linjc16/ctgov huggingface dataset:
Monitoring and Evaluation of the Levothyroxin Replacement Therapy in Pregnant Women With Hypothyroidism

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to evaluate the clinical control program in patients with hypothyroidism during pregnancy (suggested in resent guidelines). Is it possible by monitoring the patients every 4. week during pregnancy to keep the thyroid function parameters within the recommended range? A retrospective study of consecutive pregnant women with hypothyroidism followed at the outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012. Patients selected through electronic medical system. Blood tests for the The hormone levels drawn from the laboratory of Clinical Biochemical Department, Herlev Hospital

Official Title
-----------------
Monitoring and Evaluation of the Levothyroxin Replacement Therapy in Pregnant Women

Conditions
-----------------
Hypothyroidism

Intervention / Treatment
-----------------
* Other: biomedical outcomes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive pregnant women with L-T4 treated hypothyroidism followed at the outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| L-T4 treated hypothyroid pregnant women<br>L-T4 treated pregnant women | Other: biomedical outcomes<br>* Evaluation of abnormal blodtests (evaluating thyroid function) from predefined control program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with thyroid function parameters within the intended level |  | nine months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of complications during pregnancy |  | nine months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypothyroidism, pregnancy
The Medacta International AMIStem-P Post-Marketing Surveillance Study

Study Overview
=================
Brief Summary
-----------------
This is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis

Official Title
-----------------
Prospective, Multicentre, Open Study Evaluating the Performance and Stability of the AMIStem-P Femoral Stem

Conditions
-----------------
Arthrosis, Traumatic Arthritis, Rheumatoid Polyarthritis, Congenital Hip Dysplasia, Avascular Necrosis of the Femoral Head

Intervention / Treatment
-----------------
* Device: AMIStem-P


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head, etc.) requiring a total hip replacement Patient eligible to receive an uncemented AMIStem-P femoral stem Patient agreeing to comply with the study requirements Patient willing to provide written informed consent Patient affiliated to a social security system Patients between 18 and 85 years old Exclusion Criteria: Participation in biomedical research Patients younger than 18 years old Vulnerable adult patients according to article L1121-6 of the French Public Health Code Pregnant or breastfeeding women Patients unable to provide written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AMIStem-P|Performance of Total Hip Arthroplasty (THA) with AMIStem-P femoral stem implant|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Kaplan Meier method | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | Harris Hip Score [min = 0 (worst clinical outcome), max = 100 (best clinical outcome)] | 3/6 months, 1, 3, 5 and 10 years | 
| Oxford Hip Score | Oxford Hip Score [min = 0 (worst functional outcome), max = 48 (best functional outcome)] | 3/6 months, 1, 3, 5 and 10 years | 
| Radiographic performance of the implants | Presence of radiolucencies, migration, loosening, subsidence, tilt | 3/6 months, 1, 3, 5 and 10 years | 
| Quality of life - Euroqol questionnaire | EQ-5D-5L score [min = -0.59 (worst functional outcome), max = 1 (best functional outcome)] | 3/6 months, 1, 3, 5 and 10 years | 
| Adverse events | Intraoperative and postoperative adverse events | intraop, 3/6 months, 1, 3, 5 and 10 years |
Clinical Audit on the Managment in Assiut University Children Hospital

Study Overview
=================
Brief Summary
-----------------
clinical audit on the Managment of rheumatic fever in assiut university children hospital.

Detailed Description
-----------------
Acute rheumatic fever,an auto immune response to Group A streptococcus infection of the upper respiratory tract,may result in carditis.when the inflammation leads to permenant damage of the valves the individual has rheumatic heart disease. Recurrences of rheumatic fever are likely in the absence of preventive measures and may cause further cardiac valve and muscle damage,leading to heart failure,stroke and premature death.bacterial endocarditis is also a complication.

Official Title
-----------------
Clinical Audit on the Managment of Rheumatic Fever in Assiut University Children Hospital

Conditions
-----------------
Rheumatic Fever

Intervention / Treatment
-----------------
* Diagnostic Test: C reactive protein, anti streptolysin o antibody test ,erythrocyte sedimentation rate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with confirmed diagnosis of rheumatic fever based on laboratory investigations. Exclusion Criteria: No

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 15 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: C reactive protein, anti streptolysin o antibody test ,erythrocyte sedimentation rate|Throat culture to detect the causative organism|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| laboratory investigations (ASOt , ESR . CRP) | laboratory investigations that measure the inflammation process will be used and the target that the ASOt not increase 1/400 | One year from October 2017 to september 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical measures | improvement of arthritis if found | One year from October 2017 to september 2018 |
Preventive Home Visits for Healthy Pensioners- a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
To investigate whether preventive home visits for healthy persons 75+, made by professional health workers, can change the pattern of care utilization and if the quality of life can improve. The hypothesis is that care utilisation will reduce, mortality decrease and quality of life improve.

Detailed Description
-----------------
To investigate whether preventive home visits for healthy pensioners aged 75 years and over , can change the pattern of care utilization and if the quality of life can improve. To investigate if the results will last after the intervention has come to an end. The concept of care utilization can in this trial be clarified as: use of primary health care use of elderly care including elderly houses mortality use of hospital care The concept of quality of life will in this trial be measured with a number of self judgements. The trial is performed as a randomized controlled trial in a small rural community in the north of Sweden. The staff is professional health workers and the visits is performed in the pensioners own homes.

Official Title
-----------------
Preventive Home Visits for Healthy Pensioners- a Randomized Controlled Trial in Nordmaling

Conditions
-----------------
Prevention, House Calls

Intervention / Treatment
-----------------
* Behavioral: Preventive home visits


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 75 year living in their own home living in Nordmaling, Sweeden Exclusion Criteria: any need of elderly care, long term care or frequent health care

Ages Eligible for Study
-----------------
Minimum 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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Preventive home visits|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use of health care facilities during two years 2000-2001 |  |  | 
| all cause mortality during two years 2000 - 2001 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use of health care facilities 2002-2004 |  |  | 
| all cause mortality during 2002-2004 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly, Preventive home visits
Therapy of Preconditioned Autologous BMMSCs for Patients With Ischemic Heart Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to evaluate the efficacy of the preconditioned autologous bone marrow mesenchymal stem cells for patients with ischemic heart diseases.

Conditions
-----------------
Myocardial Infarction, Acute Myocardial Infarction, Ischemic Cardiomyopathy

Intervention / Treatment
-----------------
* Biological: BMMSCs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age under 75; Clinical diagnosis of acute Myocardial Infarction, chronic Myocardial Infarction and Ischemic Cardiomyopathy NYHA (New York Heart Association) grade: III-IV, LVEF (left ventricular ejection fraction): 25-50%; No infection diseases including HBV (hepatitis B virus), HCV (hepatitis C virus ), syphilis and AIDS; No psychiatric illnesses and speaking dysfunction; Informed consent. Exclusion Criteria: More than 75 years old; LVEF<24%; Unstable hemodynamics, shock; Severe infection; Patients have tumor or other lethal diseases (expectation of life<6 months); Radiation patients; hematopoietic malignancy including Haemophiliacs; Anemia (Hb<100g/L); The other clinical trial participants within one month; Abnormal increasing of the blood biochemical indicators that is not explained by the conditions; Informed refusal.

Ages Eligible for Study
-----------------
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pre-conditioned BMMSCs<br>autologous bone marrow mesenchymal stem cells (BMMSCs) with hypoxia pre-condition and endothelial pre-induction. | Biological: BMMSCs<br> <br> |
| Active Comparator: BMMSCs<br>autologous bone marrow mesenchymal stem cells (BMMSCs) without pre-condition. | Biological: BMMSCs<br> <br> |
| Sham Comparator: Controls<br>standard therapy without autologous bone marrow mesenchymal stem cells (BMMSCs) infusion. | Biological: BMMSCs<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVEF (left ventricular ejection fraction) |  | one year |
Ultrasound Guided Bilateral Superficial Cervical Block for Post-operative Pain Therapy in Thyroid Surgery

Study Overview
=================
Brief Summary
-----------------
Ultrasound Guided Bilateral Superficial Cervical Block for Postoperative Pain Therapy in Thyroid Surgery

Official Title
-----------------
Dexamethasone Effect Using Ultrasound Guided Bilateral Superficial Cervical Block for Postoperative Pain Therapy in Thyroid Surgery

Conditions
-----------------
Bilateral Superficial Cervical Block

Intervention / Treatment
-----------------
* Drug: bupivacaine
* Drug: Dexamethasone
* Device: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) class I and II Exclusion Criteria: allergy to local anesthetics, bleeding diatheses, and local infection or sepsis thyrotoxicosis and , malignancy.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1<br>30 patients will receive bupivacaine | Drug: bupivacaine<br>* group 1<br>Drug: Dexamethasone<br>* group 2<br>Device: ultrasound<br>* in all groups<br>|
| Active Comparator: group 2<br>30 patients will receive bupivacaine and Dexamethasone. . | Drug: bupivacaine<br>* group 1<br>Device: ultrasound<br>* in all groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | visual analoge scale (VAS) | through first 24 h postoperative. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HEART RATE | heart rate( beats per minute) | 5,10,15,30,60,90,120 min introperative | 
| postoperative nausea, vomiting | postoperative nausea, vomiting was recorded | through first 24h postoperative | 
| The time period for the first analgesic requirement | total dose | through first 24h postoperative | 
| blood pressure | blood pressure (mm Hg) | 5,10,15,30,60,90,120 min intraoperative |
IUdR/BUdR Cell Cycle Labelling

Study Overview
=================
Brief Summary
-----------------
To determine cell cycle parameters and changes after treatment, the labelling agent is given and a bone marrow aspiration is accomplished before treatment and after treatment for comparison. Participants must be undergoing concurrent therapy for hematologic malignancy.

Detailed Description
-----------------
Cell cycle parameters include LI, Ts, Tc, T dpot, changes in these parameters, and differences between normal and leukemic cells in patients with hematologic malignancy prior to and following treatment.

Official Title
-----------------
Cell Cycle Kinetics in Vivo in Patients With Hematologic Malignancies Studied by Iododeoxyuridine and Bromodeoxyuridine Labelling

Conditions
-----------------
Hematologic Malignancies

Intervention / Treatment
-----------------
* Drug: Chemotherapy for hematologic malignancy


Participation Criteria
=================
Eligibility Criteria
-----------------
Histologic proof of one of: AML, ALL, or AUL MDS or CMML CML OR undergoing bone marrow transplantation. Participants should be: off therapy for at least two weeks At least 18 years old or older Using adequate contraception if of child-bearing capability.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Chemotherapy for hematologic malignancy|nan|

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
-----------------
G0, Cell Cycle Interphase, G1, G2, S Phase
A Global Imatinib and Nilotinib Pregnancy Exposure Registry

Study Overview
=================
Brief Summary
-----------------
This is a voluntary, international, primarily prospective, observational, exposure-registry and follow-up study of women receiving Imatinib and Nilotinib during pregnancy or within six months prior to pregnancy.

Official Title
-----------------
A Global Imatinib and Nilotinib Pregnancy Exposure Registry A Post-Authorisation Safety Study (PASS)

Conditions
-----------------
All Indications for Glivec/Gleevec and Tasigna

Intervention / Treatment
-----------------
* Drug: Tasigna
* Drug: Gleevec


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide sufficient evidence to confirm that exposure occurred during pregnancy or within 6 months prior to exposure. Be at least 18 years of age Reside in a country supported by the Registry Exclusion Criteria: Cases that do not meet the eligibility criteria are deemed ineligible, including paternal exposures Other protocol-defined inclusion/exclusion criteria may apply
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1 - Pregnancy/Fetal Exposure<br> | Drug: Tasigna<br> <br> Drug: Gleevec<br> <br> |
| Cohort 2 - Interrupted TKI<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitor pregnancies exposed to Imatinib or Nilotinib to estimate prevalence of birth defects |  | During pregnancy or within 6 months prior to conception | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess impact on maternal CML disease when treatment is interrupted |  | During pregnancy or within 6 months prior to conception | 
| Assess post 12 month post-delivery data on maternal and infant status |  | 12 months after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Female, Pregnancy, Hematologic Pregnancy, Complications, Registry, Pregnant Registry, CML, GIST, Gleevec, Tasigna, Glivec, Pregnancy Exposure
Chronic Pain After Scoliosis and Thoracic Surgery in Children

Study Overview
=================
Brief Summary
-----------------
The aim of this epidemiologic prospective study is to determine the prevalence of CPSP defined as pain occurring 4 months after scoliosis and thoracic surgery and rated > 3 on a 10 point visual analogue scale or FLACC scale, in children aged from 6 to 18 years. The main objective : prevalence of chronic post surgical pain 4 months after scoliosis ant thoracic surgery in children aged 6 to 18 years. The secondary objectives: the intensity of chronic post surgical pain, the prevalence of neuropathic syndrome and the predictive risk factors.

Official Title
-----------------
Prevalence of Chronic Pain After Scoliosis and Thoracic Surgery in Children

Conditions
-----------------
Thoracic Surgery, Scoliosis; Adolescence, Pediatric ALL, Chronic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children aged from 6 to 18 years undergoing scoliosis or thoracic surgery in paediatric Bordeaux hospital. Exclusion Criteria: patients who not willing to participate, with children and/or parental insufficient understanding of the questionnaires.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 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 |
| --- | --- | --- |
| pain at 4 months after surgery | visual analogue scale for pain (0_100) | 4 months after scoliosis and thoracic surgery in children aged 6 to 18 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events after surgery | infections, neurologic defect, new surgery, blood hematoma | adverse events during peri-operative period (hospital stay, i.e. during the first month after surgery) | 
| morphine consumption during the perioperative period | morphine consumption (mg/day) | the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization) | 
| pain during the perioperative period | visual analogue scale for pain (0-100) | the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization) | 
| pain during the perioperative period in disabled children aged 6 to 18 years | FLACC scale level (0-100) | the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization) | 
| prevalence of neuropathic syndrome during perioperative period and at 4 months after surgery | DN4 questionnaire | 2'4-48 h hours period after surgery, 4 months after surgery | 
| pain at 4 months after surgery | modified FLACC scale for pain | 4 months after scoliosis and thoracic surgery in disabled children aged 6 to 18 years |