linjc16/ctgov huggingface dataset:
Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.

Official Title
-----------------
An Extension to a 12-month, Open-label, Randomised, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Cyclosporine in Combination With Everolimus, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: cyclosporine (reduced exposure) / everolimus
* Drug: AEB071 300 mg b.i.d. / everolimus
* Drug: AEB071 200 mg b.i.d. / everolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient has been maintained on study drug for 12 months in the core study Exclusion criteria: Not applicable Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: cyclosporine (reduced exposure) / everolimus<br> | Drug: cyclosporine (reduced exposure) / everolimus<br>* twice daily<br>|
| Experimental: AEB071 300 mg b.i.d. / everolimus<br> | Drug: AEB071 300 mg b.i.d. / everolimus<br>* twice daily<br>|
| Experimental: AEB071 200 mg b.i.d. / everolimus<br> | Drug: AEB071 200 mg b.i.d. / everolimus<br>* twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function as measured by the glomerular filtration rate (GFR) using the modification of diet in renal disease (MDRD) formula |  | at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection, graft loss, death or loss to follow-up |  | at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney transplant, AEB071
Telomeres and Reproduction in Women

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to describe the relationship between leukocyte, granulose cell and polar body telomere length, telomere injury foci (TIFs), polarized light microscopy of oocyte spindles and their frequency in the eggs from older women and associations with aneuploidy.

Detailed Description
-----------------
The chances of conception decrease and miscarriage increase with a women's age, and the locus of reproductive aging is the egg (1). Egg dysfunction affects most women beginning by their late '30's and for many women age related egg dysfunction represents a major cause of infertility. The cause of age related egg dysfunction is poorly understood, but telomere dysfunction may play an important role. Our group has demonstrated that genetic or pharmacologic shortening of telomeres in the eggs of mice, which normally do not exhibit age related egg dysfunction, mimics reproductive aging in women, with cell cycle arrest, apoptosis, spindle dysmorphologies and chromosomal abnormalities (1,2). Moreover, a pilot study the investigators conducted five years ago suggested that telomere length of spare human eggs may predict the outcome of womens' InVitro Fertilization (IVF) cycles (3). Subsequently, other investigators have demonstrated that telomere length of circulating leukocytes predicts miscarriages (4).

Official Title
-----------------
Telomeres and Reproduction in Women

Conditions
-----------------
InVitro Fertilization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 to 48 Undergoing InVitro Fertilization Willing to donate spare eggs, granulosa cells and blood Willing to give written informed consent Exclusion Criteria: Not undergoing InVitro Fertilization Not willing to donate spare eggs, granulosa cells or blood Not willing to give written informed consent Previously donated spare eggs, granulosa cells or blood for this research project

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

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 |
| --- | --- |
| Oocyte collection<br>This is an observational study; there are no cohorts or groups | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telomere length | Describe the relationship between leukocyte, granulose cell and polar body telomere length, telomere injury foci (TIFs), polarized light microscopy of oocyte spindles | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of telomeres | The Primary outcome frequencies in the eggs from older women and associations with aneuploidy. | 1 year |
Predictors of Exposure Success in Public Speaking Anxiety

Study Overview
=================
Brief Summary
-----------------
Anxiety disorders are common and impairing. Although exposure therapy is one of the most effective treatments for anxiety, some individuals do not fully respond to treatment, and these individual differences are not well understood. Exposure therapy involves repeated, deliberate, safe engagement with a feared stimulus without the feared outcome occurring. This treatment is thought to work through a type of emotional learning called fear extinction. This study aims to look at links between fear extinction learning and exposure success, with the overall goal of better understanding who is likely to respond best to exposure therapy and why.

Official Title
-----------------
Predictors of Exposure Success in Public Speaking Anxiety

Conditions
-----------------
Performance Anxiety

Intervention / Treatment
-----------------
* Behavioral: Massed speech exposure session


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Score of at least 20 on the PRCS Age 18-55 English fluency Exclusion Criteria: Psychotropic medication use in the past 4 weeks Past experience with exposure based therapy History of bipolar disorder, psychotic disorder, or substance dependence Current major depressive disorder of greater than moderate severity (defined as a score on the 9 item Patient Health Questionnaire of greater than 14) Clinically significant suicidal or homicidal ideation Non-removable ferrous metal Current significant neurological conditions History of loss of consciousness greater than 5 minutes duration Pregnant Claustrophobic

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Public Speaking Anxiety<br>Intervention to be administered: One speech exposure session. | Behavioral: Massed speech exposure session<br>* One session consisting of 4 speech exposures, each 5 minutes long.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak Subjective Unit of Distress (SUDS) rating from first to fourth (last) exposure | Participants will complete 4 exposures during one 90 minute session. Change in the peak ratings on the final exposure relative to the first exposure will be the outcome measure. | 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on the Liebowitz Social Anxiety Scale (LSAS) at 2 weeks |  | Baseline, week 2 | 
| Change from baseline on the Personal Report of Confidence as a Speaker (PRCS) at 2 weeks |  | Baseline, week 2 |
Sun Protection Factor Assay (SPF Assay 19008)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose.

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987517


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form) Signed and dated Informed Consent Form Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

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

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

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

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: BAY987517<br>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY987517<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z12-034)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
SMA Flow Patterns in Neonatal Transfusion

Study Overview
=================
Brief Summary
-----------------
This study aims to measure the changes induced by packed red blood cell (PRBC) transfusion in the superior mesenteric artery (SMA) flow velocity and intestinal oxygenation indices in premature neonates. These changes will be measured in relation to feeding, before and after a blood transfusion. Overall reduction of intestinal perfusion is a risk factor for necrotizing enterocolitis (NEC) - a condition with significant mortality and long term morbidity. Identifying specific patterns of flow velocity and tissue oxygenation changes will allow for planning, studying and implementing risk avoidance and minimization strategies.

Detailed Description
-----------------
Hypothesis: In preterm neonates the anticipated physiologic post-prandial increase in each SMA flow and intestinal perfusion is blunted post transfusion. This is worse in SGA infants and/or in the presence of a PDA. Questions: 1) Does PRBC transfusion alter postprandial SMA flow increases and intestinal oxygenation indices in preterm infants receiving enteral feeds? 2) Is there a difference in postprandial SMA flow and intestinal perfusion changes in recently transfused SGA infants compared to AGA infants, and in those with and without a PDA? Primary Outcome: Post-prandial SMA flows changes before and after PRBC transfusion. Secondary outcomes: Pre-post prandial changes in near-infrared spectroscopy (NIRS)-measured intestinal oxygenation parameters before and after PRBC transfusion.

Official Title
-----------------
Impact of Red Cell Transfusion on Superior Mesenteric Artery Flow Patterns and Intestinal Oxygenation in Fed Preterm Neonates (SPARTAN: Sma PAttern Related to TrAnsfusion in Neonates)

Conditions
-----------------
Necrotizing Enterocolitis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prematurity (<34 completed weeks of gestation at birth) Need for PRBC transfusion Feeding at least 30ml/kg/day at the time of transfusion Exclusion Criteria: Neonates previously diagnosed with gastrointestinal problems such as NEC, intestinal perforation or atresia. Infants receiving continuous feeds or less than 30ml/kg/day Major congenital or chromosomal abnormalities or infants unlikely to survive Skin disruption precluding application of sensors

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 6 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational Study|Ultrasound and NIRS|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-prandial SMA flows changes before and after PRBC transfusion |  | Just prior to transfusion until 48 hours post completion of transfusion |
Color and Pupil Function

Study Overview
=================
Brief Summary
-----------------
This study will examine the effects of different colors of light on pupil function and alertness.

Official Title
-----------------
Effect of Light Spectrum on Pupil Function

Conditions
-----------------
Pupil

Intervention / Treatment
-----------------
* Other: Light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-35 Good health Exclusion Criteria: Sleep disorder Extreme chronotype Smoker Abnormal color vision Ocular pathology (other than mild or moderate refractive error) Visual field defects Alcohol abuse Use of illegal drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Light<br>Randomized amount and color of light | Other: Light<br>* A brief, 1 minute exposure to light of varying color and intensity. The combination of color and intensity will be the same in all participants, but the order in which they are received is randomized.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pupil size | Change in pupil size from baseline during and following brief light exposure | Baseline and 10 minutes |
Study of the Determinants of Emergency Dialysis in Reunion Island

Study Overview
=================
Brief Summary
-----------------
Among patients followed by nephrologists, the frequency of emergency dialysis starts' and their social and clinical determinants are not well known, especially in Reunion Island. In this context, we aim to study and understand the determinants of emergency dialysis initiation. For Reunion Island, the data remain very fragmented.

Official Title
-----------------
Prevalence and Epidemiology of Extra Renal Replacement Therapy

Conditions
-----------------
Dialysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient ≥18 years Starting dialysis in a dialysis centre in Réunion Island Having expressed their non-opposition or Emergency inclusion (non-opposition collected afterwards) Exclusion Criteria: Under legal protection (safeguard of justice, guardianship) Unable to answer questionnaires

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 |
| --- | --- | --- |
| Characteristics of emergency analysis | Incidence rate of emergency dialysis | 24 hours |
ATRi Transition Rollover Study

Study Overview
=================
Brief Summary
-----------------
The main purpose of the study is to monitor the safety of participant receiving long-term treatment of M6620 as monotherapy or in combination with carboplatin and paclitaxel.

Official Title
-----------------
A Rollover Study to Provide Continued Treatment With M6620

Conditions
-----------------
Advanced Stage Solid Tumors

Intervention / Treatment
-----------------
* Drug: M6620
* Drug: Carboplatin
* Drug: Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants ongoing treatment in Vertex study VX13-970-002. Participant must be able to understand and provide written informed consent. Participant must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures. Exclusion Criteria: Participants experiencing disease progression or unacceptable toxicity at the time of transition into the this study.
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: M6620 Monotherapy or Combination Therapy<br> | Drug: M6620<br>* Participant will either receive M6620 intravenously as a monotherapy on Day 1, 8 and 15 OR as a combination therapy on Day 2 and 9 of the study.<br>Drug: Carboplatin<br>* Participant will receive carboplatin intravenous infusion as a combination therapy on Day 1 of the study.<br>Drug: Paclitaxel<br>* Participant will receive paclitaxel intravenous infusion as a combination therapy on Day 1, 8 and 15 of the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (Version 4.03) |  | Up to Day 43 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ataxia telangiectasia mutated and Rad3-related protein inhibitor (ATRi), M6620, Solid tumors
Long-term Pacemaker Arrhythmia Analysis

Study Overview
=================
Brief Summary
-----------------
Investigators seek to observe the long term patterns of arrhythmias detected by permanent pacemakers.

Official Title
-----------------
East Sussex Long-term Pacemaker Arrhythmia Analysis

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-existing dual chamber permanent pacemaker Exclusion Criteria: Nil

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 |
| --- | --- |
| Permanent pacemaker<br>Pre-existing permanent pacemakers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation burden | Proportion of monitored time in atrial fibrillation | 28 days to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation episode frequency |  | 28 days to 1 year |