linjc16/ctgov huggingface dataset:
Psychiatric Disorders Related to Diabetes Mellitus Type 1 Among Children in Egypt

Study Overview
=================
Brief Summary
-----------------
Type 1 diabetes is the most common endocrine disorder in children and adolescents. It is characterised by a deficiency in insulin synthesis and requires daily insulin injections to manage glucose levels. Therefore, there are numerous medical approaches to its therapy, such as levels of glycosylated haemoglobin (HbA1c) as a marker of glycaemic control during the last 3 months and monitoring of blood glucose levels, influencing the mental health and the quality of life of the patient and family. Hens, the importance of the psychological adjustment to children and adolescents with type 1 diabetes besides insulin injection, adequate diet and regular exercise rises, in order to maintain stable psychological status and functional mental health, and prevent psychological disorders such as anxiety, depression and sleep disorders. Approaching the comorbidity in these children and adolescents starts with the diagnosis and with the health changes in all aspects.

Official Title
-----------------
Psychiatric Disorders Related to Children With Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus Type 1, Adolescents, Psychiatric Disorders

Intervention / Treatment
-----------------
* Behavioral: The Strengths and Difficulties Questionnaire (SDQ) Parent Version Parent : It consists of 25 questionnaires used to screen for behavioral problems in children aged 4-17 years.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both boys and girls aged 6-12 years. Willing of the parents or the caregivers to participate in the study. Duration of type 1 DM of at least 1 year. Exclusion Criteria: Children with intelligence quotient below 70. Children with history of substance use. Children with another medical or neurological conditions.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: The Strengths and Difficulties Questionnaire (SDQ) Parent Version Parent : It consists of 25 questionnaires used to screen for behavioral problems in children aged 4-17 years.|screen by using psychometric scales|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure frequency of sleep problems with diabetes mellitus type 1 |  | through study completion, an average of 1 year | 
| Measures frequency of psychiatric problems with diabetes mellitus type 1 |  | through study completion, an average of 1 year |
Safe and Timely Antithrombotic Removal (STAR) Registry

Study Overview
=================
Brief Summary
-----------------
This registry will capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb for the removal of antithrombotic agents.

Detailed Description
-----------------
The STAR Registry will collect patient-level clinical data on antithrombotic removal with CytoSorb. The decision to use CytoSorb in this clinical setting is based on the clinical rationale of mitigating the high risk of bleeding events that is directly linked to the presence of the antithrombotic agent. This registry is to capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb. Data of retrospective and prospective patients will be included in the registry. Safety will be assessed by collection of (at least possibly) device-related adverse events. Data collection is done up to 30 days post-operation.

Official Title
-----------------
Safe and Timely Antithrombotic Removal (STAR) Registry: International Registry on the Use of CytoSorb for Removal of Antithrombotic Agents in the Acute Hospital Setting

Conditions
-----------------
Hemorrhage, Surgical, Hemorrhage Postoperative, Blood Loss, Surgical, Blood Loss, Postoperative

Intervention / Treatment
-----------------
* Device: CytoSorb


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CytoSorb utilization for antithrombotic removal Informed consent for prospective registry participation Exclusion Criteria: • Use of CytoSorb for purpose other than antithrombotic removal

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

| Intervention/Treatment |
| --- |
|Device: CytoSorb|Sorbent hemoperfusion system|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding complications including requirements for transfusions and other blood products |  | Assessed until postoperative day (POD) 3, date of ICU discharge, or date of death, whatever comes first; on average 3 days |
A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Phase II, Double-Blind, Randomized, Placebo-controlled, Parallel Group Study, Evaluating the Efficacy and Safety of RO4607381 Over a 24-week Period in Patients With CHD or a CHD Risk Equivalent

Conditions
-----------------
Coronary Heart Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-75 years of age; CHD or CHD risk equivalent; body weight <125kg at visit 1. Exclusion Criteria: recent (within 3 weeks of screening) clinically significant coronary events; history of statin-associated myopathy, or intolerance to statin; history of malignancy (except for curatively treated basal cell or squamous cell cancer of the skin) during the 3 years prior to screening; exposure to RO4607381 in past 12 months.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dalcetrapib<br>Dalcetrapib 900mg po daily for 24 weeks | Drug: dalcetrapib<br>* 900mg po daily for 24 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo po daily for 24 weeks | Drug: Placebo<br>* po daily for 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change From Baseline in HDL-C |  | Baseline and Week 24 | 
| Percent Change From Baseline in HDL-C |  | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Mass |  | Baseline and Weeks 24 | 
| Change in Mesenteric Lymph Nodes |  | Baseline and 48 Weeks | 
| Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB) |  | Baseline and 48 Weeks | 
| Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Activity |  | Baseline and 48 Weeks |
Rotator Cuff Injury Managed With ERAS and Internet Plus Nursing

Study Overview
=================
Brief Summary
-----------------
Rotator cuff injury patients treated with ERAS were included. The control group was given routine nursing. The observation group was given the Internet plus nursing home rehabilitation mode. Relying on mobile app and wechat, patients can get online guidance of rehabilitation training video through app and wechat, and get professional rehabilitation guidance at any time.

Official Title
-----------------
Rotator Cuff Injury Managed With ERAS and Internet Plus Nursing

Conditions
-----------------
Rotator Cuff Injuries

Intervention / Treatment
-----------------
* Behavioral: Internet plus nursing home rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rotator cuff injury ERAS surgery treatment Full thickness tear of rotator cuff, The range of tear is 1cm-3cm Exclusion Criteria: Surgery not applicable Combined with other injuries, malignant tumor, disabilities, mental illness, critically ill patients, pregnant women, illiteracy, minors, cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>The control group was given routine nursing. | |
| Experimental: Observation group<br>The observation group was given the Internet plus nursing home rehabilitation mode. | Behavioral: Internet plus nursing home rehabilitation<br>* The observation group was given the Internet plus nursing home rehabilitation mode. Relying on mobile app and wechat public service platform, patients can get online guidance of rehabilitation training video through app and wechat, and get professional rehabilitation guidance at any time.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Constant-Murley score | The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The best situation is 100 points. The worst situation is 0 points. | up to 6 months |
Health and Wellness in Obesity

Study Overview
=================
Brief Summary
-----------------
The present study aims to explore the effects of a novel multidisciplinary non-pharmacological intervention designed to improve health parameters and well-being in overweight and obese women. The proposed program is health- and quality of life-oriented, without a focus on weight loss, following the philosophical principles from Health at Every Size, and may provide an alternative mode of intervention to the traditional one, which is focused on the concept of weight loss at any cost. To evaluate the efficacy of the intervention, a mixed-method design combining both qualitative and quantitative assessments will be applied.

Official Title
-----------------
Health and Wellness in Obesity: Exploring the Efficacy of a New Multidisciplinary Intervention

Conditions
-----------------
Obesity, Overweight

Intervention / Treatment
-----------------
* Other: multidisciplinary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: overweight (BMI > 25 kg/m²) without using anti-obesity drugs not engaged in other interventions to control weight Exclusion Criteria: BMI < 25 kg/m² under pharmacological treatment under any type of intervention to control weight inability to exercise
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multidisciplinary intervention<br> | Other: multidisciplinary intervention<br>* a health- and quality of life-oriented program comprising exercise, nutrition advices, and philosophy meetings, without a focus on weight loss, following the philosophical principles from Health at Every Size.<br>|
| No Intervention: control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | will be assessed by quantitative and qualitative research methods | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical capacity | will be assessed by an incremental maximal test | 12 months | 
| body composition |  | 12 months | 
| food pattern and intake | will be assessed by quantitative and qualitative research methods | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overweight, exercise, nutrition, philosophy
Phrenic Nerve Injury During Pulmonary Vein Isolation With the Second-generation Cryoballoon.

Study Overview
=================
Brief Summary
-----------------
To determine the most frequent complication associated with cryoballoon PVI. The main hypothesis is to explore the incidence of phrenic nerve palsy.

Official Title
-----------------
Phrenic Nerve Injury During Pulmonary Vein Isolation With the Second-generation Cryoballoon: Clinical, Procedural, and Anatomical Characteristics

Conditions
-----------------
Phrenic Nerve Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years or older Cryoballoon PVI Periprocedural phrenic lesion Exclusion Criteria: - Non

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 |
| --- | --- | --- |
| Incidence of phrenic nerve palsy | The overall incidence of phrenic nerve palsy during second and third Generation Cryoballoon based PVI will be evaluated. | 06/2012 until 04/2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictors of phrenic nerve palsy | Predictors for transient and permanent phrenic nerve palsy will be evaluated. For this purpose baseline characteristics (e.g. age, sex, BMI, CHADS-VASc-Score) as well as periprocedural data (e.g. minimal cryoballoon temp., cryoballoon temp. after 30 seconds, time to isolation, PV diameter, use of doublestopp technique and draw back manouever) will be assesseda and predictors will be calculated using adequat statistical techniques. | 06/2012 until 04/2018 | 
| Clinical course of phrenic nerve palsy | The clincial course of phrenic nerve palsy after second and third Generation Cryoballoon based PVI will be evaluated by follow-up appointments according to each centers standard of care. For this purpose follow-up data will be evaluated and the clinical course will be assessed. | 06/2012 until 04/2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary vein isolation, Paroxysmal atrial fibrillation, Persistent atrial fibrillation, Phrenic nerve palsy
SHMT1 Polymorphism in Parkinson's Disease,

Study Overview
=================
Brief Summary
-----------------
Parkinson Disease (PD) is the most common movement disorder and represents the second most common degenerative disease of the central nervous system . SHMT has been shown to be associated with various diseases.

Detailed Description
-----------------
This case -control observational prospective study will conducted on 40 patients with PD.

Official Title
-----------------
Genetic Polymorphisms of Serine Hydroxylmethyl Transferase 1 (SHMT1) in Patients With Parkinson's Disease

Conditions
-----------------
Study the Role of SHMT1 Polymorphism in Parkinson Disease

Intervention / Treatment
-----------------
* Genetic: SHMT1 polymorphism


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age ≥ 50 years. Patients with PD diagnosed according to the United Kingdom Parkinson's Disease Society Brain Bank (UK PDS Brain Bank diagnostic criteria) Exclusion Criteria: Patients with parkinsonian plus syndrome Patients with secondary parkinsonism Patients with other chronic comorbidities (renal, hepatic, and endocrinal disturbances and chronic chest disease.) Past and /or present history of epilepsy. Patients with disturbed conscious level.

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| GROUP 1<br>Group 1 (patients with PD) All participants will be subjected to thorough history taking, full clinical and neurological examination. Diagnosis of PD by using Brain Bank Criteria for diagnosis of Parkinson Disease , assessment of the severity of PD by using PDRS and evaluation of cognitive functions using MMSE. | Genetic: SHMT1 polymorphism<br>* It is to identify the role of SHMT1polymorphism in PD and examine the relationship between it and Severity of PD.<br>|
| Group 2<br>Group 2 (controls) All participants will be subjected to thorough history taking, full clinical and neurological examination. | Genetic: SHMT1 polymorphism<br>* It is to identify the role of SHMT1polymorphism in PD and examine the relationship between it and Severity of PD.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| polymorphism of SHMT1gene |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the role of SHMT1plymorphism in pathogenesis PD |  | one year | 
| Study the relationship of Shmt1 polymorphism to the severity of Parkinson disease |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SHMT1 polymorphism, Parkinson disease
Anastrozole and Letrozole

Study Overview
=================
Brief Summary
-----------------
Aromatase Inhibitors (AI) are effective for secondary prevention of breast cancer and may soon replace tamoxifen as first-line therapy in the treatment of hormone-sensitive breast cancer. However, because these medications produce a marked reduction in serum estrogen levels, this is likely to result in an increased rate of bone loss and risk of developing osteoporosis and fractures in postmenopausal women treated with these agents. Indeed, substantial bone loss has been reported in several large clinical trials of AIs. Osteoporosis drugs are available that could prevent this loss, but they have frequent side effects and are expensive. Thus, treating all women receiving AIs might not be the most appropriate and cost-effective approach. A better approach might be to select women at highest risk of bone loss and only treat them with antiresorptive agents. The proposed pilot study will evaluate women who receive anastrozole or letrozole therapy, are receiving adequate amounts of calcium and vitamin D and have baseline normal or moderately low bone mass in order to determine if early changes in bone turnover markers correlate with bone loss at one year. If data from this pilot protocol support our hypothesis, then we would propose a larger trial to confirm it. The ultimate aim is to predict which women are at higher risk of bone loss and therefore treat them earlier with bone-sparing agents, while those with lower risk could be monitored on conservative therapy.

Official Title
-----------------
Effect Of Anastrozole And Letrozole On Bone Turnover Markers And Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer: A Pilot Study

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women with diagnosis of breast cancer - have not started Arimidex or Femara yet, but will be starting . Exclusion Criteria: History of metastasis History of chronic kidney Liver GI disease Disorders affecting calcium metabolism

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| 644-001<br>Women treated for breast cancer who will be starting Arimidex or Femara | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone density |  | baseline, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone markers |  | baseline, 1 month, 3 month, 6 month, 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, arimidex, femara, bone health