linjc16/ctgov huggingface dataset:
Alport Syndrome Treatments and Outcomes Registry

Study Overview
=================
Brief Summary
-----------------
ASTOR's primary purpose is to enroll families and patients with a history of Alport syndrome in a central registry. The information we gather will be used as a basis for studies designed to test potential treatments for Alport syndrome. ASTOR also aims to provide patients, families and physicians with the most up-to-date information about Alport syndrome.

Detailed Description
-----------------
The University of Minnesota's Department of Pediatrics has created the Alport Syndrome Treatments and Outcomes Registry (ASTOR). ASTOR's primary purpose is to enroll families and patients with a history of Alport syndrome in a central registry. The information we gather will be used as a basis for studies designed to test potential treatments for Alport syndrome. ASTOR also aims to provide patients, families and physicians with the most up-to-date information about Alport syndrome. You can help doctors learn more about Alport syndrome and test possible treatments for the disease by enrolling in ASTOR. Since Alport syndrome is a rare disease it is essential for ASTOR to enroll as many patients as possible. Together, you and others facing the challenges of Alport syndrome can provide valuable information that will help doctors better understand the disease and in turn, help patients with Alport syndrome now and in the future.

Official Title
-----------------
Alport Syndrome Treatments and Outcomes Registry

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

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: History of a diagnosis of Alport syndrome, Family or individuals need to be able to comprehend the consent and HIPAA forms written in the English language. Exclusion Criteria: Uncertain diagnosis of Alport syndrome.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Data Collection: natural history study |  | Ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alport Syndrome, x linked, autosomal dominant Alport syndrome, glomerular basement membrane, hereditary nephritis, familial benign haematuria, type IV collagen, hereditary nephritis with neurosensory deafness, vison loss
Reliability and Validity of HHIRS General Quality of Life Questionnaire

Study Overview
=================
Brief Summary
-----------------
Quality of life is conceded by copious musculoskeletal and neurogenic conditions which are evaluated by manifold questionnaires. These questionnaires are obtainable in English and many other languages but in Pakistan, these cannot be applied due to differences in languages, lifestyles, culture, and activities of daily living (ADL's). In relation to the culture of Pakistan, there are many accomplishments such as offer prayers and other domestic obligation which cannot be executed appropriately if any Musculoskeletal and neurogenic disorders are existing. All these disorders can be assessed appropriately by questionnaires previously accessible but not in a single tool.

Detailed Description
-----------------
HHIRS developed a general quality of life questionnaire in the Urdu language for the expediency of patients. Relation of the questionnaire with upper limb has been identified but there is no clear relation with other body regions. Consequently, the purpose of this research is to evaluate the validity and reliability of the HHIRS-General-QOL Questionnaire in the Urdu Speaking Population of Pakistan.

Official Title
-----------------
Reliability and Validity of HHIRS General Quality of Life Questionnaire in Urdu Speaking Population of Pakistan

Conditions
-----------------
Musculoskeletal Pain, Neurological Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participants able to read and write Urdu neurological disorders musculoskeletal pain systemic diseases Exclusion Criteria: communication disorder cognitive disorder

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| validity of HHIRS general quality of life questionnaire | validity of questionnaire will be determined by comparing the responses of patients for HHIRS-GQOL questionnaire with GHQ-12 questionnaire | 2 months | 
| Reliability of HHIRS general quality of life questionnaire | reliability will be measured by comparing the score the score of questionnaires collected at two different occasions | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reliability, Validity, HHIRS-General-QOL, questionnaire, patient reported outcome measure
ACT-MBC: A Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer (MBC)

Study Overview
=================
Brief Summary
-----------------
ACT-MBC prospectively assesses the impact of CTCs on treatment decisions, response assessment and prognosis in MBC patients.

Official Title
-----------------
ACT-MBC: A Prospective Observational Impact Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: CellSearch Circulating Tumor Cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease ER+/HER2- patients prior to starting 2nd line therapy or beyond OR ER/Progesterone Receptor (PR)/HER2-negative (Triple Negative) patients prior to starting any line of therapy Measurable and/or non-measurable disease is allowed Male or female breast cancer is allowed Age > 18 years Willingness to provide mandatory blood specimens Willing to return to enrolling institution for follow up imaging at least once Exclusion Criteria: Life expectancy of ≤ 6 months Inability to provide blood samples based on the judgment of the treating provider

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: CellSearch Circulating Tumor Cells|Serial CTC enumeration|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To prospectively evaluate the impact of CellSearch CTCs on treatment decisions and response assessment in MBC patients | Assessing proportion of providers that find CellSearch CTCs helpful in determining response to therapy in each unique patient (Questionnaire #2). | 3 to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess barriers and receptiveness of providers in using CTCs in clinical practice | Assessing provider perception of the general usefulness of CTC in pre and post-intervention surveys (Questionnaire #1 and #3) | 18 months | 
| Evaluate if CTC results correlate with response assessment and disease progression defined by standard of care imaging | Compare baseline and on treatment serial CTCs assessment to identify correlations with first restaging studies and with progression free survival | 18 months |
AWARE - Chronic Urticaria

Study Overview
=================
Brief Summary
-----------------
Non interventional study collecting patient reported outcomes. The study aims to assess the disease burden of chronic urticaria patients and to record the therapies used in daily clinical practice in the UK and the impact they have on the quality of life and work productivity of individual patients.

Official Title
-----------------
AWARE: A World-wide Antihistamine-Refractory Chronic Urticaria Patient Evaluation

Conditions
-----------------
Chronic Urticaria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be 18 years old Subject must be willing and able to provide written informed consent for collection and analysis of routine data and PROs Subject must have medically confirmed diagnosis of chronic urticaria present for more than 2 months. Subject must be refactory to at least one H1 antihistamine Exclusion Criteria: Subjects who in the estimation of the treating physician are unlikely to be available for the full duration of the follow-up period of 24 months. Subjects taking must not take part in any other concurrent urticarial study. -

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 |
| --- | --- | --- |
| Measuring responses to PROs from patients on different treatments | Measuring quality of life, work productivity and changes in disease for patients on different treatment. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To record use of clinical resources | Measuring how often clinical resources (hospitalisations, frequency of visits) are used | 24 months | 
| Previous, current and future medication | Recording medication use throughout the 24 months | 24 months | 
| The disease burden of chronic urticaria | The disease burden (including impact on sleep and work productivity) | 24 months | 
| Rates of spontaneous remission |  | 24 months | 
| Treatment algorithms and trends | Measuring treatment algorithms and trends during the study course (including therapy adjustments and duration of use of each substance class) | 24 months | 
| Co-morbidities of refractory CU patients |  | 24 months | 
| first onset of chronic urticaria | Time of first onset of the disease and number physicians consulted | 24 months | 
| Number of patients with angiodema |  | 24 months | 
| Number of angioedema episodes during the observational phase |  | 24 months | 
| Prevalence of inducible urticaria | The number of patients in the study population that are diagnosed with inducible urticaria. | 24 months | 
| Diagnosis of CSU |  | 24 months |
Drug Eluting Pantera Lux Catheter Registry

Study Overview
=================
Brief Summary
-----------------
All comers registry - Evaluation of the safety and efficacy of the Pantera Lux Paclitaxel releasing balloon for coronary arteries in daily clinical practice.

Detailed Description
-----------------
All patients are treated with the Pantera Lux Paclitaxel releasing balloon. Clinical follow ups at 1, 6 and 12 months after coronary intervention.

Official Title
-----------------
Evaluation of the Safety Profile of the Pantera Lux Paclitaxel Releasing Balloon for Coronary Arteries in Daily Clinical Practice

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Signed Patient Informed Consent / Data Release Form Patient eligible for percutaneous coronary intervention (PCI) Patient is older than 18 years of age Exclusion Criteria Patient has a known allergy against appropriate anticoagulation / antiplatelet therapy Patients with known allergy against paclitaxel or BTHC Patients with a target lesion that was previously treated by brachytherapy Pregnant woman or lactating woman

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 |
| --- | --- | --- |
| Major Adverse Cardiac Events (MACE) | Death, non-fatal MI, clinically driven target vessel revascularization (TVR) | 6 M | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | Death, non-fatal MI, clinically driven TVR | 12 M | 
| All MACE | Death, non-fatal MI, any revascularization | 1, 6, and12 M | 
| Clinically driven TVR |  | 1, 6 and 12 M | 
| Acute success | Clinical device success, clinical procedure success | Post procedure |
AT278 and NovoRapid® in Glucose Clamp Study

Study Overview
=================
Brief Summary
-----------------
A phase 1, randomised, single-centre, double-blind, single-dose, two period balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT278 and NovoRapid® in male participants with type 1 diabetes.

Official Title
-----------------
Phase 1 Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics and Safety of Arecor Rapid-acting Concentrated Insulin Aspart (AT278) in Comparison to Insulin Aspart NovoRapid® in Participants With Type 1 Diabetes Mellitus (T1DM).

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: AT278
* Drug: NovoRapid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of type 1 diabetes for at least 12 months Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months HbA1c concentration ≤8.5% at screening Weight within the range 75kg - 100kg (both inclusive) Exclusion Criteria: Known or suspected hypersensitivity to Investigational Medicinal Products Clinically significant concomitant disease or abnormal lab values Supine systolic BP outside range 95-140mmHg and/or diastolic BP greater than 90mmHG

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AT278<br>Single subcutaneous injection 0.3U/kg | Drug: AT278<br>* Concentrated rapid acting insulin aspart<br>Drug: NovoRapid<br>* Rapid acting insulin aspart<br>* Other names: NovoLog;|
| Active Comparator: NovoRapid<br>Single subcutaneous injection 0.3U/kg | Drug: AT278<br>* Concentrated rapid acting insulin aspart<br>Drug: NovoRapid<br>* Rapid acting insulin aspart<br>* Other names: NovoLog;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion-rate curve of insulin aspart |  | 0 - 8 hours |
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children

Study Overview
=================
Brief Summary
-----------------
The study will collect cerebral oximetry data from pediatric and neonatal subjects using the Masimo O3 regional oximetry device, for the purposes of device calibration and validation.

Official Title
-----------------
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children Undergoing Cardiac Catherization

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Device: O3 regional oximeter sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients undergoing cardiac catheterization procedure for treatment or diagnosis of cardiovascular disease 1 day to less than 18 years of age Weight between 3.5 and 40 kg Parental or legal guardian consent and subject assent Exclusion Criteria: Failure to obtain written consent Equal or more than 18 years in age Weight more than 40kg or less than 3.5kg Jaundice with bilirubin levels higher than the reference range Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent motioning of SpO2 levels during the study or placement of cerebral oximeter

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum 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: Test group<br>All subjects are enrolled in the test group and receive an O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure. | Device: O3 regional oximeter sensor<br>* Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Sensor by Arms Calculation of Percent rSO2 | The continuous measurements of regional oxygen saturation (rSO2) was compared against its reference cerebral oxygen saturation which is measured by a combination of arterial and jugular venous blood oxygen saturation. Absolute accuracy was determined by the root-mean-squared error (Arms). The Arms error value is calculated as the square root of the sum of the squares of mean bias and estimated standard deviation of bias. The bias is defined as the difference of the rSO2 and its blood reference. | One visit; up to 4 hours |
OxyPrem Validation Study

Study Overview
=================
Brief Summary
-----------------
The precision of the novel diagnostic near-infrared spectroscopy (NIRS) device for the measurement of tissue oxygenation and hemoglobin concentration (OxyPrem) is assessed by repeated measurements. The accuracy of OxyPrem is assessed by comparing the measurement data to those acquired simultaneously by established NIRS devices and standard clinical monitoring devices. In substudy 1, healthy adult subjects are enrolled, in substudy 2, measurements are conducted on preterm neonates.

Official Title
-----------------
A Miniaturized Device to Non-invasively Measure the Oxygenation and Hemoglobin Concentration in the Brain Using Near-infrared Spectroscopy

Conditions
-----------------
Tissue Oxygenation Measurement

Intervention / Treatment
-----------------
* Device: Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels)


Participation Criteria
=================
Eligibility Criteria
-----------------
Substudy 1 (healthy adult volunteers) Inclusion Criteria: Healthy adult Signed informed consent Exclusion Criteria: Dense black hair at the location of measurement Neurological diseases. Substudy 2 (preterm infants) Inclusion Criteria: Pre-term neonates (gestational age at birth less than 37 weeks) Signed informed consent by at least one parent Exclusion Criteria: Clinically instability Malformations
Sexes Eligible for Study
-----------------
All

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

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: precision and accuracy study<br>precision and accuracy of Oxyprem are studied | Device: Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels)<br>* The precision of OxyPrem is assessed by repeated measurements of tissue oxygenation and hemoglobin concentration. The accuracy of OxyPrem is assessed by comparing the measurement data to those acquired simultaneously by established NIRS devices and standard clinical monitoring devices. In substudy 1, healthy adult subjects are enrolled, in substudy 2, measurements are conducted on preterm neonates.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard deviation of repeated StO2 level measurements (precision) | The precision of the StO2 measurement is the reproducibility within multiple consecutive measurements under similar conditions, expressed as the standard deviation of repeated measurements. | baseline |
Icare Versus Haag-Streit Applanation Tonometer

Study Overview
=================
Brief Summary
-----------------
The clinical performance of Icare ONE Tonometer TA02 was compared to a Goldmann type applanation tonometer (Haag-Streit). Data was collected according to ANSI Z80.10-2003 (ISO 8612.2) standard. Subjects were eligible for the study if they had no exclusion criteria specified in the ANSI/ISO standard. One eye from 260 subjects was selected for the study. The minimum sample size according to the standard is 150. One eye of each subject was selected for the study by an investigator, based on the history of the patient, results of an external examination of the eye with slit lamp, keratometry readings, and prior knowledge of the intraocular pressure (IOP) range. The Icare ONE Tonometer TA02 in comparison to the reference tonometer (Goldmann type tonometer).

Official Title
-----------------
Design Compliance Testing of the Icare One Rebound Tonometer According to the American National Standard ANSI Z80.10-2001 and International Standard ISO 8612.2 for Tonometers

Conditions
-----------------
Intraocular Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects were eligible for the study if they had no exclusion criteria as specified by the ANSI/ISO standard Subjects were selected according to the following exclusion criteria (as given in ANSI Z80.10-2003 and ISO 8612): subjects with only one functional eye those with one eye having poor or eccentric fixation high corneal astigmatism (i.e. those eyes displaying an oval contact image with the Goldmann tonometer) those with corneal scarring or who have had corneal surgery, including corneal laser surgery microphthalmos buphthalmos contact lens wearers dry eyes lid squeezers (blepharospasm) nystagmus keratoconus any other corneal or conjunctival pathology or infection

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

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

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

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

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