------------
An Open-Label, Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Latanoprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension Exclusion Criteria: Uncontrolled medical conditions Subjects who wear contact lenses Subjects requiring chronic topical artificial tears, lubricants, and /or requiring any other chronic topical medications

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plug placement<br> | Drug: Latanoprost<br>* Comparison of punctal plug placement between upper and lower puncta<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure change from baseline (mmHg) |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma