linjc16/ctgov huggingface dataset:
Influence of a Prematuration Culture With a Phosphodiesterase-3 Inhibitor (PDE3-I) on Embryonic Aneuploidy Rate and Developmental Potential

Study Overview
=================
Brief Summary
-----------------
A single centre randomised controlled trial investigating the influence of a novel prematuration system (PMS) using a phosphodiesterase-3 inhibitor for in-vitro maturation of oocytes - pilot study.

Official Title
-----------------
Influence of a Prematuration Culture With a PDE3-I on Embryonic Aneuploidy Rate and Developmental Potential - a Pilot Study

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: prematuration culture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers, either with PCOS/PCOS-like ovaries, or with normal ovaries, who undergo oocyte donation for research AFC at least 10 AMH: > 5 μg/L Female age < 36 years Exclusion Criteria: major uterine or ovarian abnormalities

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?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: in-vitro maturation of oocytes<br> | Procedure: prematuration culture<br>* The aneuploidy rate and the developmental potential of embryos obtained from PDE3 inhibitor-treated oocytes (a prolonged IVM (PMC)) in comparison to conventional IVM will be analysed. It is intended to assess the nuclear and cytogenetic constitution of the obtained embryos.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of aneuploidy rate by fluorescence in situ hybridisation (FISH) technique in 6 to 8 cell embryos from prolonged (PMC) IVM compared to conventional IVM on sibling oocytes. |  | 3 days after egg retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation potential of embryos from conventional IVM performed on Type II COC. Efficiency of both maturation systems in obtaining blastocysts. Endometrium quality in IVM cycles. |  | 7 days after egg retrieval | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS and normal ovulatory patients, aneuploidy, in-vitro maturation of oocytes
Switching From Morphine to Oral Methadone Plus Acetaminophen in the Treatment of Cancer Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether oral methadone plus acetaminophen can substitute morphine in the treatment of cancer pain.

Detailed Description
-----------------
Opioids are the mainstay of moderate-to-severe cancer pain management. Although morphine is the most commonly used, methadone has some advantages such as higher potency, lower cost and longer administration intervals. To minimize the time necessary to achieve the equianalgesic effect after a switching from morphine to methadone, acetaminophen was added in the treatment.

Official Title
-----------------
Switching From Morphine to Oral Methadone Plus Acetaminophen in the Treatment of Cancer Pain: A Randomized, Double-Blind Study

Conditions
-----------------
Cancer, Pain, Palliative Care

Intervention / Treatment
-----------------
* Drug: Methadone plus Acetaminophen or Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of cancer pain Regular use of oral Morphine Exclusion Criteria: Use of Acetaminophen in the last 48 hours Renal or Hepatic failure

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Methadone plus Placebo | Drug: Methadone plus Acetaminophen or Placebo<br>* Methadone bid according to a established conversion morphine-to-methadone ratio plus Placebo or Acetaminophen qid<br>|
| Experimental: 2<br>Methadone plus Acetaminophen | Drug: Methadone plus Acetaminophen or Placebo<br>* Methadone bid according to a established conversion morphine-to-methadone ratio plus Placebo or Acetaminophen qid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity and time to equianalgesic effect |  | within the first 7 days after switching | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of nausea, vomiting, obstipation, xerostomia and drowsiness |  | within the first 7 days of switching | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Methadone, Cancer Pain, Morphine, Acetaminophen, Palliative Care
Pulmonary Complications of Allografts

Study Overview
=================
Brief Summary
-----------------
This is a prognostic study of the late lung complications arising at the patient's having received an allograft of hematopoetic stem cells.

Detailed Description
-----------------
Objectives To estimate the incidence of late (at least occurring 100 days after transplantation) pulmonary complications following allogeneic blood stem cells transplantation Study Design Prospective Cohort Study All follow-up data were actualiized in September, 2016. Sample Size 200 transplanted patients Main Endpoint Non infectious pulmonary complications within the first 3 years

Official Title
-----------------
Prospective Cohort Study of Late Pulmonary Complications in Patients Who Received Allogeneic Hematopoietic Stem Cells Transplantation: Estimation of Incidence and Identification of Distinct Nosologic Entities

Conditions
-----------------
Pulmonary Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allogeneic Blood stem cell transplantation Alive at day 100 post-transplant Exclusion Criteria: Non informed consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Allografted patients<br>All consecutive patients who underwent an allogeneic blood stem cells transplantation performed at saint Louis hospital during the study recruitment period if alive at 100 days post-transplant and who gave informed consent | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non infectious pulmonary complication |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival after non infectious pulmonary complication |  | 3 years and 10 years | 
| Overall survival |  | 3 years and 10 years | 
| Long term time course of Pulmonary Function Tests (PFTs) |  | 3 years and 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone marrow transplant, Pulmonary complications
Retrospective Survey for Patients With Hypertension and Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study will address the treatment rate and control rate of hypertension, treatment pattern and factors to affect blood pressure control by examining (retrospective) medical records of hypertension patients having Type 2 Diabetes mellitus, among outpatients coming to the Endocrinology Department in 20 general hospital settings nationwide.

Official Title
-----------------
A Retrospective, Multi Centre, Non-interventional, Observational Study to Investigate Treatment Pattern of Blood Pressure in the Type II Diabetes Mellitus Patients With Hypertension.

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatient Type II DM patients receiving hypertension medication in 2006 Patient with Type II DM receiving hypertension medication during at least 1 year. Exclusion Criteria: Secondary hypertension patients Patients not receiving hypertension medication

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 |
| --- | --- |
| 1<br>Hypertension patients with Type II Diabetes mellitus | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attainment rate to the target blood pressure. |  | After collecting all Patient Record Form. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dropout rate will be estimated during the follow-up period after the hypertension treatment. Attainment to the target blood pressure will be investigated according to concomitant diseases. |  | After collecting all Patient Record Form. | 
| Change in DBP/SBP value during the follow-up period will be addressed. Change in the DBP/SBP value will be investigated according to the risk factors and concurrent disease. |  | After collecting all Patient Record Form. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Type II DM, JNC7, 2007 ESH-ESC guidelines, survey
The Influence of Preoperative Cardiopulmonary Capacity on the Perioperative Lactate Level

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify if there exists a correlation between the preoperative cardiopulmonary capacity - measured in MET's - and the perioperative lactate serum level.

Detailed Description
-----------------
The determination of the cardiopulmonary (c/p) capacity is very important for the evaluation of every patient undergoing surgery. The ability to climb at least two flight of stairs is seen to be an acceptable c/p capacity for surgery. There are several ways to evaluate the fitness of patients. A common method to estimate the cardiopulmonary capacity is defining patients through the MET's (metabolic equivalents) scale. MET's can be defined relatively easy through a simple questionnaire. Patients with a reduced c/p capacity have less than 4 MET's, patients with a relatively good c/p capacity have 4-10 MET's and patients with a excellent c/p capacity have more than 10 MET's. The lactate level in blood serum is a common parameter to asses anaerobic metabolism in patients. A high lactate level correlates with higher mortality rates and outcome. To yet it is not clear if there exists a correlation between the preoperative cardiopulmonary capacity measured in MET's and the perioperative lactate level. We hypothysed that patients with a reduced cardiopulmonary capacity are associated with higher perioperative lactate levels, as these group of patients compensate the stressors operation/anesthesia less than patients with a good c/p capacity.

Official Title
-----------------
The Influence of Preoperative Cardiopulmonary Capacity Mesured in MET's (Metabolic Equivalents) on the Perioperative Lactate Level

Conditions
-----------------
Sensitivity Training Groups, Complication, Cardio-respiratory

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Exclusion Criteria: Cardiac surgery

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 |
| --- | --- | --- |
| lactate - venous blood gas analysis | mmol/l | venous lactate will be measured at anaesthesia induction and anesthesia termination - the average time frame is 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| icu in hospital mortality |  | icu patients will be followed over their hospital stay over a maximum period of 6 months | 
| hemoglobin - venous blood gas analysis | g/dl | hemoglobin will be measured at anaesthesia induction and anesthesia termination - the average time frame is 2 hours | 
| icu ventilation time | hours/days | icu patients will be followed over their hospital stay over a maximum period of 6 months |
Drug-Drug Interaction Study in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of clarithromycin on the pharmacokinetics of K-877 in healthy adult subjects.

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

Intervention / Treatment
-----------------
* Drug: K-877
* Drug: Clarithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening. Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening. Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening. Exclusion Criteria: Subject has clinically relevant abnormalities in the screening or check in assessments. Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females). Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K-877<br>K-877 | Drug: K-877<br> <br> |
| Experimental: K-877 with Clarithromycin<br>K-877 with Clarithromycin | Drug: K-877<br> <br> Drug: Clarithromycin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under concentration curve (AUC) |  | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult Volunteers
Incidence of MRI Sacro-Iliac (SI) Joint Anomalies in Women With Spondyloarthritis (SpA)

Study Overview
=================
Brief Summary
-----------------
Retrospective study comparing the incidence of inflammatory and structural lesions seen on MRI of the sacro-iliac (SI) joints in a population of women affected by spondyloarthritis (SpA) and control women population (MISIA study NCT02956824). A previous study (MISIA) demonstrate SpA may be misdiagnosed on MRI in postpartum women due to increased stress on the joint following pregnancy and childbirth, as MRI of the SI joints may show lesions that could mimics SpA. The primary objective of this study is to compare the incidence and pattern of MRI inflammatory and structural lesions of the SI joints between SpA and control women, and determine differentiation criteria in SpA women.

Official Title
-----------------
Incidence of Sacro-iliac (SI) Joint Anomalies on MRI: Differentiation Criteria in Women With Spondyloarthritis (SpA

Conditions
-----------------
Spondylarthritis

Intervention / Treatment
-----------------
* Other: Medical Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Women aged 18 to 50 years old SpA diagnosed Pelvis MRI performed Exclusion criteria: - Pelvis MRI unavailable

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SpA women MRI<br>Women affected by spondyloarthritis and performed a sacroiliac MRI | Other: Medical Imaging<br>* MRI imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of MRI inflammatory of the sacroiliac joints | MRI inflammatory of the sacroiliac joints in the population of women affected by SpA | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of structural lesions of the sacroiliac joints | structural lesions of the sacroiliac joints in the population of women affected by SpA | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnostic Imaging, Magnetic Resonance Imaging, Sacroiliac Joint anomalies
COVID Booster in Pregnancy and Lactation

Study Overview
=================
Brief Summary
-----------------
This is a prospective longitudinal cohort study to evaluate the impact of COVID-19 vaccination and booster on maternal and infant immunity against COVID-19 variants over time.

Detailed Description
-----------------
We will enroll 100 pregnant patients who have received COVID-19 mRNA booster as well as 100 breastfeeding patients who have received COVID-19 mRNA booster. Participants will be following longitudinally through 3 months post partum, or 3 months post enrollment for those in the breastfeeding cohort. Maternal blood will be collected, as will cordblood at delivery, breastmilk, and infant samples.

Official Title
-----------------
Serological and Functional Impact of COVID-19 Vaccination on the Maternal Fetal Unit and Infant Immunity

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

Intervention / Treatment
-----------------
* Drug: Bivalent COVID-19 Booster


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton gestation Received mRNA bivalent COVID-19 booster during 1) pregnancy or 2) breastfeeding Exclusion Criteria: Multifetal gestation Unable to provide consent

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 55 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 |
| --- | --- |
| COVID-19 booster in pregnancy<br>Pregnant singletons who have received COVID-19 booster in pregnancy | Drug: Bivalent COVID-19 Booster<br>* Bivalent COVID-19 Booster by Pfizer or Moderna<br>|
| COVID-19 booster in breastfeeding<br>Breastfeeding individuals who have received COVID-19 booster while breastfeeding | Drug: Bivalent COVID-19 Booster<br>* Bivalent COVID-19 Booster by Pfizer or Moderna<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Serological Profile | Quantitative Maternal IgG to SARS CoV2 spike and other domains | 3 months | 
| Maternal Functional Immunity | Quantitative Antibody neutralization capacity | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant serological profile | Quantitative IgG to SARS CoV2 | 3 months old | 
| Infant functional immunity | Quantitative Antibody neutralization capacity | 3 months old | 
| Breastmilk serological profile | Quantitative IgA to SARS CoV2 | 3 months | 
| Infant oral immunity | Quantitative Salivary SARS CoV2 IgG | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaccine, COVID-19 vaccine, booster, pregnancy, breastfeeding, immunity
Wholebody MRI In Lung Cancer StagiNg

Study Overview
=================
Brief Summary
-----------------
Magnetic Resonnace Imaging (MRI) and Positron Emission Tomography (PET) can be both used in detection of nodes in patients with cell lung cancer (NSCLC). However, the cardiorespiratory synchronization in the MRI, allowing acquisition of synchronous images with breathing and heart movements should increase the sensitivity of detection of pathologic mediastinal lymph nodes. Given its high sensitivity, whole-body MRI with diffusion could possibly be at least as informative as PET, while being less expensive, not radiant. The purpose of this study is to evaluate the performance of whole-body MRI with diffusion with cardiorespiratory synchronization, on the detection of mediastinal nodes (which are known to be less well detected by MRI) compared to PET.

Official Title
-----------------
Initial Staging of Bronchopulmonary Neoplasia: Whole-body MRI Versus Pet Scanner

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Device: MRI
* Device: PET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years, Neoplasia bronchopulmonary (SCLC and NSCLC) newly diagnosed, Patient potentially eligible for curative treatment, but no no treatment started, Patients for whom a PET scan and MRI are planned Non Inclusion Criteria: claustrophobia, Implantable Medical Device not compatible pacemaker type or heart valve, metal splinters eye) Pregnant or lactating women,

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI<br>Wholebody MRI with cardio-pulmonary synchronization At day 1 , at the afternoon, patient will undergo an MRI analysis. | Device: MRI<br>* Whole body MRI with cardiac and pulmonary synchronization<br>|
| Active Comparator: PET<br>At day 1 , in the morning, patient will undergo an PET analysis | Device: PET<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Th consistency of the locations of mediastinal lesions | Node localization according to MRI and PET scan measurements on the same day | Day 1 |