linjc16/ctgov huggingface dataset:
Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial

Study Overview
=================
Brief Summary
-----------------
We aim to compare the augmentation of clozapine with ziprasidone or risperidone in a randomized, prospective manner.

Detailed Description
-----------------
Partial response of schizophrenic psychoses to a monotherapy with clozapine is a frequent problem of clinical psychiatry. Current problems are treatment resistant positive and/or negative symptoms, as well as side effects. Therefore, different strategies of augmentations have been applied. Based on successful experiences in case reports and results of other work groups, we aim to compare the augmentation of clozapine with ziprasidone or risperidone in a randomized, prospective manner.

Official Title
-----------------
Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Drug: ziprasidone
* Drug: risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment resistant schizophrenic or schizoaffective disorder under therapy with clozapine, Age between 18 and 70, Informed consent Exclusion Criteria: No informed consent, Intolerance with respect to ziprasidone or risperidone, Contraindications with respect to these substances, Gravidity or missing anticonceptive safety Substance dependance (excluded nicotin)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: ziprasidone|nan|
|Drug: risperidone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PANSS, SANS, HAMD, GAF, CGI, QTc |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight, EPMS, Akathisia,Prolactin, blood pressure, heart rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia,, schizoaffective disorder,, treatment resistancy, clozapine,, ziprasidone, risperidone, combination
Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The primary objective of the present multicentre, prospective, non-interventional study (NIS) is gathering knowledge on the actual use and effectiveness of Elidel® in Chinese patients with mild to moderate AD affecting sensitive skin areas in routine clinical practice.

Official Title
-----------------
Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Pimecrolimus 1% Top Cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of Chinese ethnicity Patients at least 2 years old Signed informed consent from patient and if applicable from parent(s) or legal guardian(s) in compliance with local requirements Patients with mild to moderate AD and depending on the age: Patients 2-12 years must have: - SCORAD Index < 50 Patients 13 years and older must have: Affecting sensitive skin areas (e.g. face, intertriginous sites, anogenital area) SCORAD Index < 50 and IGA in sensitive skin areas ≤ 3 Exclusion Criteria: Patients for whom Elidel® is not recommended accordingly to the Package Insert Patients with severe atopic dermatitis (SCORAD Index ≥ 50 or IGA in sensitive skin > 3) Receiving systemic glucocorticoids, antibiotics, antifungals, immunomodulators, inhibitors, antihistamines and ultraviolet radiation therapy within the last 4 weeks before inclusion; Receiving any topical AD-effective drugs within the last 2 weeks before inclusion; Pregnant and/or breastfeeding women Patients or parent(s) / legal guardian (as applicable) that are not able to fulfil study requirements according to physician's opinion Patients or parent(s) / legal guardian (as applicable) that refuse to participate to the study

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| Pimecrolimus Cream 1% - Elidel®<br>Elidel® as prescribed within routine clinical practice | Drug: Pimecrolimus 1% Top Cream<br>* Elidel® as prescribed within routine clinical practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCORAD | The primary outcome measure is the change from baseline in SCORAD INDEX. The achievable score in SCORAD INDEX range from 0 to 103. The classification of severity would be as follows mild (<25), moderate (25-50) and severe (≥50). | The study ends after the Maintenance Period of at least 3 months allowing certain flexibility to respond to the routine practice. End of Study will be approx. 6 months after the inclusion depending length of the Elidel® Treatment Period. |
The Effect of Sertindole on Sensory Gating and Cognition in Schizophrenic Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate whether the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole modulates or improves both subcortical and cortical information processing in schizophrenic patients who had not or insufficiently responded to previous antipsychotic medication. This goal shall be accomplished by investigating the effect of sertindole of both prepulse inhibition of the acoustic startle (PPI) and P50 suppression of auditory evoked potentials in schizophrenic patients. These effects shall be compared to the effect of risperidone and shall also be compared to untreated healthy controls.

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

Intervention / Treatment
-----------------
* Drug: Sertindole
* Drug: Risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenia according to DSM IV Selected and treated in respect of the SPC (20 mg Serdolect max. and population at risk will be excluded) Exclusion Criteria: DSM IV Axis I disorders other than schizophrenia: Substance-dependence (excepting nicotine-dependence and substance-abuse), recent (2 months) DSM IV diagnosis according to DIA-X of a major affective, anxiety disorder, eating-disorder. DSM IV Axis II disorders: Lifetime DSM IV diagnosis of personality disorder. ECG: QTc-interval >450 msec. Systolic blood pressure <100 mmHg Bradycardia (Hf < 50/Min) und Arrhythmias Hypokalemia or Hypomagnesemia

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Schizophrenic patients treated with sertindole | Drug: Sertindole<br>* oral 12-20 mg/day<br>|
| Active Comparator: 2<br>Schizophrenic patients treated with risperidone | Drug: Risperidone<br>* oral 2-6mg / day<br>|
| No Intervention: 3<br>Healthy controls without any treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI) |  | Before and six weeks after antipsychotic treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive performances |  | Before and six weeks after antipsychotic treatment | 
| Psychopathology (PANSS rating) |  | Before and six weeks after antipsychotic treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, PPI, P50, CANTAB, sensory gating, Schizophrenic patients according to DSM-IV
The Comparison of the Effect of Pressure-controlled Ventilation and Volume-controlled Ventilation on the Gastric Insufflations in I-gel

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether the pressure controlled ventilation can reduce gastric insufflation compared to the volume controlled ventilation in patients who were mechanically ventilated with the i-gel.

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Other: Volume-controlled ventilation
* Other: Pressure-controlled ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients aged over 20 yrs who are scheduled for surgery under general anesthesia Exclusion Criteria: upper gastrointestinal surgery, surgery of long duration more than 4 hours, anticipated difficult intubation, body mass index more than 35 kg/m2, pregnancy

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volume-controlled ventilation<br>The patient's lungs will be mechanically ventilated using the volume-controlled ventilation with tidal volume 8 ml/kg. | Other: Volume-controlled ventilation<br>* I-gel will be inserted into the patient's mouth. After confirmation of adequate ventilation with the i-gel, the patient's lungs will be mechanically ventilated using the volume-controlled mode with tidal volume 8 ml/kg during surgery.<br>|
| Experimental: Pressure-controlled ventilation<br>The patient's lungs will be mechanically ventilated using the pressure-controlled ventilation with tidal volume 8 ml/kg. | Other: Pressure-controlled ventilation<br>* I-gel will be inserted into the patient's mouth. After confirmation of adequate ventilation with the i-gel, the patient's lungs will be mechanically ventilated using the pressure-controlled mode with tidal volume 8 ml/kg during surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastric antral area | The gastric antral area will be measured using ultrasonography. | Within 5 minutes after the end of surgery |
Plasticizers and in Vitro Fertilization Outcomes

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of Plasticizer metabolites concentration on the in vitro fertilization outcomes

Detailed Description
-----------------
This study was conducted in a medical center in southern Taiwan. 80 infertile female patients, aged 30 to 40 years old with normal ovarian function, receiving IVF treatment in the infertility outpatient were enrolled in this study. The participates were divided into two groups: successful pregnancy in the IVF cycle (n = 40) and non-pregnancy in the IVF cycle (n = 40). After getting the consent of the patients, we plan to do a questionnaire survey. Additionally, environmental dust and urine were sampled and analyzed the concentration of plasticizers metabolites.The aim of this study is to investigate the effect of Plasticizer metabolites concentration on the in vitro fertilization outcomes.

Official Title
-----------------
To Investigate the Effect of Plasticizers on the Pregnancy in Vitro Fertilization Cycles

Conditions
-----------------
Fertilization in Vitro

Intervention / Treatment
-----------------
* Other: Phthalate metabolites measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile women undergoing in vitro fertilization cycles Normal ovarian reserve (AMH > 1.0 and AFC ≧ 5) Exclusion Criteria: Daily homestay time > 12 hrs Diminished ovarian reserve (AMH ≦ 1.0 or AFC<5) Oophorectomy Gynecologic cancer patients Severe male infertility

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnancy<br>Infertile women undergoing in vitro fertilization cycle got pregnancy successfully. The pregnancy persisted over 12 weeks. | Other: Phthalate metabolites measurement<br>* To measure phthalate metabolites of urine and house dust in Pregnancy and Non-pregnancy groups<br>* Other names: diethylhexyl phthalate;|
| Non-pregnancy<br>Infertile women undergoing in vitro fertilization cycle failed to reach pregnancy. | Other: Phthalate metabolites measurement<br>* To measure phthalate metabolites of urine and house dust in Pregnancy and Non-pregnancy groups<br>* Other names: diethylhexyl phthalate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phthalate of urine | Phthalate metabolites concentrations | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phthalate of environmental dust | Phthalate metabolites concentrations | through study completion, an average of 1 year |
Effect of Pelvic Floor Muscle Training in Stroke

Study Overview
=================
Brief Summary
-----------------
Aim: To evaluate the long term effect of pelvic floor muscle training in women with urinary incontinence after ischemic stroke measured by quality of life paramters.

Official Title
-----------------
Six Months Follow-Up of Pelvic Floor Muscle Training in Women With Urinary Incontinence After Stroke

Conditions
-----------------
Stroke, Urinary Incontinence

Intervention / Treatment
-----------------
* Behavioral: Pelvic Floor Muscle training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female stroke patients one month since stroke UI in close relation to the stroke normal cognitive level independent walking indoor ability > 100 m independence in toilet visit Exclusion Criteria: urinary ineffections vaginal prolabs qronical lung disease psychiatric diseases other neurological diseases do not speak Danish

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Pelvic Floor Muscle training|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life parameters (SF-36, IIQ) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physiotherapy, Stroke, Urinary Incontinence, quality of Life
Finding Consensus in Fasting Terminology

Study Overview
=================
Brief Summary
-----------------
A consensus-based decision making process on fasting terminology will be conducted using the Delphi technique. To this aim, experts around the world are invited.

Detailed Description
-----------------
The consensus-based decision making process on fasting terminology will include a maximum of five rounds of questionnaires that experts are invited to complete online using a pseudonym. Prof. Dr. med. Michalsen's department has prepared rough definitions of key terms for the questionnaire to be evaluated by the experts. These terms should serve as a starting point for the discussion. After each questionnaire round the experts' comments are reviewed by the project team and a new questionnaire with the suggested modifications from the previous round will be sent to the experts. If consensus can't be reached by round three, a live-online-discussion will be held to facilitate the further proceedings. The results are to be published in a peer-reviewed journal; individual statements will not be shared in the publication.

Official Title
-----------------
Defining Fasting: Finding Common Ground Using the Delphi Method

Conditions
-----------------
Consensus Development

Intervention / Treatment
-----------------
* Other: Consensus Decision Making


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinicians or scientists with at least 5 peer-reviewed publications on fasting or at least one peer-reviewed publication and 5 years of clinical experience with fasting Exclusion Criteria: - not more than 2 experts from one institution are allowed to participate
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Consensus Decision Making|Consensus-based decision-making process, where experts are asked to comment definitions of terms used for fasting interventions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Definitions of fasting regimens | Definitions of fasting regimen (qualitative research) with max. five survey rounds and potentially one online discussion panel | repetition of the survey until consensus is reached, max. 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
consensus, fasting, fasting terminology, therapeutic fasting, Delphi, Delphi method, decision-making, intermittent fasting, periodic fasting, prolonged fasting, religious fasting, intermittent dry fasting, caloric restriction, diet, nutrition
Plasma TMAO (Trimethylamine N-oxide) as a Predictive Marker in Coronary Disease Patients

Study Overview
=================
Brief Summary
-----------------
The primary aim of the current research project is to determine whether the TMAO concentration in the blood can serve as a prognostic indicator of myocardial infarction. The hypothesis is that in patients with recent myocardial infarction, TMAO concentration in blood is higher than in patients undergoing scheduled coronarography.

Detailed Description
-----------------
To the study will be included volunteers - patients with stable angina (SA), who were scheduled for conventional coronary angiography, and patients with acute coronary syndrome (ACS) who were admitted to the hospital with chest pain and undergoing coronography surgery. Blood samples will be taken from volunteers once - before the coronography surgery by qualified medical personnel.

Official Title
-----------------
Plasma TMAO (Trimethylamine N-oxide) as a Predictive Marker in Coronary Disease Patients

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Diagnostic Test: plasma samples collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed stable angina (SA) or acute coronary syndrome (ACS) and planned coronography Exclusion Criteria: unconscious patient
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 |
| --- | --- |
| Acute Coronary Syndrome (ACS)<br>Patients with STEMI or NSTEMI infarction, who were admitted to the hospital with chest pain. | Diagnostic Test: plasma samples collection<br>* Trimethylamine N-oxide (TMAO) concentration will be determined in plasma samples<br>|
| Stable Angina (SA)<br>Patients with stable angina who were scheduled for conventional coronary angiography. | Diagnostic Test: plasma samples collection<br>* Trimethylamine N-oxide (TMAO) concentration will be determined in plasma samples<br>|
| Control Group (CON)<br>Healthy control group responding by age and gender to examined groups. | Diagnostic Test: plasma samples collection<br>* Trimethylamine N-oxide (TMAO) concentration will be determined in plasma samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trimethylamine-N-oxidec(TMAO) blood concentration | TMAO concentration determined by the ultra-performance liquid-chromatography tandem mass spektrometry (UPLC-MS/MS). | Immediately before coronography. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trimethylamine-N-oxide