linjc16/ctgov huggingface dataset:
TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether TAB08 may be beneficial compared to placebo in patients with active Systemic Lupus Erythematosus, not adequately controlled with current concomitant treatment. Secondary purpose is to assess efficacy, safety, pharmacokinetic and pharmacodynamic parameters in this study population.

Official Title
-----------------
Study to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of TAB08 in Patients With Systemic Lupus Erythematosus, Not Adequately Controlled With Current Concomitant Therapy

Conditions
-----------------
Lupus Erythematosus, Systemic

Intervention / Treatment
-----------------
* Drug: TAB08
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of Lupus Erythematosus according to American College of Rheumatology (ACR) criteria (4 of 11) Active SLE (SLE Disease Activity Index ≥ 6) Skin or joint SLE manifestations Exclusion Criteria: Lupus-nephritis and/or central nervous system affection (neuro-lupus) Prohibited treatment Pregnant or nursing women Concomitant systemic therapy dosage modification (if any) within 4 weeks before randomization

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo to TAB08 | Other: Placebo<br> <br> |
| Experimental: TAB08 Dose 1<br> | Drug: TAB08<br>* biologic<br>|
| Experimental: TAB08 Dose 2<br> | Drug: TAB08<br>* biologic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and proportion of treatment responders per SLE Responder Index (SRI) |  | 24 weeks | 
| Adverse Events |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reportet health outcome assessed by Short Form - 36 questionnaire (SF-36) |  | 24 weeks | 
| Area and severity of SLE skin damage by Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) |  | 24 weeks |
Effects of Propofol-Induced Anaesthesia on the ST-segment of the ECG

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of propofol induced general anaesthesia on the ST-segment of the electrocardiogram. This will be realised by retrospectively analysing the ECG-recordings from adult patients undergoing any treatment at the Catheterisation Laboratory. The ST-segment and other ECG measurements from induction of anaesthesia up to 20 minutes later, will be assessed and compared to the baseline values of the respective segments acquired before injecting propofol. It is essential in this study to exclude any patients burdened with the diagnosis, suspicion or family history of Brugada syndrome.

Official Title
-----------------
Effects of Propofol-Induced Anaesthesia on the ST-segment of the ECG

Conditions
-----------------
No Specific Condition (Patients Without Brugada Syndrome)

Intervention / Treatment
-----------------
* Other: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Induction of anaesthesia with propofol Monitored anaesthesia in the CathLab of the Universitair Ziekenhuis Brussel Exclusion Criteria: Brugada Syndrome or family history of Brugada syndrome Paediatric population (age <18) Patients who did not receive propofol during the procedure Patients who presented with fever (central core temperature >38,0°C)

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 |
| --- | --- |
| non-Brugada population<br>Adult patients who underwent general anaesthesia (with propofol as induction agent) at the catheterisation laboratory of the UZ Brussel | Other: Observational study<br>* Retrospective data-analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ST-segment variations after propofol administration. | Determine ST-segment variations in mm (either augmentation or suppression) on the ECG in the 20 minute period after administration of propofol in comparison to the baseline ECG | Baseline ECG will be measured before administration of propofol. ECG will be measured in the 20 minutes following administration of propofol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional ECG-segment variations after propofol administration | Assess additional ECG-segments measurements in mm and ms from the ECGs recorded. These include Jp- (mm), QRS- (ms), T(p-e)-segments (ms) and the T(p-e)/QT ratio. | Baseline ECG will be measured before administration of propofol. ECG will be measured in the 20 minutes following administration of propofol |
Role of 3 Tesla Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) for Diagnosis Bladder Cancer Grade and Stage

Study Overview
=================
Brief Summary
-----------------
assess diagnostic performance of 3-Tesla DW-MRI in detecting and staging bladder cancer and potential role of the ADC value as a biomarker reflecting histological grade and stage.

Official Title
-----------------
Role of 3 Tesla Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) for Diagnosis Bladder Cancer Grade and Stage. Potential Role of the Apparent Diffusion Coefficient (ADC) Value

Conditions
-----------------
Bladder Cancer, Diagnoses Disease, Magnetic Resonance Imaging, Apparent Diffusion Coefficient

Intervention / Treatment
-----------------
* Diagnostic Test: Magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18 years or older Suspected by the out-patient flexible cystoscopy as Non-muscle invasive bladder cancer. Patient who will undergo radical cystectomy. Patient with history of allergy to iodinated contrast media Exclusion Criteria: Refuse to complete study requirements Patient with any of the following: Any metallic fragment or foreign body Coronary and peripheral artery stents Aortic stent graft Prosthetic heart valves and annuloplasty rings Cardiac pacemaker Implanted cardioverter-defibrillator (ICD) Retained trans venous pacemaker and defibrillator leads Cochlear, otologic, or other ear implant

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Magnetic resonance imaging|Diffusion Weighted Magnetic resonance imaging|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the diagnostic performance of 3-T DW-MRI in detecting and staging bladder cancer | comparing the radiological diagnosis with the pathological specimen results | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder cancer, Magnetic Resonance Imaging, Bladder Cancer Superficial
Measurement of Stress During Anesthesia With Pain Detector on Patients Receiving Atropine

Study Overview
=================
Brief Summary
-----------------
24 patients randomly divided into two groups, one of the groups receiving atropine in addition to the planned anaesthesia. Skin conductance parameters to be compared between the two groups.

Detailed Description
-----------------
Skin conductance (SC), in terms of numbers of skin conduction fluctuations (NSCF), amplitude and mean skin conductance level, reflect the activity in the sympathetic postganglionic cholinergic fibers which innervate the palmar and plantar sweat glands. Skin conductance, especially numbers of skin conductance fluctuations, may be a promising tool to monitor anesthesia. Atropine, an anticholinergic agent, acts as an antagonist on the muscarinic receptors of the sweat glands and inhibits their secretion in a dose-dependent way. The aim of this study was to find out to what degree SC is influenced by i.v. administration of atropine. Study hypothesis: SC is not influenced by i.v. administration of atropine.

Conditions
-----------------
Hemorrhoids, Fissure in Ano

Intervention / Treatment
-----------------
* Drug: Administration of 0,7 mg of atropine
* Device: Measurement of skin conductance with Pain detector


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in ASA-group 1-2 Operations (anal fissures, anal fistulas and haemorrhoids) lasting for less than one hour informed consent BMI <30 Exclusion Criteria: Patients using any medication known to influence the autonomous nervous system Patients with contraindications to atropine (e.i. fibrillation, glaucoma ect) BMI >30 Pregnancy

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: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Administration of 0,7 mg of atropine|nan|
|Device: Measurement of skin conductance with Pain detector|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of skin conductance fluctuations |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Galvanic skin response, Anesthesia, Atropine
Non Interventional Post Marketing Programme in Acromegaly

Study Overview
=================
Brief Summary
-----------------
The purpose of this study, is to assess the safety and local tolerability of the long-term use of Somatuline Autogel when administered by patients or their partners (Home Injection Group) and the safety and local tolerability in patients receiving their injection from a healthcare professional (HCP) (Reference Group).

Official Title
-----------------
An Observational, Multicentre, Open Label, Non Interventional Programme to Assess the Long-term Safety and Efficacy of Somatuline® Autogel® in the Treatment of Acromegaly When Administered by Patients or Their Partners (Home Injection Group) or Administered by Healthcare Professionals.

Conditions
-----------------
Acromegaly

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must give written (personally signed and dated) informed consent for their data to be included in the database for this post-marketing surveillance programme and any subsequent analysis. The patient must have been receiving treatment with Somatuline Autogel at a stable dose for at least 4 months. The patient must have a diagnosis of acromegaly. The patient must be at least 18 years of age. For patients receiving or intending to receive Somatuline Autogel by home injection: The patient must be able to store Somatuline Autogel safely in a refrigerator in their own home and either collect it from their general practitioner/pharmacy on a monthly basis, or receive the medication by a home delivery service. Exclusion Criteria: The patient is pregnant or breast-feeding, unless continued treatment with Somatuline Autogel is clearly needed (as determined by the treating clinician).

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 |
| --- | --- | --- |
| safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional |  | End of observational period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of Somatuline Autogel in both groups |  | End of observational period | 
| training requirements for patients / partners to perform home injection of Somatuline Autogel |  | End of observational period | 
| acceptability of home injections to patients, partners and healthcare professionals |  | End of observational period |
Phase II Study of High-Dose Cyclophosphamide in Patients With Refractory Pemphigus

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the response rate and 1-year event-free survival of patients with refractory pemphigus treated with high-dose cyclophosphamide.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive cyclophosphamide IV on days 1-4 and filgrastim (G-CSF) beginning on day 10 and continuing until blood counts recover. Patients are followed monthly for 6 months, every 2 months for 6 months, every 4 months for a year, and then annually thereafter.

Conditions
-----------------
Pemphigus

Intervention / Treatment
-----------------
* Drug: cyclophosphamide
* Drug: filgrastim


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Definitive diagnosis of pemphigus, including all of the following: Typical clinical lesions Histologically proven by skin or mucous membrane biopsy Pemphigus IgG autoantibodies in skin or mucous membrane by direct immunofluorescence (IF) Circulating pemphigus IgG autoantibodies in serum by indirect IF Dependence on high-dose corticosteroids Persistent disease activity despite treatment with mycophenolate mofetil or azathioprine, or inability to tolerate these drugs (for paraneoplastic pemphigus, persistent disease activity despite treatment with cyclosporine) --Prior/Concurrent Therapy-- No concurrent cytotoxic therapy --Patient Characteristics-- Performance status: Karnofsky 20-100% Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: LVEF at least 40% Pulmonary: FVC, FEV1, or DLCO at least 50% predicted Other: Not pregnant Fertile patients must use effective contraception during and for 9 months after study Not preterminal or moribund

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cyclophosphamide|nan|
|Drug: filgrastim|nan|

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
-----------------
immunologic disorders and infectious disorders, pemphigus, rare disease
Aloe Vera in Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to study the effect of aloe vera in the treatment of IBS patients in a randomized, double-blind placebo controlled study.

Detailed Description
-----------------
There is limited knowledge of the IBS pathophysiology, absence of biological markers and therefore few effective treatment options. IBS therefore contributes to difficulties in the management of the patients. Aloe vera has a long association with herbal medicine, from the Ebers Papyrus from 16th century BCE. It is alleged to be effective in treatment of wounds, to improve blood glucose levels in diabetics, and it may reduce symptoms and inflammation in patients with ulcerative colitis. Evidence of the effects of aloe vera in the treatment of IBS, is however limited and contradictory.

Official Title
-----------------
Aloe Vera Versus Placebo for Patients With Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Aloe vera effervescent tablet (AVH200)
* Dietary Supplement: Placebo control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IBS according to the Rome III criteria Adults Exclusion Criteria: other GI disorders other medical conditions were pregnancy or breast-feeding food allergy or intolerance to other than lactose ongoing intake of aloe vera products

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aloe vera effervescent tablet (AVH200)<br> | Dietary Supplement: Aloe vera effervescent tablet (AVH200)<br>* 250 mg aloe vera and 60 mg ascorbic acid, Aloe Life®<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo control<br>* 60mg Ascorbic acid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBS symptoms |  | 4 weeks |
Placental Growth and Adverse Pregnancy Outcomes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to determine if measurement of maternal serum biomarkers and evaluation of the placenta by ultrasound can improve prediction of adverse pregnancy outcomes.

Detailed Description
-----------------
The placenta is known to play a vital role in maintaining a healthy pregnancy. Placental dysfunction is believed to be a driving factor in a variety of adverse obstetric outcomes, including fetal growth restriction and preeclampsia. Advances in 3D ultrasound have allowed for measurement of placental volumes during pregnancy. It may be that quantitative assessment of early placental growth can help identify pregnancies at risk for adverse outcome. Furthermore, various novel serum analytes have been proposed as predictors of adverse outcome. The investigators seek to prospectively measure placental volume and diameter at 11-14 weeks and 18-24 weeks to determine if placental growth can predict adverse outcome. In addition, the investigators seek to investigate the relationship between placental growth and serum levels of various biomarkers to see if improved detection of adverse outcome can be achieved.

Official Title
-----------------
Placental Growth and Maternal Serum Biomarkers in the Prediction of Adverse Pregnancy Outcome

Conditions
-----------------
Hypertension Induced by Pregnancy, Pre-Eclampsia, IUGR

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All singleton gestations presenting for Sequential Screen testing at HUP patients competent to provide verbal informed consent Exclusion Criteria: Multiple gestations patients not competent to provide informed consent patients found to be too late for the Sequential Screen pregnancy losses 20 weeks gestation major fetal anomalies patient delivering outside of the UPHS
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment<br>Singleton pregnancies presenting to the Genetic Counselor for Sequential Screening prior to 14 weeks gestation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Small for gestational birth weight (SGA-dichotomous) | Neonatal weight and length are recorded at birth. This information will be retrieved from the medical record post partum. | from 11-14 weeks in pregnancy until delivery (approximately 40 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Includes a composite adverse outcome defined by any of the following: SGA, pre-eclampsia, or perinatal death. | Information about pregnancy outcomes will be retrieved from the maternal and neonatal medical record post partum. | post partum |