linjc16/ctgov huggingface dataset:
A Pharmacokinetic Study of Cefepime After Administration Into Dialysate in Patients With Continuous Ambulatory Peritoneal Dialysis (CAPD) Peritonitis

Study Overview
=================
Brief Summary
-----------------
Cefepime is a broad-spectrum antibiotic used in treating CAPD peritonitis. However, medical knowledge has been lacking with regard to its pharmacokinetic profile after it has been administered intraperitoneally. The current study aims at determining the drug level at different time after the drug has been added into the peritoneal fluid in patients with CAPD peritonitis. The results of this study will finally leads to rational prescription of this drug at correct dosages.

Official Title
-----------------
Research Study on the Pharmacokinetic Profile of Intraperitoneal Cefepime in Patients With Continuous Ambulatory Peritoneal Dialysis (CAPD) Peritonitis

Conditions
-----------------
Peritonitis

Intervention / Treatment
-----------------
* Drug: Intraperitoneal Cefepime


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years & has been put on CAPD for >= 4 weeks before entering into the study Exclusion Criteria: Known hypersensitivity to cefepime or other cephalosporin; CAPD peritonitis <= 28 days before being enrolled into the study Antibiotic treatment within 1 week prior to entry into the study Severe exit site or tunnel infection on the day of presentation Any conditions that prompt early removal of Tenckhoff catheter irrespective of clinical response to antibiotic treatment Abdominal malignancy; Any surgical causes of peritonitis Suspected or known fungal or tuberculous peritonitis History of dementia or known mental incompetency

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intraperitoneal Cefepime|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
-----------------
CAPD peritonitis, Peritoneal Dialysis, Continuous Ambulatory
A Study To Investigate The Antidepressant Effect Of Lamotrigine In Patients With Bipolar Disorder Using Lithium

Study Overview
=================
Brief Summary
-----------------
This is a study that, in the first 16 weeks, investigates whether lamotrigine versus placebo offers effect on depressive episodes for patients with bipolar disorder (also known as manic depressive disorder) who use lithium. In the following 50 weeks it is investigated whether these patients experience effect on their depressive and/ or (hypo)manic episodes.

Detailed Description
-----------------
A Multicentre, Double-Blind, Randomised, Fixed-Dose Evaluation of the Safety and Efficacy of Lamotrigine (Lamictal®) compared to placebo as add-on therapy to lithium in the Treatment of Bipolar Depression followed by Long-term Prevention of Relapse and Recurrence of Depression and/or Mania in Subjects With Bipolar Disorder

Official Title
-----------------
A Mulitcentre, Double-blind, Randomised, Fixed-dose Evaluation of the Safety and Efficacy of Lamictal (Lamotrigine) Compared to Placebo as an add-on Therapy to Lithium or Another Mood Stabiliser in the Treatment of Bipolar Depression, Followed by Long-term Prevention of Relapse and Recurrence of Depression and/or Mania in Patients With Bipolar Disorder

Conditions
-----------------
Bipolar Disorder, Bipolar Depression

Intervention / Treatment
-----------------
* Drug: lamotrigine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with bipolar disorder (type I or type II) currently suffering from depression that is at least moderate in severity according to a psychiatrist. Currently using lithium. Female subjects can't be pregnant or become pregnant during the study. Exclusion criteria: Actively suicidal. Rapid cyclers. Suffering from significant personality disorders. Alcohol or substance dependent or abusive. Suffering from significant physical conditions.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lamotrigine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on the MADRS depression rating scale at week 8 compared to baseline |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on various mood rating scales and safety measurements at week 16 and between week 16 and week 68 compared to baseline |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bipolar disorder bipolar depression lamotrigine
hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation

Detailed Description
-----------------
Establishment of Clinical Applicable Human Amniotic Epithelial Cell Products and Its Preliminary Application in Allogeneic Hematopoietic Stem Cell Transplantation

Official Title
-----------------
Establishment of Clinical Applicable Human Amniotic Epithelial Cell Products and Its Preliminary Application in Allogeneic Hematopoietic Stem Cell Transplantation

Conditions
-----------------
Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: leukemia patients with allogeneic HSCT KFS score >90 after transplantation, the patient was implanted (peripheral blood neutrophil absolute value >500/ul for 3 consecutive days) no uncontrolled infection after transplantation activity II above aGVHD patients agreed to participate in the study Exclusion Criteria: patients refused to participate in the study patients have poor compliance has received hormone therapy patients had serious heart, lung, liver, kidney and other vital organs damage researchers believe that patients who are not suitable for observation study
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 |
| --- | --- | --- |
| Cell counts of T cells, NK cells, B cells and monocytes | proliferation and apoptosis of T cells, NK cells, B cells and monocytes in peripheral blood of patients | Day 7 |
Prediction of Fluid Responsiveness in Atrial Fibrillation Patients Who Underwent Valvular Heart Surgery: Peep-induced Increase in Central Venous Pressure vs. Passive Leg Raising

Study Overview
=================
Brief Summary
-----------------
Dynamic indices of preload depending on the heart-lung interaction require sinus rhythm and cannot be applied to patients with atrial fibrillation. PEEP-induced increase in central venous pressure (CVP) was shown to be a valid predictor of fluid responsiveness after cardiac surgery in patients with sinus rhythm, and was speculated to be of value in patients with rhythm other than sinus. The aim of this study is to assess the predictability of PEEP-induced increase in CVP and passive leg raising (PLR)-induced changes in stroke volume index (SVI) on fluid responsiveness in patients with atrial fibrillation following valvular heart surgery.

Conditions
-----------------
Valvular Heart Surgery

Intervention / Treatment
-----------------
* Procedure: peep induced CVP
* Procedure: passive leg raising(PLR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥20 atrial fibrillation patients who underwent elective valvular heart surgery Exclusion Criteria: age < 20 LV ejection fraction < 40% any pulmonary disease end stage renal disease high intrabdominal pressure patient contraindication of passive leg raising deep vein thrombosis

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: peep induced CVP<br> | Procedure: peep induced CVP<br> <br> |
| Active Comparator: passive leg raising(PLR)<br> | Procedure: passive leg raising(PLR)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluid responsiveness | ventilator peep setting was adjusted to 0cmH2O as baseline Then peep was increased to 10cmH2O for 5 min. We set peep to baseline 0cmH2O again, making patients to semirecumbent position following passive leg raising at 30 degree for 5 min. After that, 300 ml of hydroxyethyl starch 130/0.4 was infused in the supine position for 10-20 min and haemodynamic variables including SVI were assessed 5 min after completion of fluid challenge. | 1hr after arriving at ICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fluid responsiveness, atrial fibrillation, passive leg raising, central venous pressure, valvular heart surgery
Osteoporosis Disease Management Demonstration Project (0000-037)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the impact of disease management interventions on bone mineral density (BMD) screening rates and osteoporosis treatment rates in women age 65 years or older.

Official Title
-----------------
Osteoporosis Prevention and Treatment Program: A Disease Management Demonstration Project

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Behavioral: Disease Management Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Members of the Henry Ford Health System Exclusion Criteria: Individuals who are not members of the Henry Ford Health System

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 89 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Disease Management Assessment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density (BMD) testing rates |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteoporosis medication treatment rates |  |  |
Cervical Changes by 4h of Hyper-buoyancy Flotation and Followed by 15 Mins 1g Re-loading

Study Overview
=================
Brief Summary
-----------------
Study with the aim to see the effect on a space ground anaologue, Hyperbuoyancy Floatation (HBF) on cervical column.

Detailed Description
-----------------
the aim of the study is to determine the effect of 4h HBF and subsequent passive 1g axial loading upon stature, cervical IVD height) cervical muscle (Longus Collis and Semispinalis Cervicis) thickness and CSA assessed with ultrasound, cervical vertebral compliance, their relationships to induced stature increments and neck pain.

Official Title
-----------------
Cervical Intervertebral Disc Expansion, Vertebral Compliance Reduction and Neck Pain is Induced by 4h of Hyper-buoyancy Flotation That is Only Partially Reversed by 15 Mins 1g Re-loading

Conditions
-----------------
Intervertebral Disc Herniation, Stiffness; Spine

Intervention / Treatment
-----------------
* Device: Hyperbuoyancy Floatation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: physical requirements (1.57-1.90m, 50-95kg) Exclusion Criteria: current back/neck pain, musculoskeletal disorder, cardiovascular disease, spine surgery and being, or suspected to be pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observacional group<br>Subjects must remain to the exposure of gravity (1G) after 4h of hyperbuoyancy floatation(spine unloading) | Device: Hyperbuoyancy Floatation<br>* Subjects are laid supine upon a HBF waterbed encased within a wooden frame partially (50%) filled with water (at 36ºC to maintain thermal comfort) super-saturated with magnesium sulphate. Thus, subjects are buoyant, sinking passively into the bed in proportion to their segmental mass.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height | Standing stature measured by a commercial stadiometer (Seca 217, Germany) | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height of cervical Intervertebral Discs | Disc height (C3-T1) measured by ultrasound (Samsung HS40, South Korea) | up to 2 years | 
| Longus Collis and Semispinalis Cervicis thickness and cross-sectional area. | Neck flexor (Longus Collis) and Neck extensor (Semispinalis Cervicis) were assessed by ultrasound (Samsung HS40, South Korea) and their respective muscle thickness and cross-sectional area was calculated. | up to 2 years | 
| Vertebral Stiffness | Vertebral stiffness from C0 to L5 was assessed passively (in the prone position) with a handheld differential vertebral compliance transducer (PulStar, Sense Technology Inc., USA) in Newtons. | up to 2 years | 
| Self-reported neck pain | Pain rating scale (CHAPS) from 0 to 10 | up to 2 years |
Endocrine Function During Deferasirox Therapy

Study Overview
=================
Brief Summary
-----------------
A national survey on the prevalence and natural history of endocrine complications in thalassemia transfusion--dependent patients treated with deferasirox was designed, in order to assess a larger population during a longer follow up and improve the quality of previous investigations.

Official Title
-----------------
National Survey on Endocrine Function and Bone Metabolism in Transfusion--dependent Patients Treated With Deferasirox

Conditions
-----------------
Iron Overload, Transfusion-dependent Thalassemia, Endocrine; Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult and pediatric patients with transfusion---dependent thalassemia; Chelation with deferasirox as assigned chelation therapy; Available medical history including relevant clinical data (age at start of transfusion regimen, age at start of chelation therapy, prior chelation therapy, concomitant diseases and concomitant treatments, including hormonal replacement treatments if appropriate) and laboratory data (e.g TSH, FT3 and FT4, fasting serum glucose, OGTT serum glucose, bone mineral density z---score, T---score, g/cm2, PTH, FSH, LH, testosterone and estradiol, serum ferritin, liver function tests,renal function tests, MRI T2* value) at baseline and at the end of study Exclusion Criteria: Non transfusion- dependent patients; Other chelation therapy than deferasirox or combination with other chelators during the observation; Absence of complete medical history as above specified

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- | --- |
| Change from baseline number of endocrine disorders at study completion | Absolute change in number of patients diagnosed with any endocrine disorder at the baseline and at the study completion | baseline through study completion, a minimum of 5 years |
NICE Guideline 'Red Flags' to Predict Serious Outcome After Transient Loss of Consciousness

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the accuracy of the National Institute for Health and Clinical Excellence (NICE) guideline 'red flags' to identify patients at high risk of short term serious outcome when presenting in the emergency department (ED) with Transient Loss of Consciousness (TLoC). Red flags were defined as ECG abnormality, history or physical signs of heart failure, TLoC during exercise, family history of sudden cardiac death at an age < 40 years and/or an inherited cardiac condition, new or unexplained breathlessness, heart murmur, absence of prodromal symptoms in any patient aged > 65 years.

Official Title
-----------------
NICE Guideline 'Red Flags' to Predict Serious Outcome After Transient Loss of Consciousness: Prospective Validation Study in the Emergency Department.

Conditions
-----------------
Syncope

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (>= 16 years) with a complaint of TLoC Exclusion Criteria: Patients needing immediate treatment, with trauma related or drug or alcohol related TLoC were excluded, as well as patient with persistent altered level of consciousness, simple fall and drop attack

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| serious outcome | death, myocardial infarction, arrhythmias, pulmonary embolism, stroke or transient ischemic attack, subarachnoid or non traumatic cerebral haemorrhage, aortic dissection, new diagnosis of structural heart disease thought to be related to syncope, and significant haemorraghe or anemia requiring blood transfusion, readmission for similar symptoms related to the initial event and acute intervention during hospital admission | day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serious outcome | death, myocardial infarction, arrhythmias, pulmonary embolism, stroke or transient ischemic attack, subarachnoid or non traumatic cerebral haemorrhage, aortic dissection, new diagnosis of structural heart disease thought to be related to syncope, and significant haemorraghe or anemia requiring blood transfusion, readmission for similar symptoms related to the initial event and acute intervention during hospital admission | 1 year |
Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia

Study Overview
=================
Brief Summary
-----------------
This is a randomized, dose-ranging, efficacy and tolerability study in chronic kidney disease patients with hyperphosphatemia on hemodialysis. Patient participation in the study is approximately 10 weeks in duration.

Detailed Description
-----------------
Hyperphosphatemia is associated with abnormally high blood concentrations of phosphorus. Normally, phosphorus in the body is excreted into urine via the kidneys, but this process is impaired when renal function is reduced. Hyperphosphatemia occurs in many patients with renal insufficiency, especially those on dialysis. High blood phosphorus concentrations trigger various complications caused by phosphorous interaction with blood calcium or parathyroid hormones, and makes patients more prone to calcium deposition in soft tissues such as the coronary arteries, increasing the risk of ischemic heart disease. ILY101 is a non-absorbed, metal-free polymer that binds phosphorus in the gastrointestinal tract, allowing for excretion of phosphorus. It is therefore anticipated to ameliorate hyperphosphatemia by reducing the absorption of phosphorus from the gastrointestinal tract.

Official Title
-----------------
A Phase 2, Randomized, Dose-Ranging, Single-Blind, Efficacy and Tolerability Study of ILY101 in Patients With Chronic Kidney Disease With Hyperphosphatemia on Hemodialysis

Conditions
-----------------
Kidney Diseases, Renal Insufficiency

Intervention / Treatment
-----------------
* Drug: ILY101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CKD patients on dialysis Prior successful use of phosphate binder Signed informed consent Exclusion Criteria: Previous intolerance to polymer-based phosphate binders Kidney transplant planned within 3 months Pregnant or lactating women, or women of child bearing potential not using an acceptable form of birth control Clinically significant liver disease History of bowel obstruction or other significant gastrointestinal disorder Additional study entry criteria will be evaluated during initial screening.

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

| Intervention/Treatment |
| --- |
|Drug: ILY101|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
-----------------
Hyperphosphatemia, Chronic kidney disease, Dialysis, Hyperphosphatemia in CKD patients on dialysis