linjc16/ctgov huggingface dataset:
A Study of LY3041658 in Participants With Skin Diseases

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to investigate the safety and tolerability of the study drug known as LY3041658 in participants with certain types of skin diseases. The study will measure how the body absorbs, breaks down and gets rid of LY3041658. It will last about 127 days for each participant, not including screening. This study is for research purposes only, and is not intended to treat any medical condition.

Official Title
-----------------
A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3041658 in Patients With Skin Diseases

Conditions
-----------------
Skin Diseases, Psoriasis

Intervention / Treatment
-----------------
* Drug: LY3041658
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Investigator confirmed diagnosis of certain skin diseases for at least 6 months. Active skin lesions that are not responding to standard therapies. Willing to undergo pre- and post-treatment skin biopsies of lesions. Exclusion Criteria: - Have other skin diseases that may interfere with evaluation of the specified skin disease being studied.

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: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3041658<br>LY3041658 administered intravenously (IV) once every two weeks over 6 weeks (four doses). | Drug: LY3041658<br>* Administered IV.<br>|
| Placebo Comparator: Placebo<br>Placebo administered IV once every two weeks over 6 weeks (four doses). | Drug: Placebo<br>* Administered IV.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |  | Dosing Day 1 through Day 127 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658 |  | Dosing Day 1 through Day 127 | 
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) During Dosing Interval at Steady State (AUCss) of LY3041658 |  | Dosing Day 1 through Day 127 | 
| Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3041658 |  | Dosing Day 1 through Day 127 |
The Impact of Storage Techniques on Platelets Number and Function After Acute Normovolemic Hemodilution (ANH)

Study Overview
=================
Brief Summary
-----------------
Acute normovolemic hemodilution (ANH) is part of our current protocol to decrease post-operative bleeding and homologous blood transfusions post cardiopulmonary bypass. Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine. In our practice we noticed some variability in the impact of ANH on postoperative bleeding; with some patients appearing to show more hemostasis after separation from CPB than others. This is a prospective study to find out if there is an optimal time period that guarantees the largest amount of functioning platelets and what is the best practice for drawing and storing of ANH to guarantee the largest amount of functioning platelets.

Conditions
-----------------
Cardiac Surgical Procedures

Intervention / Treatment
-----------------
* Procedure: Acute normovolemic hemodilution (ANH)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing cardiac surgery on CPB and are determined to be suitable for ANH by the cardiac team during the huddle process per our standard protocol. Exclusion Criteria: Patients who are undergoing cardiac surgery on CPB who are determined not to be suitable candidates for ANH by the cardiac team during the huddle process per our standard protocol.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute normovolemic hemodilution (ANH)<br>Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery. | Procedure: Acute normovolemic hemodilution (ANH)<br>* Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Platelet Aggregation as Measured Using Collagen-epinephrine (EPI) | The membrane of the cartridges are coated with collagen and epinephrine (EPI) inducing a platelet plug to form which closes the aperture. | Just prior to re-transfusion, assessed up to 5 minutes | 
| Time to Platelet Aggregation as Measured Using Collagen-Adenosine (ADP) | The membrane of the cartridges are coated with collagen and adenosine diphosphate (ADP) inducing a platelet plug to form which closes the aperture. | Just prior to re-transfusion, assessed up to 5 minutes |
Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to study the efficacy (as measured by change in FEV1) and safety of two-week administration of oral QAV680 in the treatment of patients with asthma.'

Official Title
-----------------
Randomized, Double-blind, Two Way Cross-over, Proof of Concept Study to Compare Efficacy, Safety, Pharmacokinetics & Pharmacodynamics of QAV680 Versus Placebo, With an Extended Open-label Corticosteroid Period, in Steroid-free, Mild to Moderate Persistent Asthma Patients.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: QAV680
* Drug: Matching placebo for QAV680
* Drug: Fluticasone Propionate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Mild to moderate persistent asthma for at least 6 months. Exclusion criteria: Past or recent history of significant medical illness and/or lab abnormalities including but not limited to ECG abnormalities, abnormal LFT, HIV, Hep B/C, Allergic disorders, pancreatic disease, serious underlying respiratory diseases, life threatening asthma, renal disease etc Surgical and/or medical conditions which significantly effect ADME of the drug. Prior use of asthma medications (except SABA's) prior to 2 weeks of dosing Other protocol-defined inclusion/exclusion criteria may apply

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QAV680<br> | Drug: QAV680<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Matching placebo for QAV680<br> <br> |
| Active Comparator: Fluticasone Propionate Inhaler<br> | Drug: Fluticasone Propionate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry. |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Change in Asthma Control Questionnaire (ACQ) score |  | 2 weeks | 
| Measure: Frequency of salbutamol usage |  | 2 weeks | 
| Measure: Change in exhaled Nitric Oxide (NO) |  | 2 weeks | 
| Home Monitoring Of FEV1 By PIKO Monitors |  | Day 2 to Day 13 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Efficacy, safety, QAV680, pharmacokinetics, corticosteroid, asthma
Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to compare the efficacy of two low-cost low intervention packages to prevent and treat severe anemia in pregnant women in Zanzibar, Tanzania. The two packages are Standard of Care as described by the WHO (presumptive treatment for malaria and helminths plus daily iron + folic acid supplements) and Enhanced Care (Standard of Care plus daily multivitamins and a 2nd dose of anthelminthic.)

Detailed Description
-----------------
This is a clinic-randomized trial involving 8 antenatal clinics and approximately 2500 women. The specific aims are: Aim 1: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the prevention of severe anemia among pregnant Zanzibari women. This aim will be achieved through a pre-post intervention comparison. Aim 2: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to prevent severe anemia among pregnant Zanzibari women. Aim 3: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the cure of severe anemia among pregnant Zanzibari women. Aim 4: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to cure severe anemia among pregnant Zanzibari women.

Official Title
-----------------
Preventing Unnecessary Blood Transfusions in Pregnant Women in Africa Through Effective Primary Health Care

Conditions
-----------------
Anemia, Low Birth Weight, Neonatal Mortality

Intervention / Treatment
-----------------
* Drug: multivitamin, mebendazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant woman Exclusion Criteria: Not a permanent resident of the community
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: multivitamin, mebendazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe anemia (Hb < 7 g/dL) |  |  | 
| Cure of severe anemia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant birth weight |  |  | 
| Neonatal mortality |  |  | 
| Neonatal morbidity |  |  | 
| Blood loss during delivery |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia, Birth weight, Neonatal Mortality, Tanzania, Pregnancy
Prevention of Intradialytic Hypotension in Acute Kidney Injury Patients

Study Overview
=================
Brief Summary
-----------------
Intradialytic hypotension (IH) is a major complication during acute hemodialysis. The aim of this study was to evaluate the effects of dialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling on hemodynamics of critically ill acute kidney injury (AKI) patients submitted to sustained low-efficiency dialysis (SLED).

Official Title
-----------------
Assessment of a Protocol Aiming to Prevent Intradialytic Hypotension in Critically Ill Acute Kidney Injury Patients

Conditions
-----------------
Acute Kidney Injury, Acute Renal Failure

Intervention / Treatment
-----------------
* Procedure: Dialysis
* Procedure: Standard SLED


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute renal failure with a need of dialysis. Exclusion Criteria: Patients with basal serum creatinine > 3 mgdL. Patients submitted to renal transplantation. Patients unlikely to survive. Declination in authorization to participation in the 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Traditional SLED | Procedure: Standard SLED<br> <br> |
| Experimental: Profiling<br>dialysate temperature reduction with Na and ultrafiltration (UF) profiling | Procedure: Dialysis<br>* dialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intradialytic hypotension |  | At dialysis session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dialysis dose |  | dialysis session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypotension, Acute renal failure, acute kidney injury, dialysis, ICU
Effect of Commercial Rye Whole-Meal Bread on Postprandial Blood Glucose and Gastric Emptying in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Increased intake of dietary fibre and whole grains is related to reduced risk of developing diabetes. The term whole grain is often used for whole-meal products in which the structure of the cereal grain is destroyed in the flour containing the original dietary fiber, but also for cereal products in which a large proportion of whole cereal grains is intact. The aim of this study was to evaluate the effect of commercial rye whole-meal bread (RWMB) compared to white-wheat bread (WWB) on gastric emptying rate (GER), postprandial glucose response in healthy subjects.

Detailed Description
-----------------
Ten healthy subjects, without symptoms or a prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus, were assessed by using a blinded crossover trial. The subjects were examined regarding blood glucose levels and GER after ingestion of 150g WWB or RWMB on two different occasions after an overnight fast. GER was measured using a standardized real time ultrasonography. GER was calculated as a percentage change in antral cross sectional area 15 and 90 minutes after the finished meal with WWB and RWMB. Finger-prick capillary samples were collected before and 40, 60, and 90 min after the start of the meal to measure blood glucose levels.

Official Title
-----------------
Effect of Commercial Rye Whole-Meal Bread on Postprandial Blood Glucose and Gastric Emptying in Healthy Subjects

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: without symptoms or a prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus Exclusion Criteria: with symptoms or prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus
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 |
| --- | --- |
| Healthy subjects<br>Healthy subjects, without symptoms or a prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus | |

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
-----------------
rye whole-meal bread, white-wheat bread, gastric emptying rate, postprandial glucose response, healthy subjects
GV 1001 Immunotherapy in Patients With Non-small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
To examine the safety and efficacy of telomerase peptide vaccination ( stimulation of the immune system) in patients with NSCLC after having been treated with conventional therapy with radiotherapy and docetaxel as a radiosensitizer.

Detailed Description
-----------------
Survival in patients with locally advanced, inoperable NSCLC may be improved if local control can be achieved with concurrent chemo radiotherapy .After completed standard chemo-and radiation therapy; the safety and efficacy of vaccination therapy will be measured as time to progression after treatment with GV1001. Analysis of changes in T-cell subpopulations and cytokines in peripheral blood will be performed.

Official Title
-----------------
Immunotherapy in Patients With Non-small Cell Lung Cancer (NSCLC). A Phase II Study of GV 1001 Telomerase Peptide Vaccination in Patients With Locally Advanced NSCLC

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Biological: GV 1001 Telomerase peptide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with inoperable NSCLC, disease stage IIIA and stage IIIB, who has received concurrent chemoradiotherapy( typically docetaxel 20 mg/m2 and 3D radiotherapy, 2Gy x 30 within the last 4 weeks. No sign of brain metastasis( excluded by MRI of the brain) Male or female above the age of 18 years. Normal lab. values

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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: GV 1001 Telomerase peptide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine if combined chemoradiotherapy in patients with NSCLC followed by vaccination( immunotherapy) will increase the immunological response compared to previous experience |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of T cell responders and DTH responders, time to progression of disease |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC, vaccination, Inoperable NSCLC stage IIIA/B in good performance status
Sacral Neuromodulation & Urodynamics

Study Overview
=================
Brief Summary
-----------------
In the field of urology, sacral neuromodulation (SNM) is a well-accepted, second-line, minimally invasive treatment for patients with overactive bladder dry (OABD) or wet (OABW), and for patients with non-obstructive urinary retention (NOUR). Long-term vary between 50-60%. This study examines whether urodynamics can be used as a predictor for successful SNM therapy

Official Title
-----------------
Assessment of Predictive Role of Urodynamics in Sacral Neuromodulation Patients

Conditions
-----------------
Overactive Bladder, Non-obstructive Urinary Retention

Intervention / Treatment
-----------------
* Diagnostic Test: urodynamics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overactive bladder Non-obstructive urinary retention Exclusion Criteria: Neurogenica disorder (e.g. cerebrovascular accident, spinal cord injury)

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Successes<br>Patients with >50% improvement during test procedure of sacral neuromodulation. | Diagnostic Test: urodynamics<br>* Bladder filling and pressure is measured by the insertion of probes within the bladder, urethra and anorectum.<br>* Other names: Slider;|
| Failures<br>Patients with <50% improvement during test procedure of sacral neuromodulation. | Diagnostic Test: urodynamics<br>* Bladder filling and pressure is measured by the insertion of probes within the bladder, urethra and anorectum.<br>* Other names: Slider;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bladder volume | Change in bladder volume is measured before and after test procedure for sacral neuromodulation | 3 weeks | 
| Change in bladder sensation | Bladder sensation is measured by a slider (indicating bladder fullness scaled from 0 to 100) before and after test procedure for sacral neuromodulation | 3 weeks | 
| Change in ice water test | Ice water is infused in the bladder and incontinence upon insertion of the ice water is assessed before and after sacral neuromodulation | 3 weeks |