linjc16/ctgov huggingface dataset:
Evaluation of the BRADA and ABILHAND Questionnaires

Study Overview
=================
Brief Summary
-----------------
This protocol is designed to evaluate the BRADA and ABILHAND questionnaires in rheumatoid arthritis (RA) patients that will be treated with an effective therapy. Patients with moderate to severe RA treated with tocilizumab will be asked to complete the BRADA and ABILHAND questionnaires at screening, baseline, after 12 weeks and after 24 weeks of treatment. All other assessments and questionnaires from daily clinical practice (such as the global assessment of disease activity by the patient, the Health Assessment Questionnaire (HAQ), the SF36 questionnaire, measurement of ESR and CRP and the DAS 28 calculation), will also be used to evaluate these questionnaires.

Official Title
-----------------
Prospective, Multicenter, Non-interventional Study in RA Patients Treated With Tocilizumab - Evaluation of the BRADA and ABILHAND Questionnaires

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with moderate to severe RA. Inadequate response on earlier optimal use of a minimum of two DMARDs (disease modifying anti-rheumatic drugs such as goldsalts, salazopyrine, leflunomide, methotrexate (MTX)) as far as one of the two used DMARDs is MTX that at the exception of a documented intolerance despite the association with folic acid, should have been administered IM or oral during a minimum of 3 months and at a minimal dose of 15mg/week. DAS 28 score ≥ 5.1 For whom a drug that is registered for the treatment of moderate to severe RA is commercially available but does not constitute a satisfactory treatment for this patient.

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 |
| --- | --- |
| Patients with moderate to severe RA<br>Patients with moderate to severe RA treated with Tocilizumab | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the BRADA and ABILHAND questionnaires to detect clinically important changes over time. |  | after 24 weeks of treatment with tocilizumab | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with moderate to severe RA
Measurement of Fibroid Volume and 2D, 3D US

Study Overview
=================
Brief Summary
-----------------
Objective: To compare 2-dimensional and 3-dimensional ultrasound measurements with the actual myomas volume after surgical removal, to clinically test the validity and usability of 3D ultrasound technology as opposed to conventional 2D real-time ultrasound and to assess the reliability of different ultrasound methods to measure volume of uterine fibroids.

Official Title
-----------------
Uterine Fibroid Volume After Myomectomy Compared to Pre-operative Measurement by Two and Three-dimensional Ultrasound

Conditions
-----------------
Gynecology

Intervention / Treatment
-----------------
* Other: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgical intervention Exclusion Criteria: unfit for surgery

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- |
| 2D ultrasound<br>2D-US measurements are the most accurate method for measuring fibroid volumes | Other: ultrasound<br> <br> |
| 3D ultrasound<br>3D-US measurements are the most accurate method for measuring fibroid volumes | Other: ultrasound<br> <br> |
| postoperative<br>actual volume using change in water path measurements are the most accurate method for measuring fibroid volumes | Other: ultrasound<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measuring fibroid volumes |  | 2012-2015 |
Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver Transplantation

Detailed Description
-----------------
This Study Aims to Evaluate:- Quality of life after LDLT In Egyptian patients using short form 36 (SF - 36) score. Impact of post transplant medical and psychiatric complications on quality of life

Conditions
-----------------
Health Related Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Egyptian patients 18-60 years old Patients transplanted for HCV related disease and /or HCC Informed consent Exclusion Criteria: Other etiologies for end stage liver disease (such as HBV and cholestatic liver disease and autoimmune hepatitis).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Recipients of Living Donor Liver Transplantation<br>Patients who will undergo Living Donor Liver Transplantation (LDLT) In Ain Shams Center For Organ Transplantation (ASCOT) . | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life after LDLT In Egyptian patients using short form 36 (SF - 36) score. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of post transplant medical and psychiatric complications on quality of life |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health Related Quality of Life (HRQL), Living Donor Liver Transplantation(LDLT)
An Observational Study on Efficacy and Safety in Subjects Using Levemir® for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This observational study is conducted in Africa. The aim of this observational study is to evaluate the efficacy and the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions.

Official Title
-----------------
Efficacy and Safety Study of Levemir® (Insulin Detemir) to Treat Type 1 and 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any subject with Type 1 or Type 2 diabetes mellitus is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician Exclusion Criteria: Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit Currently being treated with insulin detemir Previously enrolled in this study Hypersensitivity to insulin detemir or to any of the excipients Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures.

Ages Eligible for Study
-----------------
Minimum Age: 7 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 |
| --- | --- |
| A<br> | Drug: insulin detemir<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>* Other names: Levemir®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of serious adverse drug reactions, including major hypoglycaemic events |  | From baseline to 12 and 24 weeks of Levemir® therapy, respectively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse events |  | From baseline to 12 and 24 weeks of Levemir® therapy, respectively | 
| Number of all adverse events |  | From baseline to 12 and 24 weeks of Levemir® therapy, respectively | 
| Number of all hypoglycaemic events |  | in the 4 weeks preceding the visits at 12 weeks and 24 weeks. | 
| Weight changes |  | at the end of study | 
| HbA1c |  | at the end of study | 
| Sub -group analysis of hypo risk |  | From baseline to 12 and 24 weeks of Levemir® therapy, respectively |
Anticoagulation and Activation - Comparison in Continuous Renal Replacement Therapy

Study Overview
=================
Brief Summary
-----------------
Actual clinical practice predominantly makes use of heparin (systemically) or citrate regionally as anticoagulation in the extracorporeal circulation for renal replacement therapy. We aim to find out if different anticoagulation strategies may lead to different levels of platelet activation and whole blood coagulation. Regarding coagulation activation, it remains uncertain if there is an advantage for one of these methods. However, it is of major interest to minimize the risk of any additional clotting activation via extracorporeal circulation in these usually critically ill patients.

Official Title
-----------------
Platelet Function, Whole Blood Coagulation and Fibrinolysis During Continuous Renal Replacement Therapy - a Comparison of Citrate and Heparin Anticoagulation

Conditions
-----------------
Kidney Replacement Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years, acute renal failure with need for continuous veno-venous renal replacement therapy Exclusion Criteria: Age < 18 years, pregnancy, contraindications for one of the two anticoagulation methods, missing informed consent or disagreement in the progress of 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heparin<br>10 Patients undergoing continuous renal replacement therapy using heparin for providing anticoagulation. Blood samples taken at 8 predefined timepoints. | |
| CiCa<br>10 Patients undergoing continuous renal replacement therapy using citrate for providing anticoagulation. Blood samples taken at 8 predefined timepoints. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Filter life time of continuous renal replacement therapy | Filter life time measured in hours of duration of continuos renal replacement therapy, filter life time end, when system clotts. | Individual time point, standardized | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activation of coagulation | blood samples for multiplate, rotem and systemic coagulation paramters | beginning of hemodialysis, 1,2,4,12,24,28,72 hours after start of hemodialysis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
regional and systemical anticoagulation, continuous renal replacement therapy, multiplate, rotational thrombelastometry
Post-Authorization Long-Term Safety Study of LUTATHERA

Study Overview
=================
Brief Summary
-----------------
Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).

Detailed Description
-----------------
To assess the incidence and nature of potential long-term safety outcomes in patients with unresectable or metastatic, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours. Retrospective and prospective data will be used.

Official Title
-----------------
International, Non-interventional, Post-Authorization Long-Term Safety Study of Lutathera, in Patients With Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours

Conditions
-----------------
Neuroendocrine Tumors

Intervention / Treatment
-----------------
* Drug: LUTATHERA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients (fulfilling the definition of age of majority per local regulations), with unresectable or metastatic, well-differentiated, somatostatin receptor positive GEP-NETs and who were treated with Lutathera (regardless of the quantity and number of doses administered and whatever the reasons for ending). Exclusion Criteria: Hypersensitivity to Lutathera (active substance or any of the excipients), presence of established or suspected pregnancy or pregnancy not excluded, presence of kidney failure with creatinine clearance < 30 mL/min.

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 |
| --- | --- |
| LUTATHERA<br>Treated per labeled LUTATHERA dosing regimen. | Drug: LUTATHERA<br>* Labeled dosing regimen: 7.4 gigaBecquerel (GBq) (200 milliCurie [mCi]) every 8 weeks for a total of 4 doses.<br>* Other names: Lu 177 dotatate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary cancers: incidence of secondary cancers | incidence of secondary cancers | up to 7 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety profile: incidence of adverse events | incidence of adverse events | up to 7 years follow-up | 
| mortality | mortality (all cause) | up to 7 years follow-up | 
| LUTATHERA dose per administration | average dose per administration | completion of treatment phase (approximately 2 years total) | 
| LUTATHERA total dose | average total dose administered | completion of treatment phase (approximately 2 years total) | 
| LUTATHERA number of administrations | average number of LUTATHERA doses | completion of treatment phase (approximately 2 years total) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroenteropancreatic neuroendocrine tumours
Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe, Asia, Oceania and the United States of America (USA). This is a one-year clinical trial to compare the safety of inhaled preprandial human insulin to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma.

Detailed Description
-----------------
The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Official Title
-----------------
Inhaled Preprandial Human Insulin With the AERx® iMS Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Asthma: A 52-week, Open-label, Multinational, Randomised, Parallel Trial to Investigate Long-term Safety

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Asthma

Intervention / Treatment
-----------------
* Drug: insulin aspart
* Drug: inhaled human insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or type 2 diabetes Treatment with insulin and/or oral anti-diabetic drugs Asthma for at least 6 months Positive airway reversibility/bronchoprovocation test or documented positive test in the last 3 years HbA1C less than or equal to 11.0 % Body Mass Index (BMI) less than or equal to 40.0 kg/m2 Exclusion Criteria: Current smoking or smoking within the last 6 months Other current acute or chronic pulmonary disease excluding asthma Recurrent severe hypoglycaemia Proliferative retinopathy or maculopathy

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: A<br> | Drug: inhaled human insulin<br>* Treat-to-target dose titration scheme, inhalation.<br>|
| Active Comparator: B<br> | Drug: insulin aspart<br>* Treat-to-target dose titration scheme, injection s.c.<br>* Other names: NovoLog®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in lung function, chest X-rays, or asthma exacerbation frequency |  | after 52 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes control measured by change in HbA1c |  | from baseline to end of treatment | 
| Laboratory assessments (biochemistry, insulin antibodies, blood count) |  | from baseline to end of treatment | 
| Preprandial insulin doses |  | for the duration of the trial |
ANXA5 M2 Haplotyping in IVF Patients and Embryos

Study Overview
=================
Brief Summary
-----------------
This study aims to characterize the association between history of pregnancy complications and M2 carrier status in IVF patients and the utility of M2 haplotype preimplantation genetic testing (PGT) in embryos produced by carrier couples. Participants in this study will be screened for the M2 variant. History of pregnancy complications and miscarriages will be studied in order to determine potential associations with M2 carrier-ship.

Detailed Description
-----------------
Patients consenting to participation in the study will receive a saliva collection kit for M2 testing. Genomic Prediction Clinical Laboratory will perform testing and issue a report per routine clinical procedures. Upon completion of issuing a report, the patients' medical records will be obtained from the IVF Center providing care to the patient. Information obtained may include: history of miscarriage, embryo transfer outcomes, preeclampsia, small for gestation age baby, or thrombophilia disorders. In addition to obtaining records related to history of pregnancy complications, carrier couples will be offered the use of preimplantation genetic testing for M2 carrier status (PGT-M2) in their embryos. Patients electing to perform PGT-M2 will receive PGT-A according to standard clinical practice, along with M2 carrier status. A total of 500 patients will complete the study and may be recruited from any IVF clinic in the United States. Patients will undergo ovarian hyper-stimulation, oocyte retrieval, fertilization and embryo culture per standard clinical protocol determined by each clinic.

Official Title
-----------------
ANXA5 M2 Haplotyping in IVF Patients and Embryos

Conditions
-----------------
Infertility, Miscarriage, Recurrent, Pregnancy Complications

Intervention / Treatment
-----------------
* Other: M2 Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All couples above the age of 18 Exclusion Criteria: Any case where biological parental DNA is unavailable.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infertile patients<br>Patients attending an IVF center for infertility treatment | Other: M2 Test<br>* DNA will be extracted from saliva samples obtained from participants. Genetic testing will be performed to screen for the M2 mutation and determine the carrier status of each patient and partner.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| M2 Haplotype frequency | Frequency of carriers of the M2 haplotype attending an IVF center for infertility treatment. | 1 month |