linjc16/ctgov huggingface dataset:
Progesterone Variation on the Final Day of Oocyte Maturation.

Study Overview
=================
Brief Summary
-----------------
The current study, aims through a robust design to provide a simple answer on whether progesterone levels of the same individual may significantly vary depending on the time of blood retrieval before the ovulation triggering, by evaluating the daily variability of serum progesterone on the day of triggering in healthy women who perform a COS for oocyte donation, through multiple blood samplings.

Official Title
-----------------
Progesterone Variation on the Final Day of Oocyte Maturation. A Prospective Cohort Study With Repeated Measurements

Conditions
-----------------
Controlled Ovarian Stimulation, Progesterone Variation on Trigger Day, Circadian Rhythm, Oocyte Donors

Intervention / Treatment
-----------------
* Diagnostic Test: Serum progesterone measure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy oocyte donors according to spanish law for oocyte donation Controlled ovarian stimulation following a flexible antagonist protocol and stimulation with recombinant Follicular stimulating hormone. Informed consent signed Exclusion Criteria: Detection of luteinizing hormone surge before triggering

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 donors<br>Healthy oocyte donors undergoing ovarian stimulation with recombinant Follicular stimulating hormone | Diagnostic Test: Serum progesterone measure<br>* Serum Progesterone will be measured in all donors on the day triggering at 8:00 am, 12:00 p, 16:00 pm and 20:00 pm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progesterone variation among 4 different moments on the day of ovulation triggering | Measurement of serum Progesterone (ng/ml) in each oocyte donor at 4 different times on the day of ovulation triggering: The primary outcome will be the variation among the 4 progesterone measurements for each patient within the fixed12 hours time (8:00am; 12:00pm; 4:00pm and 8:00pm). | Progesterone will be measured 4 times on the day of ovulation triggering, each of them separated 4 hours from the previous one (total 4 samples within 12 hours): blood samples will be obtained at 8:00 am, 12:00 pm, 4:00 pm and 08:00 pm |
Prevalence of Severe Bleeding in COVID-19 Patients Treated With Higher Than Recommended Thromboprophylaxis Doses

Study Overview
=================
Brief Summary
-----------------
The main objectives are: To establish the prevalence of major bleeding in patients treated with higher than recommended thromboprophylaxis doses. To identify variables associated to higher risk of bleeding.

Official Title
-----------------
Prevalence of Severe Bleeding in COVID-19 Patients Treated With Higher Than Recommended Thromboprophylaxis Doses (BLEEDING Study)

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients infected with COVID-19 treated with higher than recommended thromboprophylaxis doses. Admission to hospital. Exclusion Criteria: Patients treated with ECMO (Extracorporeal membrane oxygenation).
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 |
| --- | --- | --- |
| Bleeding events and complications | Study endpoints are clinically recognized (and objectively confirmed) major and minor bleeding complications, and death. | 30 days |
Integrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program

Study Overview
=================
Brief Summary
-----------------
The goals of this work will be to evaluate the preliminary efficacy of a comprehensive pre-dialysis education program on increased knowledge of conservative kidney management and advance care planning among patients with advanced CKD.

Detailed Description
-----------------
This intervention will be randomized among patients with advanced chronic kidney disease.

Official Title
-----------------
Integrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program

Conditions
-----------------
Advance Care Planning, Chronic Kidney Diseases, Conservative Kidney Management

Intervention / Treatment
-----------------
* Other: ESRD education + conservative kidney management and ACP education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage 4 or 5 CKD (defined by the CKD-EPI estimation of GFR < 30 ml/min/1.73m2) Age 65 years or greater or frail self-reported Black or White race Exclusion Criteria: History of dementia History of legal blindness Listed for kidney transplantation

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comprehensive pre-dialysis program incorporating conservative and advance care planning education
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard pre-dialysis education<br>Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation | |
| Active Comparator: ESRD education + ACP<br>Standard ESRD education + conservative kidney management and advance care planning education | Other: ESRD education + conservative kidney management and ACP education<br>* Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of conservative kidney management and advance care planning | Change in knowledge of conservative kidney management and advance care planning (mean score) | Baseline and Day 1 post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Communication of EOL preferences with healthcare providers and family members | Binary outcome (yes/no) | 12 weeks post-intervention |
Cortical Excitability Using Transcranial Magnetic Stimulation and Neuronavigation Device

Study Overview
=================
Brief Summary
-----------------
This study has two main goals : to investigate the impact of aging on cortical excitability (CE) to investigate the impact of state dependency on CE, using a cognitive task and an emotional one. A Neuronavigation system of transcranial magnetic stimulation is used, and electromyographic response are recorded.

Official Title
-----------------
Study of Cortical Excitability in Healthy Subjects With Transcranial Magnetic Stimulation (TMS) and a Neuronavigation Device

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Device: TMS Magpro®, Magventure Inc device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female age 18-75 signed informed consent normal physical examination Exclusion Criteria: less 18 or more 75 years of age contra indication to TMS: epilepsia or seizures, metallic head devices, cardiac pacemaker, pregnancy, jet lag or severe insomnia the night before severe physical disease treatment with psychotropic drugs overt psychiatric disease alcohol consumption before the examination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: state dependency TMS<br>TMS performed at rest and during a cognitive/emotional task | Device: TMS Magpro®, Magventure Inc device<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitudes of Motor evoked Potentials (µV) for ICI and ICF. | Motor Evoked Potential (MEP) from the first dorsal interosseous are register during the stimulations. Intracortical Inhibition (ICI) and Facilitation (ICF) are a paired-pulse TMS measure of cortical excitability. A short Interval interstimuli (2ms) leads to a cortical inhibition, which reflects the GABAergic neurotransmission; whereas a longer interval interstimuli leads to a cortical facilitation, which reflects glutamatergic neurotransmission. | Participants will be followed for an expected average of one month | 
| Durations of Cortical Silent Period (ms) | Cortical Silent Period (CSP) is a single-pulse TMS measure of cortical inhibition, stimulations are applied while subjects are exerting a muscular contraction of the thum-index pinch and lead to a muscular cancellation. Duration of this silence is measured. | Participants will be followed for an expected average of one month |
Study of the Environmental Factors Modulating Children Immune Response in Northern Senegal

Study Overview
=================
Brief Summary
-----------------
Longitudinal survey in Northern Senegal to investigate the environmental factors modulating the immune response to childhood vaccines and to malaria. A cohort of 410 children aged 1 to 10 from 5 villages of the Senegal River Valley(Podor District) was followed-up for 18 months. During that period, 5 visits have been made to the villages to assess the immunological and nutritional status of the children.

Detailed Description
-----------------
Longitudinal survey in Northern Senegal to investigate the environmental factors modulating the immune response to childhood vaccines and to malaria. A cohort of 410 children aged 1 to 10 from 5 villages of the Senegal River Valley(Podor District) was followed-up for 18 months. During that period, 5 visits have been made to the villages to assess the immunological and nutritional status of the children (T1 (October 2008), T2 (January 2009), T3 (June 2009), T4 (October 2009) and T5 (January 2010)). The project was approved by the National Ethics Committee of Senegal. Written individual informed consent was obtained from each participant's parent or legal guardian at the beginning of the survey, and at each visit child's and parent's approval was sought orally. Capillary blood was collected from the finger tip of each child, using sterile single-use material. Body temperature was measured by means of auricular thermometer at all visits. Anthropomorphic data were collected at visits T2, T3, T4 and T5. A Hemocue photometer (HemoCue AB, Ängelholm, Sweden) was used to determine haemoglobin concentration on a blood drop at visits T3, T4 and T5. At each visit, a questionnaire was filled in for every child. Information was collected on the date of birth family membership to asses if siblings or children living in the same house were in the cohort.

Official Title
-----------------
Study of the Environmental Factors Modulating Children Immune Response in Northern Senegal

Conditions
-----------------
Whooping Cough, Malaria, Malnutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: between 1 and 10 years Exclusion Criteria: Fever (body temperature superior to 38.5 °C)

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, Immunity, Sub-Saharan, Pertussis, Malaria, Nutrition, antibodies
Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients With Sensitive Small Cell Lung Cancer (SCLC)

Study Overview
=================
Brief Summary
-----------------
This is a Phase II, open-label, multicenter, single-arm, exploratory proof of concept study. Diflomotecan (7 mg fixed dose) will be administered as a 20-minute IV infusion once every 3 weeks in patients with sensitive small cell lung cancer (SCLC) with progressive disease after first-line treatment with a platinum-based regimen.

Official Title
-----------------
A Phase II Open Label Study Investigating the Activity of Diflomotecan (BN80915) Administered at the Fixed Dose of 7mg as a 20 Minute Intravenous Infusion Once Every 3 Weeks in Patients With Sensitive Small Cell Lung Cancer (SCLC) Who Have Failed First-line Treatment With a Platinum Based Regimen.

Conditions
-----------------
Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Diflomotecan (BN80915)


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Documented small cell lung cancer (SCLC) Measurable disease One line of previous chemotherapy, including any platinum analogue, and excluding any camptothecin analogues, with objective response and relapsed no less than 3 months Main Exclusion Criteria: Uncontrollable brain metastasis Treated with an investigational drug within 30 days

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 |
| --- |
|Drug: Diflomotecan (BN80915)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall objective response rate (tumour assessments should be performed every 6 weeks) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to tumour progression |  |  | 
| Time to treatment failure |  |  | 
| Duration of overall response |  |  | 
| Overall complete response, partial response and stable disease |  |  | 
| Time to response |  |  | 
| Six month and one year survival rates |  |  | 
| Median survival |  |  | 
| Best overall response |  |  | 
| Overall objective response rate |  |  |
48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.

Official Title
-----------------
A 48 Week, Open Label, Non-Comparative, Multicentre, Phase IIIb Study to Evaluate the Efficacy and Safety of the Lipid-Regulating Agent Rosuvastatin in the Treatment of Subjects With Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous Familial Hypercholesterolaemia.

Conditions
-----------------
Dyslipidaemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Behavioral: Maintenance of specific diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasting low density lipoprotein level as defined by the protocol. Fasting triglyceride level as defined by the protocol. Exclusion Criteria: The use of lipid lowering drugs or dietary supplements after Visit 1. Active arterial disease eg Unstable angina, or recent arterial surgery. Blood lipid levels above the limits defined in the protocol. Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosuvastatin|nan|
|Behavioral: Maintenance of specific diet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in low density lipoprotein cholesterol levels |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in low density lipoprotein cholesterol levels |  | 24 & 48 weeks | 
| Safety: adverse events & abnormal laboratory markers |  | 4 weekly until week 12 then 12 weekly thereafter. | 
| Maintenance of lowered low density lipoprotein cholesterol level |  | Between week 12-48 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor
Safety and Efficacy Pilot Study of AzaSite® for Four Weeks in Subjects With Blepharitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs and symptoms of blepharitis.

Official Title
-----------------
A Single-Center, Open-Label, Randomized Pilot Study of the Safety and Efficacy of AzaSite® Ophthalmic Solution, 1% in Combination With Mechanical Therapy Versus Mechanical Therapy Alone for Four Weeks in Subjects With Posterior Blepharitis

Conditions
-----------------
Blepharitis

Intervention / Treatment
-----------------
* Drug: AzaSite®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of moderate to severe chronic posterior blepharitis If female of childbearing potential, are non-pregnant and non-lactating Exclusion Criteria: had ocular surface surgery (LASIK, refractive, pterygium) within the past year unwilling to discontinue use of contact lenses during the study have glaucoma unable or unwilling to withhold the use of eyelid scrubs during the study have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AzaSite® | Drug: AzaSite®<br>* Ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for  26 days<br>|
| No Intervention: 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical signs and symptoms associated with blepharitis |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard ocular safety assessments |  | 4 weeks |
A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.

Official Title
-----------------
An Exploratory Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Design Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD1722 in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria

Conditions
-----------------
Chronic Kidney Disease, Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: AZD1722
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females aged 18 to 80 years, inclusive. Body mass index between 18 and 45 kg/m2, inclusive. Type 2 diabetes mellitus and receiving ≥1 glucose lowering medication for at least 3 months prior to randomization Stage 3 CKD MSSBP ≥130 mmHg Urinary albumin: mean UACR ≥ 200 mg/g Exclusion Criteria: Urinary albumin: UACR > 3500 mg/g History of a renal transplant MSSBP >180 mmHg or a MSDBP of >120 mmHg on two occasions during screening or run-in periods History of inflammatory bowel disease or diarrhea predominant irritable bowel syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AZD1722<br>AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks | Drug: AZD1722<br> <br> |
| Placebo Comparator: Placebo<br>Placebo capsule BID PO for 12 Weeks | Drug: Placebo<br>* Placebo for AZD1722<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Urine Albumin to Creatinine Ratio (UACR) | The difference between tenapanor and placebo in the change in UACR from baseline to the end of 12 weeks of treatment | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
albuminuria