linjc16/ctgov huggingface dataset:
A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia

Conditions
-----------------
Hemodialysis, Hyperphosphatemia

Intervention / Treatment
-----------------
* Drug: PA21
* Drug: Sevelamer hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age 20 or older, regardless of gender. Receiving stable maintenance hemodialysis 3 times a week. Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start. Exclusion Criteria: Patients having history of a pronounced brain / cardiovascular disorder. Patients having severe gastrointestinal disorders. Patients having severe hepatic disorders.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PA21<br> | Drug: PA21<br> <br> |
| Active Comparator: Sevelamer hydrochloride<br> | Drug: Sevelamer hydrochloride<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment | Covariate: Serum phosphorus concentrations at baseline. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) |  | 12 weeks | 
| Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) |  | 12 weeks | 
| Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, Hyperphosphatemia
DXR Stent for Vascular Healing and Thrombus Formation: OCT Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of a novel dual drug-eluting stent (DXR stent), which slowly releases both cilostazol and paclitaxel, for strut coverage, malapposition, and thrombus formation, assessed by an optical coherence tomography.

Official Title
-----------------
Evaluation of DUAL Drug-eluting Stent ( DXR Stent) for Vascular Healing and Thrombus Formation : an Optical Coherence Tomography Study

Conditions
-----------------
Coronary Artery Disease, Coronary Stent Occlusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient Age >=19 years Clinically indicated to invasive coronary angiography Patient capable and willing of giving written informed consent Angiographic coronary artery disease confined to native coronary artery >50% diameter stenosis by invasive coronary angiography reference diameter 2.5-4.0mm, lesion length ≤30 mm Exclusion Criteria: Patient Inability to provide written informed consent Serious comorbidity which may affect the trial by decision of investigators Prior CABG to target vessel Congestive heart failure with NYHA Class III or IV or left ventricular ejection fraction less than 30% Prior ST elevation myocardial infarction within 72 hours from the procedure Hemodynamic or electrical instability including shock Serious coronary artery spasm, unrelated to catheter Pregnancy or possible pregnant status Allergy to iodinated contrast agent Serum creatinine >=1.7 mg/dL or creatinine clearance <= 30 ml/min ST elevation myocardial infarction Angiographic (OCT) Left main disease Severely calcified lesion Severely tortuous, or TIMI flow grade 0 or 1 by angiography, or inappropriate for OCT procedure by investigators' decision

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| DXR stent group<br>Patients who undergo coronary intervention with DXR stent | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent strut coverage (Incidence of uncovered strut) | Coronary angiography with OCT follow up | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent malapposition | Coronary angiography with OCT follow up | 6 month | 
| Stent thrombosis | Coronary angiography with OCT follow up | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Optical Coherence Tomography, Drug-Eluting Stent
Human Urine Sample Collection for Alport Nephropathy Biomarker Studies

Study Overview
=================
Brief Summary
-----------------
This is a prospective cross-sectional, observational, single-center study of Alport patients, in which a single, first morning voided urine collection will be acquired and used to validate assays of urine biomarkers that reflect changes in glomerular protein filtration barrier function. The purpose of this study is to identify biomarkers indicative of changes in glomerular filtration function that occur during the course of proteinuric renal diseases such as Alport nephropathy.

Official Title
-----------------
Human Urine Sample Collection for Alport Nephropathy Biomarker Studies

Conditions
-----------------
Alport Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Alport syndrome diagnosis (clinical and/or histopathologic and/or genetic diagnosis, per subject's physician and/or genotyping) Physically able to provide a single first-morning urine sample of at least 30 mL Exclusion criteria: Diagnosis of chronic kidney disease Receiving chronic phosphate-lowering therapy or erythropoietin therapy Ongoing chronic hemodialysis therapy and/or renal transplant recipient Nephrotic-range proteinuria: spot urine protein-to-creatinine ratio ≥ 3 on at least 2 of the last 3 clinical assessments Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alport syndrome, proteinuria, glomerular disease, hereditary nephropathy, nephropathy
The Threshold Value of Regional Cerebral Oxygenation in Detecting Cerebral Ischemia

Study Overview
=================
Brief Summary
-----------------
Using patients receiving spinal anesthesia as a model to evaluate the treshold value of cerebral oximeter to detect the symptoms of cerebral ischemia

Detailed Description
-----------------
56 patients has been recruited for the analysis of relationship between the symptoms of cerebral ischemia and the value of cerebral oximeter. All patients were recieved spinal anesthesia for the procedure of Ceserean section.

Conditions
-----------------
Cerebral Ischemia, Regional Cerebral Oxygenation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who are going to undergo Cesarean section under spinal anesthesia Exclusion Criteria: conditons contraindicated for regional anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Lupus

Study Overview
=================
Brief Summary
-----------------
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Lupus

Detailed Description
-----------------
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Lupus. This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Lupus. Patients with Lupus will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy. For patients with more severe disease an autologous T-Cell vaccine will be utilized created from the patient's own cells obtained by apheresis.

Official Title
-----------------
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Lupus

Conditions
-----------------
Lupus

Intervention / Treatment
-----------------
* Biological: AlloRx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Lupus Understanding and willingness to sign a written informed consent document Exclusion Criteria: Active infection Active cancer Chronic multisystem organ failure Pregnancy Clinically significant Abnormalities on pre-treatment laboratory evaluation Medical condition that would (based on the opinion of the investigator) compromise patient's safety. Continued drug abuse Pre-menopausal women not using contraception Previous organ transplant Hypersensitivity to sulfur
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: Treatment Group (AlloRx)<br>Single intravenous infusion of 100 million cells | Biological: AlloRx<br>* cultured allogeneic adult umbilical cord derived mesenchymal stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse events) | Clinical monitoring of possible adverse events or complications | Four year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lupus, Lupus Arthritis, stem cell treatment
Transcranial Direct Current Stimulation Aided Rehabilitation of Gait in Subacute Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if transcranial direct current stimulation (tDCS)applied over the lower extremity motor cortex in conjunction with treadmill training is effective for improving gait in patients with subacute stroke and to evaluate the effect and predictive value of a single session of anodal tDCS.

Conditions
-----------------
Stroke, Neurorehabilitation

Intervention / Treatment
-----------------
* Device: Transcranial Direct Current Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Onset of stroke less than 14 days First ischemic stroke causing lower limb weakness (MRC score ≤4 in knee extensors) and gait impairment Exclusion Criteria: Contraindications to MRI or TMS Other neurological disorders Significant somatic or psychiatric disorders History of seizures Language or cognitive disorders prohibiting participation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anodal tDCS with treadmill training<br>Each subject will receive 4 weeks gait treadmill training at least 3 days per week in combination with anodal transcranial Direct Current Stimulation over the primary motor cortex up to 20 min | Device: Transcranial Direct Current Stimulation<br>* A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue<br>* Other names: Non.invasive brain stimulation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal gait speed using the 10-m walking test |  | Baseline and follow up immediately following the 4 weeks intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cortical excitability measures | We will measure cortical excitability using single pulse transcranial magnetic stimulation (TMS) before and after 1st stimulation session. We will compare the measurements from before stimulation to after stimulation. | Baseline | 
| Dynamometry: the maximal isometric force of muscles will be assessed by Biodex System 3 PRO dynamometer |  | Baseline and immediately following the 4 weeks intervention |
Miltefosine (Long Course) for Bolivian Mucosal Leishmaniasis

Study Overview
=================
Brief Summary
-----------------
Miltefosine (longer course) will be used to try to improve the cure rate of mucosal leishmaniasis

Detailed Description
-----------------
Miltefosine (42 days) will be used to try to improve upon the cure rate with 28 days of drug for bolivian mucosal leishmaniasisi

Official Title
-----------------
Miltefosine (42 Days) for Mucosal Leishmaniasisi

Conditions
-----------------
Leishmaniasis

Intervention / Treatment
-----------------
* Drug: miltefosine: 2.5 mg/kg/day for 42 days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mucosal leishmaniasis Exclusion Criteria: No comcomitant disease as judged by laboratory and clinical parameters

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: miltefosine: 2.5 mg/kg/day for 42 days|nan|

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

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mucosal, miltefosine
Estimation of Pulmonary Capillary Blood Volume in Pre- and Postcapillary Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the role of the non-invasive assessment of nitric oxyde (NO) diffusion capacity (DLNO) in the differential diagnosis of different forms of pulmonary hypertension (PH). DLNO alone and in combination with the measurement of carbon monoxide (CO) diffusion capacity (DLCO) may help to differentiate between pre- and postcapillary forms of pulmonary hypertension. This hypothesis is based on the fact that NO has a much higher affinity to hemoglobin as compared to CO and may therefore its decrease may more specifically identify the limiting factors between the alveolar space and the lung capillaries including left heart failure (cardiac edema). As there are no available published data yet to answer this question investigators aim to perform a small pilot study. The results of this study may allow the planning of a prospective study.

Official Title
-----------------
Non-invasive Estimation of Pulmonary Capillary Blood Volume in Pre- and Postcapillary Pulmonary Hypertension - a Pilot Study

Conditions
-----------------
Hypertension Pulmonary

Intervention / Treatment
-----------------
* Other: assessment of DLNO and DLCO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing right heart catheterization patients with clear precapillary PH (PAWP<12mmHg) or clear postcapillary PH (PAWP>18mmHg) signed informed consent Exclusion Criteria: patients unable to perform the DLCO test

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 |
| --- | --- |
| precapillary<br>patients with PH and PAWP<12mmHg | Other: assessment of DLNO and DLCO<br> <br> |
| postcapillary<br>patients with PH and PAWP>18mmHg | Other: assessment of DLNO and DLCO<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in DLNO (in mmol/min/kPa) between the two predefined groups (patients with clear precapillary PH (PAWP<12mmHg) vs. clear postcapillary PH (PAWP>18mmHg)) |  | one hour |
Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the dermal sensitization potential of azelaic acid pre-foam formulation.

Detailed Description
-----------------
In an induction phase a three times weekly exposure over three weeks will be performed, followed by a resting phase. In a following challenge phase single exposure will be performed again and potential skin reactions observed. If skin reactions occur an optional re-challenge phase may be performed.

Official Title
-----------------
A Randomized, Double-blind, Vehicle Controlled Phase 1 Dermal Safety Study to Evaluate the Sensitizing Potential of Topically Applied Azelaic Acid Pre-foam Formulation in Healthy Subjects Using a Human Repeated Insult Patch Test Design

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: azelaic acid pre foam formulation
* Drug: Vehicle pre foam formulation
* Drug: Water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers male or female subjects aged 18 - 65 years ability to understand and fulfill the study requirements Exclusion Criteria: affected skin in designated test area pregnancy or lactation not willing to comply with study requirements

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum<br>Topical application of verum (azelaic acid pre foam formulation) on the skin | Drug: azelaic acid pre foam formulation<br> <br> |
| Placebo Comparator: Vehicle<br>Topical application of vehicle formulation (same as verum but without active drug substance) on the skin | Drug: Vehicle pre foam formulation<br> <br> |
| Placebo Comparator: Negative control<br>Topical application of distilled water (negative control) on the skin | Drug: Water<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin sensitization reaction | skin reactions will be assessed, using a standardized scoring scale | day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dermal sensitization potential
Maternal and Neonatal Outcome in Severe Preeclampsia

Study Overview
=================
Brief Summary
-----------------
In normal pregnancy the spiral arteries in the placental bed are invaded by trophoblast, which becomes incorporated into the vessel wall and replaces the endothelium, muscular layer and neural tissue

Detailed Description
-----------------
Preeclampsia is considered severe if one or more of the following: Blood pressure of 160mmHg systolic or high or 110mmHg diastolic or high on two occasions at least 6 hours a part while the patient on bed rest. Proteinuria of 0.3gm. or high in 24 hours urine specimen or +1 or great on two random urine samples collected at least 4 hours apart. Oliguria of less than 500ml in 24 hours. Cerebral or visual disturbance. Pulmonary edema or cyanosis.

Official Title
-----------------
Maternal and Neonatal Outcome in Severe Preeclamptic Patients

Conditions
-----------------
Pre-Eclampsia

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasonography to assess fetus and mother


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • All women with severe preeclampsia Exclusion Criteria: • History of epilepsy. Patients with chronic hypertension. Patients with renal disease.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 42 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Ultrasonography to assess fetus and mother|to assess fetal growth and maternal outcome|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of women who will develop adverse outcome | The women with preeclampsia who will develop eclampsia or pulmonaryb edema | within 5 months |