linjc16/ctgov huggingface dataset:
Intralipid Related Effect on NKcells in Patients With Unexplained Recurrent Spontaneous Abortion

Study Overview
=================
Brief Summary
-----------------
Evaluating the effect of intralipid on the natural killer cells

Detailed Description
-----------------
This study will done on women with recurrent spontaneous abortions having increased NKCELLS activity and evaluate the effect of Intralipid on them after re-estimation of NKcells activity again after one week of Intralipid adminstration

Official Title
-----------------
Intralipid Related Effect on NKcells in Patients With Unexplained Recurrent Spontaneous Abortions

Conditions
-----------------
Recurrent Miscarriage

Intervention / Treatment
-----------------
* Drug: Intralipid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women icluded having recurrent spontaneous abortions equal or more than twice. Alittle women having increased NKCELLS activity. Exclusion Criteria: Any other diseases causing miscarriage as autoimmune (lupus erythematosus or antiphospholipid antibodies syndrome )or endocrinopathy (diabetes mellitus, thyroid disorders and hyperprolactinaemia)or thrombophilia (factor v leiden mutation, protein c or s deficiency, prothrombin G20210A mutation, antithrombin III deficiency ) or abnormal karyotyping to one or both of parents or previous history of hormonal contraception or intrauterine device usage at last 3 months or any contraindications for intralipid usage.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Women with unexplained recurrent spontaneous abortions having increased NKcells activity
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One armed<br>One group of patient will take Intralipid for all | Drug: Intralipid<br>* Adose of intralipid given and rechecking NKcells activity<br>* Other names: Intralipid 18 mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in NK cells activity after injection of intralipid | NK cells is measured before and after injection of intralipid and is noticed for change in activity | One week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intralipid, NK cells, Recurrent miscarriage
Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia (YYFZJDTIHBVRHCIA)

Study Overview
=================
Brief Summary
-----------------
Clinical research of Yang Yin Fu Zheng Jie Du therapy in HBV related hepatocellular carcinoma induced anemia. The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng Jie Du therapy for patients belong to HBV-HCC induced anemia.

Official Title
-----------------
Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia

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

Intervention / Treatment
-----------------
* Drug: Yang Yin Fu Zheng Jie Du therapy
* Other: Routine medical care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the criteria of hepatocellular carcinoma Patients who tested positive for hepatitis B surface antigen (HBsAg) for >6 months Meet the criteria of anemia Ages Eligible for Study: ≤75 years old; Informed consent from the patient. Exclusion Criteria: Patients with upper gastrointestinal bleeding within 3 months before enrollment; History of blood transfusion within 3 months before enrollment; Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD; Serious problem of heart, lung, or kidney with severe dysfunction; Pregnant or child breast feeding women; Mental or cognitive disorders; Participating in other drug trials; Who are allergic to the study drug.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yang Yin Fu Zheng Jie Du therapy<br> | Drug: Yang Yin Fu Zheng Jie Du therapy<br>* Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.<br>Other: Routine medical care<br>* Routine medical care<br>|
| Placebo Comparator: Routine medical care<br> | Other: Routine medical care<br>* Routine medical care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | 1 year | 
| quality of life (QOL) questionnaire | The questionnaire includes appetite, sleep, fatigue, pain, etc. | 1 year |
Phase II/III Study of Anti-VEGF in Neovascular AMD

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether the anti-VEGF drug is effective at stabilizing and/or improving vision in patients with the wet form of AMD

Detailed Description
-----------------
This will be a randomized, double-masked, controlled, dose-ranging, multi-center comparative trial, in parallel groups. Patients will be stratified by clinical center, by percentage of classic CNV vessels: [predominantly classic (>50%) vs. minimally classic (1-49%) vs. purely occult (0%)], and according to whether, or not, they have received prior PDT with Visudyne (no more than once). All patients will be re-randomized after 54 weeks of treatment to either, continue or discontinue therapy for further 48 weeks.

Official Title
-----------------
Phase II/III Randomized, Double-Masked, Trial, to Establish the Safety and Efficacy of Intravitreal Injections of EYE001 (Anti-VEGF Pegylated Aptamer) Given Every 6 Weeks for 54 Weeks, in Patients With Exudative AMD).

Conditions
-----------------
Macular Degeneration, Choroidal Neovascularization

Intervention / Treatment
-----------------
* Drug: EYE001 anti-VEGF aptamer


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients of either gender, aged 50 years or above, diagnosed with subfoveal CNV secondary to AMD and with best corrected visual acuity of 20/40 to 20/320 in the absence of subfoveal atrophy or scarring in the study eye, and better or equal to 20/800 in the fellow eye, may be enrolled. Clinically significant concomitant diseases will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 50 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

| Intervention/Treatment |
| --- |
|Drug: EYE001 anti-VEGF aptamer|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
-----------------
choroidal neovascularization (CNV), subretinal neovascularization
Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial

Study Overview
=================
Brief Summary
-----------------
The present study is a randomized, controlled trial that investigates the effects of parathyroidectomy or medical observation in mild asymptomatic pHPT on morbidity and quality of life (QoL).

Detailed Description
-----------------
The patients are included and randomized by block randomization to medical observation or parathyroidectomy by an experienced parathyroid surgeon. The patients will be followed up for 10 years.

Official Title
-----------------
Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial

Conditions
-----------------
Primary Hyperparathyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Untreated, asymptomatic pHPT 2.60>S-Ca<2.85 mmol/liter Age between 50 and 80 yr No medications interfering with Ca-metabolism Informed consent Exclusion Criteria: Hyperparathyroid bone disease Previous operation in the neck Impaired kidney function Kidney stones Complicating medical conditions Psychiatric disorders Multiple endocrine neoplasia, Familial hypocalcuric hypercalcemia Familial HPT

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
QoL, Osteodensitometry, Arterial pressure, PTH
Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether there is a relationship between serial B-natriuretic peptide (BNP) and implantable device measured intrathoracic impedance in symptomatic and asymptomatic heart failure patients over a 1-year period. Furthermore, this study will establish whether implantable device measured intrathoracic impedance trends with the distance walked on a six-minute hall walk (6MHW), an exercise-based acute measure that has also been associated with heart failure clinical status.

Detailed Description
-----------------
This is a prospective non-randomized longitudinal study. One hundred subjects will participate in 6 monthly and 3 bi-monthly serial assessments of plasma-based BNP, implantable device measured intrathoracic impedance, and clinical evaluation of heart failure status. Each patient will be enrolled in the study for a period of 12 months.

Official Title
-----------------
Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients?

Conditions
-----------------
Congestive Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Baseline BNP > 80 pg/ml Meets current guidelines for ICD implantation with or without CRT Receiving a Medtronic InSync Sentry, Concerto, Virtuoso, or subsequently approved Medtronic ICD with the OptiVol feature. Walk < 450 meters during 6 minute hall walk test Exclusion Criteria: Less than 18 years of age Life expectancy < 6 months History of non-compliance with clinic visits or study-related tasks which may decrease chance of completing of the study Physical disability which limits exercise

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congestive Heart Failure, Implantable Defibrillators, Intrathoracic Impedance
Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on cardiac function in patients undergoing cardiac surgery compared to control intervention.

Detailed Description
-----------------
In detail, we will focus on new onset of atrial fibrillation, ventricular arrhythmias, myocardial injury, and cardiac function. Furthermore, we aim to investigate underlying pathways of RIPC in modifying the perioperative stress response.

Official Title
-----------------
Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery

Conditions
-----------------
Atrial Fibrillation, Ventricular Arrythmias, Myocardial Injury, Cardiac Function

Intervention / Treatment
-----------------
* Procedure: Remote Ischemic Preconditioning
* Procedure: Control/sham procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing heart surgery on cardiopulmonary bypass Exclusion Criteria: Emergency cases Myocardial infarction up to 7 days prior to enrollment Ejection fraction less than 30% Inability to give 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RIPC<br> | Procedure: Remote Ischemic Preconditioning<br>* RIPC will be induced during anesthesia by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 15 mm Hg greater than the systolic arterial pressure measured via the arterial line.<br>|
| Sham Comparator: CONTROL<br> | Procedure: Control/sham procedure<br>* Sham placement of the blood pressure cuff around the upper limb without inflation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New onset of atrial fibrillation |  | Within 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular arrhythmias, myocardial injury, cardiac function. Underlying pathways of Remote Ischemic Preconditioning in modifying the perioperative stress response. |  | Within 24 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ischemic Preconditioning, Cardiac Surgery
Morphofunctional Lung Analysis by Positron Emission Tomography

Study Overview
=================
Brief Summary
-----------------
Patients affected by acute lung injury-acute respiratory distress syndrome (ALI-ARDS) undergo a positron emission tomography (PET) scan in order to analyse lung function.

Official Title
-----------------
Morphofunctional Lung Analysis by Positron Emission Tomography in ALI-ARDS Patients

Conditions
-----------------
Acute Lung Injury, Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ali-ards Age > 18yrs Exclusion Criteria: COPD

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 |
| --- | --- |
| 1: ALI/ARDS<br> | |

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
-----------------
ALI/ARDS
Post-Pregnancy Cardio Trial

Study Overview
=================
Brief Summary
-----------------
Preeclampsia is a systemic pregnancy disorder and is associated with an increased cardiovascular risk later in life. This study will characterize myocardial tissue in patients after preeclampsia compared to controls and investigate potential functional and structural changes in the heart of preeclamptic women primarily with two methods: cardiovascular magnetic resonance imaging and echocardiography. A comparison between these two methods, where appropriate, is also envisaged.

Official Title
-----------------
Myocardial Characterization With Magnetic Resonance Imaging in Patients After Preeclampsia (Pilot Study)

Conditions
-----------------
Preeclampsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postpartal window: 0.5 - 20 years cases: diagnosis of preeclampsia during the index pregnancy controls: age and BMI matched Exclusion Criteria: metal implants kidney insufficiency (GFR < 30 ml/min/) claustrophobia contrast medium allergy current pregnancy/ lactation chronic hypertension (> 140/90) diagnosis of previous cardiovascular disease body weight over 120 kg big tattoos in thorax area

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| PE<br>Women with a history or preeclampsia, between 18 - 50 years of age, 0.5 - 20 years postpartum | |
| Control<br>Age-matched women without any birth complications, between 18 - 50 years of age, 0.5 - 20 years postpartum | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| any structural or functional change of the heart (combined outcome) | Combined outcome: myocardial fibrosis, edema, fat infiltrates, inflammation, reduced ejection fraction, hypertrophy | 0.5 - 20 years after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial fibrosis |  | 0.5 - 20 years after delivery | 
| myocardial edema |  | 0.5 - 20 years after delivery | 
| myocardial fat infiltrates |  | 0.5 - 20 years after delivery | 
| myocardial inflammation |  | 0.5 - 20 years after delivery | 
| myocardial hypertrophy |  | 0.5 - 20 years after delivery | 
| reduced ejection fraction |  | 0.5 - 20 years after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
magnetic resonance imaging, myocard, preeclampsia
Mechano-physiological Approach to Anorectal Function

Study Overview
=================
Brief Summary
-----------------
We hypothesize that defecatory disorders can be described in mechanical terms which would allow a mechanistic description of disorders which would in turn allow better directed biofeedback mechanisms to treat disorders of defecation.

Detailed Description
-----------------
Disorders of defecation are very common and the process of defecation remains poorly described. This results in a limited approach to treatment of patients, with limited success. This study will simultaneously measure multiple components of the process of defecation - the abdominal wall and perineal muscle activity, the pressure within the rectum and in the anal canal and the change in shape of the anorectal region of the colon, in order to develop a biomechanical model which can describe the normal and abnormal defecatory process. It is anticipated that, by understanding the process in these terms will allow a new approach to categorizing and describing defecation problems which in turn will lead to more specific approaches of treatment which will be tailored to individual patients. These parameters will compared in volunteers with no defecatory disorders and patients with defecatory disorders who are being referred for defecography as part of their clinical evaluation.

Official Title
-----------------
Mechano-physiological Approach to Normal Anorectal Function and the Classification of Defecatory Disorders

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Procedure: defecography


Participation Criteria
=================
Eligibility Criteria
-----------------
Controls Inclusion Criteria: Women No defecatory problems On no medication which affect bowel habits Exclusion Criteria: Pregnancy Patients Inclusion Criteria: Difficulty in defecation Women Exclusion criteria: Pregnancy Medication which can affect bowel movement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: defecography|insertion of catheter to record pressure. Insertion of barium to outline rectum and fluoroscopy to define change in rectal contour and expulsion of barium during the study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in shape of anorectum during changes in intraabdominal pressure and defecation | measure change in dimension over time | start of anorectal manometry procedure until procedure end | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Defecography, Pelvic floor dyssynergia, Anismus
Impact of Physiotherapy Intervention for Children With Ankle Sprains

Study Overview
=================
Brief Summary
-----------------
This study will investigate whether adding a physiotherapy intervention to standard Emergency Department care will lead to improved recovery following an ankle sprain in the pediatric and adolescent population as well as to a decrease recurrence of injuries during the year following the initial ankle sprain. Children will be allocated to standard care or to the added intervention group. The study hypothesis is that recovery will be better while recurrence of injury will be less in those receiving the added physiotherapy intervention.

Official Title
-----------------
Exploring the Impact of a Physiotherapy Intervention on the Risk of Re-injury and Recovery in Children and Adolescents With Acute Ankle Sprains: a Randomized Controlled Trial

Conditions
-----------------
Physical Therapy

Intervention / Treatment
-----------------
* Other: Physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 7 to 18 confirmed diagnosis of ankle sprain Ability to Speak French or English Exclusion Criteria: immobilization at the time of ED discharge

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiotherapy intervention<br> | Other: Physiotherapy<br>* Physiotherapy treatment bi-weekly, delivered at the child's home<br>|
| No Intervention: standard care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence of ankle sprain |  | 12 months |