linjc16/ctgov huggingface dataset:
Fondaparinux Population Pharmacokinetic to Morbid Obese Patients in Post-operatory Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
After bariatric surgery , thromboembolics complications are major cause of mortality. However, in obese patients, thromboprophylaxia is a controversy. Fondaparinux' efficacy is superior to HBPM, and is a good treatment for this population. Pharmacokinetics information with Fondaparinux in this population are rare.

Detailed Description
-----------------
We proposed a bicentric study cohort of obese patients (BMI > 40 kg/m2) treated by 1 day injection of Fondaparinux 2.5 mg after bypass surgery. Anti-Xa activity of Fondaparinux will be measured 4 times during hospitalisation for each patient to realise a pharmacokinetic modelisation of Fondaparinux. Haemorrhage and thromboembolics events will be collected.

Official Title
-----------------
Fondaparinux Population Pharmacokinetic to Morbid Obese Patients in Post-operatory Bariatric Surgery

Conditions
-----------------
Morbid Obesity, Obesity, Surgery

Intervention / Treatment
-----------------
* Other: blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old requiring a bariatric surgery requiring an antithrombotics prophylaxis having a morbid obesity based on a BMI >40 kg/m2 having signed the inform consent form Exclusion Criteria: contra-indication to fondaparinux history of heparin induced thrombopenia (HIT) platelets < 100 G/l requiring an effective antithrombotic treatment

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 |
| --- | --- |
| blood sample<br>Patient with 4 blood samples to measure anti-Xa activity | Other: blood samples<br>* patients with a fondaparinux treatment who have 4 blood samples during the 10 days following surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate pharmacodynamics parameters of fondaparinux based on anti-Xa activity estimated by a non linear model at mixed effect of obese morbid patients following a bariatric surgery |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the incidence of symptomatic venous thromboembolics events (DVT and PE) between D5 and D10 and at 1month ± 10 days |  | D5 | 
| the incidence of major and clinically significative bleeding between D5 and D10 and at 1 month ± 10 days |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, fondaparinux, surgery, anti-Xa activity
Blepharospasm Patient Survey for Patients With Blepharospasm

Study Overview
=================
Brief Summary
-----------------
The purpose of this survey is to collect detailed information on patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA, including how often they are treated with botulinum toxin, how long their treatment lasts, how satisfied they are with their treatment, and if there is any improvement in their symptoms with the treatment.

Detailed Description
-----------------
This study is open to males and females > 18 years and < 81 years with a clinical diagnosis of blepharospasm.

Official Title
-----------------
Blepharospasm Patient Survey: A Structured Interview Evaluating Previous and Current incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA Treatment for Patients With Blepharospasm

Conditions
-----------------
Blepharospasm

Intervention / Treatment
-----------------
* Other: No intervention- only one time survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subject aged > 18 years and < 81 years Documented clinical diagnosis of blepharospasm Currently receiving incobotulinumtoxinA, abobotulinumtoxinA or onabotulinumtoxinA Exclusion Criteria: Previous treatment with rimabotulinumtoxinB in the last 2 treatment cycles

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 81 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 |
| --- | --- |
| Blepharospasm Survey Group<br> | Other: No intervention- only one time survey<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Botulinum Toxin Treatment Information | The following information for patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA, or onabotulinumtoxinA treatment is collected: (1) botulinum treatment information such as intervals for botulinum injections, physician's rationale for injection interval, overall experience with botulinum toxin injections (onset, maximum effect, decline of effect), current injection cycle experience (current satisfaction, satisfaction at maximum effect, and visual analog scale (VAS) of current health status); and (2) disability status using the Blepharospasm Disability Index (BSDI) and the Jankovic Rating Scale (JRS) | This is a single, structured interview about experiences with Botulinum Toxins |
Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study)

Study Overview
=================
Brief Summary
-----------------
Determine the efficacy and tolerability of olanzapine for treatment of acute depression in patients with bipolar II or bipolar disorder NOS compared with lithium.

Official Title
-----------------
A Randomized, Open Label Trial of Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified.

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: olanzapine
* Drug: lithium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: major depressive episode in type2 bipolar disorder or bipolar disorder NOS.(MADRS more than 20 point) 18years to 65years subjects who sign the informed consent document Exclusion Criteria: don't have Diabetes and abnormal metabolism of sugar not noticed as bipolar disorder have an organic brain disease pregnant or breastfeeding women don't have heart disease have actively suicidal thought(Suicidal ideation score of MADRS is 6) who are judged by the investigator to should be excluded from the study

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olanzapine<br>PO start with 2.5mg daily once for 7days, since then flexible dose. | Drug: olanzapine<br> <br> |
| Active Comparator: Lithium<br>PO start with 400mg daily twice for 7days, since then flexible dose. | Drug: lithium<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Montgomery- Åsberg Depression Rating(MADRS) |  | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Young Mania Rating Scale(YMARS) |  | Baseline and 8 weeks | 
| Quick Inventory of Depressive Symptomatology Japanese version(QIDS-J) |  | Baseline and 8 weeks | 
| State Trait Anxiety Inventory Form JYZ(STAI) |  | Baseline and 8 weeks | 
| Clinical Global Impression for Bipolar Disorder(CGI-BP) |  | Baseline and 8 weeks |
Measurement of the Skin Sympathetic Nerve Activity

Study Overview
=================
Brief Summary
-----------------
Sympathetic nerve activity can be measured transcutaneously in awake patients by computer-based filtering of raw signal obtained via skin leads attached on the chest. Electrocardiogram can be removed by applying a high-pass filter setting of 150 Hz. Electromyogram can be filtered by applying a high-pass filter setting of 500 Hz or a band-pass filter setting of 500-1000 Hz. However, it is not known whether the skin sympathetic nerve activity (SKNA) can be measured in anesthetized and/or paralyzed patients. Therefore, we planned this pilot study to observe whether the SKNA can be obtained in these patients. If the SKNA ca be observed, it will be presented in milivolt (uV).

Official Title
-----------------
Recording Sympathetic Nerve Activity From the Skin During Surgery Under General Anesthesia : a Pilot Study

Conditions
-----------------
Skin Sympathetic Nerve Activity During General Anesthesia in Patients Undergoing Breast Cancer Surgery

Intervention / Treatment
-----------------
* Drug: Rocuronium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled to undergo resection of breast cancer under general anesthesia after insertion of laryngeal mask airway Exclusion Criteria: Autonomic nervous system disease Medication acting on the autonomic nervous system Refuse to participate

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ROC<br>Neuromuscular blockade is performed in the ROC group by administering rocuronium 0.4 0.8mg/kg before the insertion of laryngeal airway. | Drug: Rocuronium<br>* whether neuromuscular blockade by administering rocuronium is performed or not.<br>|
| No Intervention: Control<br>Neuromuscular blockade is not performed. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The skin sympathetic nerve activity presented as uV obtained via skin leads. | A few studies reported that skin sympathetic nerve activity (SKNA) signal could be potentially observed by applying a high-pass filter of 500 Hz or a band-pass filter of 500 1000 Hz to electric signal from skin leads attached on the skin of the chest in awake volunteers. However, it is not known if it would be also possible to observe the SKNA signal in anesthetized patients. Also, there is no established method for quantitative or qualitative assessment of the SKNA signal. | During surgery/anesthesia |
Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the vascular effects of tibolone on climateric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.

Conditions
-----------------
Flow-mediated Dilation Evaluation of the Brachial Artery

Intervention / Treatment
-----------------
* Drug: Tibolone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women without menstrual cycles whithin the last 12 months and FSH>30IU/L Healthy women Women that were not using drugs with potential vascular effect whithin the last 1 year Women that never used hormone replacement therapy Exclusion Criteria: Smoking Blood Pressure > 160/90 mm Hg. Breast and or endometrial cancer History of acute myocardial infarction Diabetes Vaginal bleeding of any origin Hepatic disease thrombophlebitis or thromboembolic disorders

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: Tibolone<br>patientes will use tibolone 2,5mg/day during 30 days | Drug: Tibolone<br> <br> * Other names: Livial;|
| Placebo Comparator: Placebo use<br>Patients will use placebo for 30 days | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery | Flow-mediated dilation will be measured by high resolution ultrasound | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hormone replacement therapy; Dopplervelocimetry; Flow-mediated dilation; menopause; tibolone
Stereotactic Aspiration for Primary Brainstem Hemorrhage Based on 'Zhe-er Classification'

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the benefit of stereotaxic aspiration for patients with primary brainstem hemorrhage with the guidance of 'Zhe-er Classification'

Detailed Description
-----------------
This is a retrospective study aiming to analyze the clinical record of patients from March 2014 to October 2020. This study is indicated for primary brainstem hemorrhage.

Official Title
-----------------
A Descriptive Research on the Effect of Primary Brainstem Hemorrhage Stereotactic Aspiration Based on 'Zhe-er Classification'

Conditions
-----------------
Primary Brainstem Hemorrhage

Intervention / Treatment
-----------------
* Other: No interventions - retrospective data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
no new patients will be enrolled within this project Inclusion Criteria: Patients undergoing a stereotaxic aspiration or conservative therapy from 3/2014 to 10/2020 in 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Exclusion Criteria: patients with secondary brainstem hemorrhage due to blood vessel malformation, trauma, or malignancies
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients received stereotaxic aspiration<br>No new/additional patients will be enrolled within this project. Only retrospective data will be collected on survival time and life quality | Other: No interventions - retrospective data collection<br>* No new/additional patients will be enrolled within this project.<br>|
| Patients received conservative therapy<br>No new/additional patients will be enrolled within this project. Only retrospective data will be collected on survival time and life quality | Other: No interventions - retrospective data collection<br>* No new/additional patients will be enrolled within this project.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival events | Survival events include death, deterioration/recovery of nervous function | 1 year after hemorrhage |
A Study on the Effect of Food on the Pharmacokinetics of RO5428029 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This open label, two period, crossover study will evaluate the safety and the effect of food on the pharmacokinetics of RO5428029 in healthy volunteers. In a crossover design, healthy subjects will be randomized to receive a single oral dose of RO5428029 with or without food, with a washout period of at least 7 days between dosing and a follow-up of 7 to 10 days after last dose. Anticipated time on study will be up to 21 days.

Official Title
-----------------
A Randomized, Open Label, Single Dose, Two Period, Crossover Study to Assess the Effect of Food on the Pharmacokinetics of RO5428029 Following Oral Administration in Healthy Subjects

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: RO5428029


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers, 18 to 60 years of age inclusive Body mass index (BMI) between 18 and 29.9 kg/m2, inclusive, and a minimum weight of 45 kg Female subjects must be surgically sterile or post-menopausal Male subjects and their partners of child-bearing potential must use 2 methods of contraception (one of which a barrier method) for the duration of the study and for at least 70 days after the last dose Exclusion Criteria: Pregnant or lactating women, and male partners of women who are pregnant or lactating Women with reproductive potential History (within 3 months of screening) of alcohol consumption exceeding 2 standard units per day on average; alcohol consumption will be prohibited at least 48 hours before screening Positive test for drugs of abuse History or symptoms of any significant disease Positive for HIV, hepatitis B or hepatitis C infection Participation in an investigational drug or device study within 3 months prior to screening

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A food<br> | Drug: RO5428029<br>* Single oral dose<br>|
| Experimental: B without food<br> | Drug: RO5428029<br>* Single oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of food on pharmacokinetics (plasma concentrations) of RO5428029 following oral administration |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | approximately 3 weeks |
Risk Factors for Failure After Single-incision Sling Procedure in Women With Stress Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
The main risk factors for failure after single-incision slings are reduced urethral mobility and stress urinary incontinence severity in long-term follow-up.

Detailed Description
-----------------
The medical records of the 132 patients were retrospectively analyzed. Preoperative assessment included medical history and urogynecological examination. Patients were asked to answer validated questionnaires such as Urinary Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7). Objective cure of SUI was defined as the absence of demonstrable leakage of urine on the cough stress test. Subjective cure was based on negative response to UDI-6, question 3. Patients were divided according to objective cure rate into two groups: cured (Group A) and failed patients (Group B).

Official Title
-----------------
Risk Factors for Failure After Single-incision Sling Procedure. Retrospective Analysis of 132 Women

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Procedure: Single-Incision Sling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who underwent single-incision sling procedure for stress urinary incontinence Exclusion Criteria: Urodinamically proven detrusor overactivity Neurogenic bladder Previous anti-incontinence surgery including midurethral slings Postvoidal residual volume (PVR) >100mL Previous radical pelvic surgery Anterior pelvic organ prolapse greater than stage I

Ages Eligible for Study
-----------------
Minimum Age: 37 Years
Maximum Age: 78 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Single-Incision Sling|The women with stress urinary incontinence underwent single-incision sling procedure.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective cure | negative cough stress test | September 2009 to September 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective cure | negative response to Urinary Distress Inventory (UDI-6), question 3. | September 2009 to September 2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Single-Incision Sling, Stress Urinary Incontinence, Failure
Metabolic Changes Induced by Genetically Modified Potatoes

Study Overview
=================
Brief Summary
-----------------
Starches from genetically modified potatoes, which differed in terms of amylose, amylopectin and phosphate content, were tested in a human randomized controlled trial.

Conditions
-----------------
Glucose Metabolism, Endocrine Metabolism, Satiety

Intervention / Treatment
-----------------
* Other: Genetically modified potatoes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy males Exclusion Criteria: no acute oder severe chronic diseases

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Starch 1<br>Starch 1 | Other: Genetically modified potatoes<br>* Starch from genetically modified potatoes<br>|
| Other: Starch 2<br>Starch 2 | Other: Genetically modified potatoes<br>* Starch from genetically modified potatoes<br>|
| Other: Starch 3<br>Starch 3 | Other: Genetically modified potatoes<br>* Starch from genetically modified potatoes<br>|
| Other: Starch 4<br>Starch 4 | Other: Genetically modified potatoes<br>* Starch from genetically modified potatoes<br>|
| Other: Starch 5<br>Starch 5 | Other: Genetically modified potatoes<br>* Starch from genetically modified potatoes<br>|
| Other: Starch 6<br>Starch 6 | Other: Genetically modified potatoes<br>* Starch from genetically modified potatoes<br>|
| Other: Starch 7<br>Starch 7 | Other: Genetically modified potatoes<br>* Starch from genetically modified potatoes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose metabolism |  | 2 days |