linjc16/ctgov huggingface dataset:
Effect of Iron Deficiency Anemia on HBA1C in Patients With Diabetic Foot Ulcer Grade (1and2)

Study Overview
=================
Brief Summary
-----------------
Diabetic foot ulcer is the commonest cause of severe limb ischemia in diabetes mellitus And development of anemia is an additional burden to the microvascular complications of diabetes

Detailed Description
-----------------
HBA1C is the predominant Hemoglobin found in HBA1 fraction and it constitutes 5% of total Hemoglobin in normal adults and up to 15%in patients with diabetes mellitus HBA1C is used to diagnose diabetes and to identify individuals that are at high risk for developing diabetes Iron deficiency anemia is one of the most prevalent form of malnutrition affect 1,62 billion people whish correspond to 24,8%of the world population Ferritin is the storage form of iron so it is found to be test for distinguishing those with iron deficiency anemia from those who are not iron deficient

Official Title
-----------------
Effect of Iron Deficiency Anemia on HBA1C in Patients With Diabetic Foot Ulcer Grade (1and2)

Conditions
-----------------
Iron Deficiency Anemia, HBA1C

Intervention / Treatment
-----------------
* Diagnostic Test: CBC ,Serum ferritin ,HBA1C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all diabetic patients with diabetic foot ulcer grade one and two above 18 year Exclusion Criteria: patients with anemia other than iron deficiency anemia Patients on anticoagulants patients with blood disease 4-patients below 18

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 |
| --- | --- |
| diabetic foot ulcer (1and2)with iron defic<br>50 diabetic patients with diabetic foot ulcer grade (1and2) with iron deficiency anemia will be applied TO cbc ferritin HBA1C ankle brachial index by duplex | Diagnostic Test: CBC ,Serum ferritin ,HBA1C<br>* Diabetic patients will be applied to CBC, HBA1C and serum ferritin<br>* Other names: Ankle brachial index by duplex;|
| diabetic foot ulcer grade(1and2)without iron deficiency anemia<br>50 patients with diabetic foot ulcer grade (1and2) without iron deficiency anemia will be applied to CBC Ferritin, HBA1C ankle brachial index by duplex | Diagnostic Test: CBC ,Serum ferritin ,HBA1C<br>* Diabetic patients will be applied to CBC, HBA1C and serum ferritin<br>* Other names: Ankle brachial index by duplex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron deficiency detected by Hemoglobin level in g/dl HBA1C level in diabetic patients | The influence of iron deficiency anemia on HBA1C in diabetic patients | Base line |
Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.

Official Title
-----------------
A Phase 3, Randomized, Open Label, Safety and Efficacy Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery (STARS J-4 Trial)

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: DU-176b (edoxaban)
* Drug: Enoxaparin sodium 20mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric) Exclusion Criteria: Subjects with risks of hemorrhage Subjects with thrombolic risks Subjects who weigh less than 40 kg Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DU-176b<br>DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery | Drug: DU-176b (edoxaban)<br> <br> |
| Active Comparator: Enoxaparin sodium<br>Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery | Drug: Enoxaparin sodium 20mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Incidence of Major or Clinically Relevant Non-major Bleeding | Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Venous Thromboembolism Events. |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anticoagulants, Enoxaparin sodium, venous thromboembolism., thromboembolism, Thrombosis, deep vein thrombosis, DU-176b, Edoxaban, factor Xa, hip fracture surgery, embolism
Family MobilePhone Otoscopy in Diagnostics of Otitis Media

Study Overview
=================
Brief Summary
-----------------
This is a one-center clinical study carried out in Turku, Finland. The study patients will be randomly allocated to one of the two parallel study groups (teaching group and control group). The hypothesis is that the diagnostic quality of tympanic membrane imagines is better when parents have been taught to conduct middle ear examination with a cellphone otoscope (CellScopeOTO) as compared to no teaching. Furthermore, this study aims at evaluating the diagnostic feasibility of cellphone otoscopy.

Official Title
-----------------
Family MobilePhone Otoscopy in Diagnostics of Otitis Media. (Family mOTO-Study)

Conditions
-----------------
Otitis Media

Intervention / Treatment
-----------------
* Other: Teaching
* Device: (CellScopeOTO)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6 - 35 mo Parents have iPhone 5, 5s or 6 Child is in daycare Child has had at least one acute otitis media within 90 days preceding the enrollment Family agrees to give a mortgage of 40 euros from the CellScopeOTO Exclusion Criteria: Tympastonomy tube present in tympanic membrane Chronic perforation of the tympanic membrane Condition of head/neck anomaly to affect middle ear or ear canal anatomy One child from the family already participating

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 35 Months

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Teaching group<br>Parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals at the first study visit. | Other: Teaching<br> <br> Device: (CellScopeOTO)<br> <br> |
| Other: Control group<br>Families receive the cellphone otoscope as if they had bought it themselves from the internet. After the first study week, parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals. | Device: (CellScopeOTO)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic quality of tympanic membrane imagines | diagnostic quality of tympanic membrane imagines obtained by parents with cellphone otoscope | first study week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
otoscopy, otitis media, cellphone, family
MIST3: Active Patient Safety Reporting

Study Overview
=================
Brief Summary
-----------------
This study will seek to describe and understand adverse events (AE) severity ratings.

Detailed Description
-----------------
Using an explanatory mixed methods design, three different quantitative methods 1. severity ratings based on a series of questions, 2. severity rating based on severity terms, and 3. severity based on definitions will be used to conduct a feasibility study on understanding adverse event reporting system.

Official Title
-----------------
Mitigation Investigation for Spinal Manipulation Treatments (MIST) - Part 3: Continued Assessment & Feasibility of an Electronic Active Surveillance Reporting System

Conditions
-----------------
Safety Issues

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health patients Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Pre-screening questionnaire | Severity rating based on a series of questionnaire | 5-10 minute | 
| Post-survey | Severity rating based on severity term questionnaire | Immediately after visit | 
| follow-up questionnaire | Severity rating based on definitions questionnaire | 7-10 days after visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adverse event, Electronic reporting system, Chiropractic, Spinal manipulation
Working Memory Training in Children With Cerebral Palsy, a Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to assist the preparation of a larger multi-center study. The main aim is to determine the feasibility of conducting computerized working memory training in a group of children with cerebral palsy.

Official Title
-----------------
Computer Based Working Memory Training in Children With Cerebral Palsy, a Pilot Study

Conditions
-----------------
Cerebral Palsy, Working Memory Training

Intervention / Treatment
-----------------
* Behavioral: Cogmed Robomemo working memory training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born at term with unilateral spastic CP Born preterm with bilateral spastic CP Exclusion Criteria: Children with Gross Motor Function Classification Scale (GMFCS) level V Severe visual or hearing impairments Photosensitive epilepsy

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 8 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cogmed Robomemo working memory training<br>Participants will complete 25 sessions (5 weeks) of Cogmed Robomemo (Pearson assessment) working memory training | Behavioral: Cogmed Robomemo working memory training<br>* The Cogmed Robomemo program is designed as a computer game in which an animated robot gives different tasks to be solved by the child. The tasks have various degrees of difficulty adapted continuously throughout the intervention period to the performance of the individual child. The program is standardized in that each child receives the same set of tasks during the training period. The child will perform the training sessions at home using their own computer for about 35-40 minutes each day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in training index | The training index is based on the user's best results from selected exercises in the program. The Start Index is calculated with the results from days 2 and 3, and the Max Index is calculated with the results from the two best days during the training period. The Index Improvement is calculated by subtracting the Start Index from the Max Index. | Changes in training index is measured during 5 weeks of working memory training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological testing |  | baseline and 2 months |
HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies

Study Overview
=================
Brief Summary
-----------------
This study aims at evaluating the safety of an approach based on HLA-mismatched Microtransplantation without immunosuppressive treatment in patients With myeloid hemopathies who are ineligible to conventional allograft

Official Title
-----------------
HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies

Conditions
-----------------
Acute Myeloid Leukemia, Myelodysplastic Syndromes

Intervention / Treatment
-----------------
* Biological: HLA-mismatched microtransplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> or = 65 years with a myeloid hemopathy in Complete Remission or Complete remission with incomplete hematological recovery or Age<65 years with an ineligibility to allograft (contraindication to conditioning) HLA-partially matched family donors Affiliated to(or beneficiary of) the Social Security Informed consent signed Exclusion Criteria: AML3 Previous Hematopoietic Stem Cell TRansplantation Uncontrolled infection -PS>3 -Other progressive cancer Psychiatric disease Vulnerable person or unable to provide informed consent Emergency Unable to comply with required study follow up

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLA-mismatched microtransplantation<br>HLA-mismatched microtransplantation without immunosuppressive treatment | Biological: HLA-mismatched microtransplantation<br>* 3 administrations of hematopoietic stem cells without immunosupression<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment | Cumulative incidence of acute GVH (grade 1 to 4) | 100 days after transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microtransplantation, Myeloid Hemopathy
The Overall Survival of Patients With Unresectable HCC in Real-life

Study Overview
=================
Brief Summary
-----------------
Liver cancer is the fifth most common cancer and the second most frequent cause of cancer-related death globally. Hepatocellular carcinoma represents about 90% of primary liver cancers and constitutes a major global health problem. The pattern of HCC occurrence shows a significant geographical imbalance, with the highest incidence rates in East Asia (more than 50% of the cases occurring in China). The aim of this study is to investigate the overall survival (OS) of patients diagnosed with unresectable hepatocellular carcinoma under real-world practice conditions in Asia Pacific region.

Official Title
-----------------
The Overall Survival of Patients Diagnosed With Unresectable Hepatocellular Carcinoma Under Real-life Clinical Practice in Asia Pacific Region

Conditions
-----------------
Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of unresectable hepatocellular carcinoma Able to comprehend and provide written informed consent in accordance with institutional guidelines. Exclusion Criteria: Patients not willing to participate and/or give their written informed consent.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| Overall survival | Overall survival (OS) is defined as the time (days) from the date of unresectable HCC diagnosis to the date of death, due to any reason. Patients alive or lost to follow-up at the time of analysis will be censored at their last date of follow-up | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | Progression-free survival (PFS) is defined as the time (days) from the start of treatment to the date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented | Up to 5 years | 
| Time to progression (TTP) | Time to progression (TTP) is defined as the time (days) from the start of treatment to the first documented disease progression | Up to 5 years | 
| Duration of treatment | Duration of treatment, defined by the time interval from the start of treatment to the day of permanent discontinuation of treatment (including death) | Up to 5 years | 
| Frequency and Severity of Adverse Events | Safety will be evaluated by monitoring and recording the grade 3, 4 and 5 adverse events (AE) occurring during and after treatment throughout follow up of patients. | Up to 5 years |
A Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine.

Study Overview
=================
Brief Summary
-----------------
Current treatment for gastroesophageal reflux disease (GERD) confirms an unmet need in patients, based on slow onset of action and an inability to provide 24-hour gastric-acid suppression. Clinical data on AH234844 demonstrates a rapid onset of action, high potency, and prolonged duration of effect. The present study endeavors, in part, to compare lavoltidine to two GERD drugs, NEXIUM and ranitidine.

Detailed Description
-----------------
A three-part study in healthy male volunteers to determine the most effective of four different lavoltidine doses on gastric pH and to compare the most effective dose with NEXIUM (esomeprazole) 40mg for the inhibition of gastric-acid secretion and with ranitidine (300mg/day) for the amount of pharmacodynamic tolerance

Official Title
-----------------
A Randomized, Double-blind, Four Period Cross-over Comparison of the Effect of Two Doses Lavoltidine, Esomeprazole, and Placebo on 24 Hour Gastric pH and Frequency of Heartburn in Symptomatic GERD Subjects Without Esophageal Erosions

Conditions
-----------------
Gastroesophageal Reflux Disease, Reflux, Gastroesophageal

Intervention / Treatment
-----------------
* Drug: AH23844 (lavoltidine)
* Drug: NEXIUM (esomeprazole)
* Drug: ZANTAC (ranitidine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subject must have a Body Mass Index (BMI) from 19-30 kg/m2 Subject does not present with abnormal clinical lab findings Subject is able to tolerate a nasogastric pH electrode. Exclusion criteria: Subject is Helicobacter-positive on a C13 urea breath test Subject has a baseline median 24-hour gastric pH>3 For Part B of the study, subjects are CYP 2C19 poor metabolizers.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AH23844 (lavoltidine)|nan|
|Drug: NEXIUM (esomeprazole)|nan|
|Drug: ZANTAC (ranitidine)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pH over 24hours |  | over 24hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %24 hours pH>4 Median gastric pH Adverse events |  | over 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tolerance, pharmacodynamics, ranitidine, esomeprazole, pharmacokinetics, gastroesophageal reflux disease (GERD), AH23844