linjc16/ctgov huggingface dataset:
EFFects of Thrombophilia on the Outcomes of Assisted Reproduction Technologies

Study Overview
=================
Brief Summary
-----------------
Both hereditary and acquired thrombophilia have been associated with recurrent miscarriage and pregnancy complications. Thrombophilia could favor the development of thrombosis of the maternal vasculature and obstacle placentation. Some studies have suggested a role of thrombophilia in the failure of assisted reproductive techniques although this association has been recently questioned. The scope of this study is to evaluate the effect of thrombophilia on the implantation rate and live birth rate in women undergoing ART. Design: prospective, observational study Primary end-point: live birth rate. Secondary end-points: implantation rate, venous thromboembolic events during ART up to 6 weeks post-partum

Official Title
-----------------
EFFects of Thrombophilia on the Outcomes of Assisted Reproduction

Conditions
-----------------
Birth Rate, Embryo Implantation, Reproductive Techniques, Thrombophilia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women undergoing ART age 18 years or older Exclusion Criteria: ongoing anticoagulant therapy previous venous thromboembolism no informed consent

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

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

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 |
| --- | --- | --- |
| Live birth rate |  | Participants will be followed for the duration of the pregnancy, an expected average of 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate |  | Participants will be followed from the implantation to the ultrasonography to document the gestational sac, an expected average of 7 weeks |
Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to characterize the pharmacokinetics of intravenous ceftazidime/avibactam in patients with Cystic Fibrosis.

Detailed Description
-----------------
Cystic fibrosis is a genetic disorder characterized by a chronic cycle of airway infection, obstruction, and inflammation leading to progressive loss of lung function and eventual respiratory failure. The principal pathogen is Pseudomonas aeruginosa which is present in the airways of 70% of adult patients with CF. Of particular concern is the increasing resistance observed to existing agents. While ceftazidime has been the mainstay of treatment for many years, its efficacy is limited by reduced susceptibility. Ceftazidime/avibactam offers a potential advancement in the management of infections involving P. aeruginosa in CF due to its excellent activity, penetration into pulmonary secretions, and reduced potential for development of resistance.

Official Title
-----------------
Steady-state Pharmacokinetics of Ceftazidime/Avibactam in CF

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: Ceftazidime/avibactam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of CF based on positive sweat chloride or know CF mutation Age > 17 years Able to spontaneously expectorate sputum Exclusion Criteria: Any clinically significant laboratory abnormality Presence of an ongoing acute pulmonary exacerbation Pregnancy Serious past allergy to a beta-lactam antibiotic

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV Ceftazidime/Avibactam<br>Ceftazidime/avibactam 2.5gm IV q8h for 3 doses | Drug: Ceftazidime/avibactam<br>* Ceftazidime/avibactam 2.5gm iv q8h for 3 doses<br>* Other names: Avycaz;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) |  | 8 hours | 
| Peak Sputum Concentration |  | 8 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics, ceftazidime/avibactam
Dopaminergic Function and Food Reward

Study Overview
=================
Brief Summary
-----------------
The broad aim of the study is to obtain a better understanding of alterations in mesolimbic reward pathways in adiposity based on the hypothesis of a hypofunctioning reward system in obesity. This will be achieved by integrating a functional neuroimaging (fMRI) with behavioral reward tasks and the modulation of the dopamine level by dopamine depletion.

Conditions
-----------------
Adiposity, Weight Loss

Intervention / Treatment
-----------------
* Dietary Supplement: Dopamine depletion vs. Balanced aminoacid drink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female healthy Exclusion Criteria: fMRI contraindications claustrophobia

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 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 |
| --- | --- |
| subjecst with different BMI<br> | Dietary Supplement: Dopamine depletion vs. Balanced aminoacid drink<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differential brain functions in the dopaminergic reward system | differential brain fuctions will be measured by blood oxygen level dependent effect. | 4 hours after intake of the dopamine depletion or balanced aminoacid drink | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amino acid level changes due to dopamine depletion |  | 4 hours after intake of the dopamine depletion or balanced aminoacid drink |
Fatigue in Rheumatoid Arthritis - Longitudinal Study

Study Overview
=================
Brief Summary
-----------------
To investigate how the fatigue vary over time in persons with rheumatoid arthritis (RA) and which factors that may influence the fatigue.

Official Title
-----------------
Fatigue in Rheumatoid Arthritis - Longitudinal Study

Conditions
-----------------
Fatigue, Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnose of RA, age 20-65 years, Exclusion Criteria: other serious physical or mental illness

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- |
| no intervention<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | patient administered questionnaire | 4 times during the course of the study up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | patient administered questionnaire | 4 times during the course of the study up to one year | 
| Activity limitations | patient administered questionnaire | 4 times during the course of the study up to one year | 
| Disease activity | Tender and swollen joint count, patient-rated global health, inflammation parameters (DAS-28) | 4 times during the course of the study up to one year | 
| Health related quality of life | patient administered questionnaire | 4 times during the course of the study upto one year |
A Study of the Current Medical Practice and Outcomes in the Treatment of Type 2 Diabetes Mellitus in an Office Setting (MK-0431-199)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect information of the risk profile of patients with type 2 diabetes mellitus, their treatment concerning meeting the guidelines for treatment of diabetic patients type 2 published by the Deutsche Diabetes Gesellschaft (DDG) on October 13, 2008

Official Title
-----------------
Standardized Non-interventional Register Investigating the Daily Clinical Practice for the Treatment of Patients With Diabetes Mellitus Type 2 (SIRTA)

Conditions
-----------------
Type 2 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Newly diagnosed with Type 2 diabetes in whom treatment with metformin in the individual maximal tolerated dose (at least four weeks on stable dose) resulted in HbA1c >6.5% - No contraindication or intolerability to metformin Exclusion Criteria: - Currently being administered a combination therapy for the treatment of their Type 2 diabetes

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 |
| --- | --- |
| All Enrolled Participants<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline for Mean Hemoglobin A1c (HbA1C) | Change from baseline was defined as mean HbA1c baseline value minus the mean HbA1c end of observation value. | Baseline and end of Observation (up to Month 6) | 
| Change From Baseline for Mean Fasting Blood Glucose (FBG) | Change from baseline was defined as mean FBG baseline value minus mean FBG end of observation value. | Baseline and end of Observation (up to Month 6) |
A Study of ASP1941 in Participants With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus

Official Title
-----------------
ASP1941 Phase II Clinical Study - A Double-blind, Placebo-controlled, Parallel-group, Dose-response Study in Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Established diagnosis of type 2 diabetes mellitus Fasting serum C-peptide level > 0.6 ng/mL HbA1c between 7.0 and 10.0% Body Mass Index between 20 and 45 kg/m2 Exclusion Criteria: Serum creatinine > upper limit of normal Proteinuria (albumin/creatinine ratio > 300 mg/g) Dysuria and/or urinary tract infection Significant renal, hepatic or cardiovascular diseases Ketosis Hypertension Severe gastrointestinal diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lowest dose | Drug: ipragliflozin<br>* Oral<br>* Other names: ASP1941;|
| Experimental: 2<br>Low-middle dose | Drug: ipragliflozin<br>* Oral<br>* Other names: ASP1941;|
| Experimental: 3<br>High-middle dose | Drug: ipragliflozin<br>* Oral<br>* Other names: ASP1941;|
| Experimental: 4<br>Highest dose | Drug: ipragliflozin<br>* Oral<br>* Other names: ASP1941;|
| Placebo Comparator: 5<br>placebo | Drug: Placebo<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c level |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose level |  | 12 Weeks | 
| Safety |  | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASP1941, Diabetes Mellitus, Type 2
Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection

Study Overview
=================
Brief Summary
-----------------
This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.

Detailed Description
-----------------
This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.The End point is development of contrast-induced nephropathy.

Official Title
-----------------
Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection in Patients Undergoing an Emergent Coronary Procedure

Conditions
-----------------
Emergent Coronary Procedure

Intervention / Treatment
-----------------
* Drug: Sodium bicarbonate
* Drug: Sodium Chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing an emergent coronary procedure(within 60 minutes from admission) Exclusion Criteria: On dialysis Pregnancy Past use of bicarbonate or N-Acetyl-Cystein in 48hr Past exposure to contrast media in 48hr Circulatory insufficiency with lactic acidosis.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium bicarbonate<br> | Drug: Sodium bicarbonate<br>* 8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure<br>|
| Experimental: Sodium chloride<br> | Drug: Sodium Chloride<br>* 8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Contrast-induced Nephropathy | The primary endpoint was the occurrence of contrast-induced nephropathy, defined as an increase >0.5 mg/dl or >25% in serum Cr concentration within 2 days of the procedure compared to the baseline level. | after procedure and 1,2-3day after procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients undergoing an emergent coronary procedure
The Genetics of Kidneys in Diabetes (GoKinD) Study

Study Overview
=================
Brief Summary
-----------------
Kidney disease in diabetes (diabetic nephropathy) tends to run in families. It is likely, therefore, that there are genes that predict or are associated with either getting or not getting diabetic nephropathy. The GoKinD Study will provide clinical information and DNA for investigators to look for these genes. Evaluation will be performed and DNA obtained from approximately 1100 diabetic persons with kidney disease and 1000 diabetic persons without kidney disease. In some cases, samples for DNA will also be obtained from the parents of these subjects. Clinical information and DNA will be coded so that individuals cannot be identified, but the DNA can be linked to the clinical data from the individual. Multiple investigators will be able to use this genetic material to test hypotheses about the genetics of kidney disease in diabetes.

Official Title
-----------------
The Genetics of Kidneys in Diabetes (GoKinD) Study

Conditions
-----------------
Diabetic Nephropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Type 1 diabetes mellitus with or without diabetic nephropathy; 19-54 years old; no other kidney disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 54 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 |
| --- | --- | --- |
Single Ascending Dose Study With BPL-003 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The study will evaluate safety, tolerability and PK profile of BPL-003 in healthy subjects

Official Title
-----------------
A Two-part Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Intranasal BPL-003 (5-Methoxy-N,N-dimethyltryptamine Benzoate) in Healthy Subjects

Conditions
-----------------
Pharmacokinetics in Healthy Adults

Intervention / Treatment
-----------------
* Drug: BPL-003
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medically healthy based on medical records and study specific assessments Exclusion Criteria: Presence or history of severe adverse reaction to any drug or drug excipient

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BPL-003 arm<br> | Drug: BPL-003<br>* A single dose of BPL-003 will be administered intranasally<br>|
| Placebo Comparator: Placebo arm<br> | Other: Placebo<br>* A single dose of placebo will be administered intranasally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with treatment emergent AEs (TEAES) |  | From screening through to the follow up visit, up to 65 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) |  | Day 1 (dosing day) and Day 2 | 
| Time to reach Cmax (tmax) |  | Day 1 (dosing day) and Day 2 | 
| Area under the plasma concentration- time curve |  | Day 1 (dosing day) and Day 2 |
Prevalence of Asymptomatic Thrombosis in Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
Malignant hemopathies, such as solid cancers, increase the risk of venous and arterial thromboembolic events. The incidence of symptomatic venous thromboembolic events is particularly high in myeloma, linked to the usual risk factors for venous thromboembolic disease, biological risk factors specific to myeloma, and especially to its treatments. The prevalence of asymptomatic venous thromboembolic events and arterial events are not known to date and remain important data for planning a possible randomized study to determine the most suitable thromboprophylaxis in these patients.

Official Title
-----------------
Prevalence of Asymptomatic Thrombosis in Multiple Myeloma

Conditions
-----------------
Thrombosis, Multiple Myeloma

Intervention / Treatment
-----------------
* Other: Echoing of the lower limbs and measuring the systolic pressure index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient major age ≥18 years Patients with symptomatic myeloma meeting the definition of the International Myeloma Working Group, regardless of the therapeutic line, including patients in remission and untreated. Patient having given informed consent, signed. Patient benefiting from a social security scheme Exclusion Criteria: Patients with non-symptomatic myeloma (stage I) or gammapathy of unknown significance (MGUS). Patient undergoing antithrombotic treatment for deep or superficial venous thrombosis and / or pulmonary embolism at the time of inclusion. Patients with occlusive arterial disease of the lower limbs known at the time of inclusion. Minors, protected adults and patients deprived of liberty or not affiliated to a social security scheme Pregnant woman Patient unable to express consent. Patient under guardianship or curatorship or patient deprived of public liberty

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient with multiple symptomatic myeloma<br> | Other: Echoing of the lower limbs and measuring the systolic pressure index<br>* Echoing of the lower limbs and measuring the systolic pressure index<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the occurrence of venous thromboembolic events via transverse Doppler echo |  | 1 day |