linjc16/ctgov huggingface dataset:
Thyroid Function and Diabetes Complications

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the potential association between thyroid function and diabetes complications in the elderly subjects with type 2 diabetes mellitus (T2DM).

Detailed Description
-----------------
Aims: We investigated the potential association between thyroid parameters and microalbuminuria in the euthyroid elderly subjects with type 2 diabetes mellitus (T2DM). Subjects: Elderly inhospital patients with T2DM who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2011 to December 2012. Methods: Clinical factors, serum levels of glucose, lipids, free triiodothyronine (FT3), free thyroxine (FT4), thyroid-stimulating hormone (TSH), thyroid autoantibodies,24h urine albuminuria and fluorescence fundus angiography are conducted. The relationships levels of thyroid function and diabetic complications are analysed.

Official Title
-----------------
Association Between Thyroid Function and Diabetes Complications in Elderly Patients With Type 2 Diabetes Mellitus in China

Conditions
-----------------
Diabetes, Thyroid Disease

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are ≥ 60 years old, with T2DM and the diagnostic criteria of T2DM is according to the World Health Organization in 1999. Patients have normal thyroid function and negative for thyroid autoantibodies, such as thyroid peroxidase antibody (TPOAb) or thyroglobulin antibody (TGAb). Exclusion Criteria: Patients with a history of thyroid disease or chronic liver disease or nondiabetic renal problems or cancer. Patients use systemic drug therapy such as thyroxine, anti-thyroid drugs, glucocorticoids and oral contraceptives. Patients are pregnant or lactating women. Patients with acute intercurrent illness of diabetes. Patients with an acute infection. Patients with a history of drug abuse alcohol dependence in the past 5 years.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|This is a cross-sectional study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetic retinopathy which is diagnosed by the measurement of fundus fluorescein angiography. (Diabetic retinopathy is clinically graded based on the international clinical diabetic retinopathy severity scales.) |  | Day One | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24h-albuminuria |  | Day One | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thyroid, Diabetes Mellitus
Energy Expenditure in Weaning From Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
During weaning from mechanical ventilation process, the energy expenditure in T tube is greater than pressure support ventilation.

Detailed Description
-----------------
The energy expenditure (EE) was measured during the two periods of 30-minutes, with the 10 first minutes being discarded for analysis purposes. The other variables were recorded and monitored during the 10th and the 30th minute, in both pressure support (PS) and t-Tube (TT) modes. Patients were randomized in terms of sequence selection: PS - TT or TT - PS. In the baseline period, patients were receiving mechanical ventilation (Servo 900C and Servo 300; Siemens-Elema, Solna, Sweden), with PS ranging from 10 to 15cmH2O. During the PS mode, patients received assisted pressure ventilation of 10 cmH2O, 5 cmH2O of final positive expiratory pressure, the sensitivity of -1cmH2O and FiO2 of 0.4. During TT mode, oxygen flow was delivered in order to keep the same FiO2 that was provided in PS (0.4) as controlled by monitor screen (Datex Ohmeda S/5 - Compact Airway Module, M-COVX model, Finland). In this mode, an extensor was employed, one end of which was connected to the oxygen-enriched and the other end was secured to a 3-output (T) connector, which was attached to the patient's ventilatory prosthesis. During the rest period (30 minutes), patients returned to the mechanical ventilation parameters utilized in the baseline period.

Official Title
-----------------
Energy Expenditure During Weaning From Mechanical Ventilation: Is There Any Difference Between Pressure Support and T-Tube?

Conditions
-----------------
Respiration, Artificial, Energy Metabolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute respiratory failure receiving MV for over 24 hours, in the ICU of the Hospital de Clínicas de Porto Alegre Exclusion Criteria: Patients with chest drainage, hemodynamic instability (characterized by the use of vasoactive drugs), renal failure, mental status change, agitation, sudoresis, tachycardia, axillary temperature above 38°C and inspiratory oxygen fraction (FiO2) over 0.6.

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
-----------------
energy expenditure, mechanical ventilation, weaning, pressure support ventilation, T-tube
Effect of Optic Edge Design in a Silicone Intraocular Lens on Posterior Capsule Opacification

Study Overview
=================
Brief Summary
-----------------
Purpose: To compare the posterior capsule opacification (PCO) inhibiting effect of the sharp posterior optic edge design of the Clariflex silicone intraocular lens (IOL) with that of the double-round edge design of the SI40 (Phacoflex) silicone IOL over a period of 3 years. Setting: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. Methods: Fifty-two patients with bilateral age-related cataract (104 eyes) were included in this randomized, prospective, bilateral, patient- and examiner-masked clinical trial with intra-individual comparison. Each study patient had cataract surgery in both eyes and received an SI40 IOL (anterior and posterior round optic edges) in one eye and a Clariflex IOL with OptiEdge (round anterior and sharp posterior optic edge) in the other eye. Follow-up examinations were at one week, one month, six months, one, two, and three years. Digital retroillumination images were taken of each eye. The amount of PCO was assessed subjectively at the slit-lamp and objectively using automated image analysis software (AQUA) one, two, and three years after surgery.

Conditions
-----------------
Cataract, Pseudophakia

Intervention / Treatment
-----------------
* Device: Cataract surgery with implantation of an intraocular lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bilateral, age related cataract Exclusion Criteria: history of other ocular disease or intraocular surgery diabetes requiring medical control

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cataract surgery with implantation of an intraocular lens|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of posterior capsule opacification (objective and subjective score 0-10) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
posterior capsule opacification, PCO, after cataract, intraocular lens, optic edge design, sharp optic edge
Breast Cancer Tumor Care Observational Programme

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate efficacy and tolerability under anastrozole (Arimidex) treatment.

Official Title
-----------------
Breast Cancer Tumor Care Patient Observation Programme

Conditions
-----------------
Post Menopausal, Arthralgia

Intervention / Treatment
-----------------
* Drug: anastrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women Already on upfront Arimidex Therapy (Start 1-4 weeks before) HR+ Exclusion Criteria: Premenopausal women Tamoxifen switch patients
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | Drug: anastrozole<br>* Oral<br>* Other names: Arimidex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of disease and tolerability in general |  | Baseline, every 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient questionnaire to collect data on Incidence, time of onset and treatment of arthralgia |  | Baseline, every 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arimidex, Post menopausal, arthralgia
Implementation of a Novel Computerized Physician Order Entry System

Study Overview
=================
Brief Summary
-----------------
The objective of this prospective study is to build a real-time interactive platform where doctors and pharmacists may communicate and solve patients' drug-related problems (DRP) immediately and document accordingly. This study will also design a computerized physician order entry (CPOE) system utilizing default protocol for chemotherapy order entry.

Detailed Description
-----------------
To err is human. Most errors are caused by problems in the system. Punishing health personnel cannot prevent the same mistakes. The only solution is a good medication system. CPOE system can prevent prescribing errors. The CPOE system is always the major step in some studies concerning reducing prescribing errors, dispensing errors or administering errors. In this user-friendly and convenient era, improvement in the CPOE system is an immediate need.

Official Title
-----------------
Implementation of a Novel Computerized Physician Order Entry System to Reduce Medication Errors

Conditions
-----------------
Computerized Physician Order Entry

Intervention / Treatment
-----------------
* Behavioral: satisfaction questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NTUH pharmacists Exclusion Criteria: NTUH pharmacists who have never recorded drug related problems

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 65 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 |
| --- | --- |
| Observation<br>Those who will use the new CPOE system | Behavioral: satisfaction questionnaire<br>* Satisfaction questionnaire<br>* Other names: questionnaire;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the timeliness and efficiency of pharmacist's response in DRPs, the average prescription error rate and the satisfaction questionnaire before and after implementation of the new CPOE system. |  | 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medication errors, computerized physician order entry, pharmaceutical care, chemotherapeutic agents, reengineering
Development of Post Traumatic Stress Disorder After Natural Disaster

Study Overview
=================
Brief Summary
-----------------
A survey (patient self-report) of patients presenting to UAB emergency room, outpatient trauma clinics and substance abuse center for symptoms of post-traumatic stress disorder and maladaptive coping responses after the widespread tornado disaster that occurred in Alabama in April 2011.

Official Title
-----------------
Development of Post Traumatic Stress Disorder After Natural Disaster

Conditions
-----------------
Development of PTSD After Natural Disaster

Intervention / Treatment
-----------------
* Other: Referral to counseling services if desired


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 and older Able and willing to complete a questionnaire Exclusion Criteria: Younger than 19 Unwilling or unable to complete a questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| patients in UAB ER,<br> | Other: Referral to counseling services if desired<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of PTSD |  | June 2011-December 2012 |
Reliability for the Detection of Sperm DNA Damage by a Sperm Chromatin Dispersion Test (Halosperm)

Study Overview
=================
Brief Summary
-----------------
It is proposed to measure sperm DNA damage by sperm chromatin dispersion test. This measurement helps to better diagnose male infertility and seems easy to apply in routine. However, the reliability of this method needs to be evaluated before applying for clinical practice in andrology laboratory.

Detailed Description
-----------------
The aim of this study is to measure the inter and intra-observer reliability for the measurements of sperm DNA damage by sperm chromatin dispersion test (halosperm). The gold standard to measure sperm DNA damage is TUNEL (Terminal desoxynucleotidyl end labelling) method. However, this method is not easy to apply in routine. Therefore we investigate to analyse the inter-method reliability between sperm chromatin dispersion test and TUNEL.

Official Title
-----------------
Evaluation of the Reliability for the Measurement of Sperm DNA Damage by a Sperm Chromatin Dispersion Test (Halosperm)

Conditions
-----------------
Infertile Men

Intervention / Treatment
-----------------
* Other: HALOSPERM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertile men <50 years with at least 5.106spermatozoa/ml in the ejacu Exclusion Criteria: azoospermia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: HALOSPERM|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Percentage of spermatozoa with DNA damage (Sperm chromatin dispersion test) |  | at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of sperm DNA damage measured by TUNEL method |  | at day 1 |
Gemcitabine With Curcumin for Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The study hypotheasis is that curcumin, a natural compound with a potent antiproliferative effect, can improve the efficacy of the standard chemotherapy gemcitabine in patients with advanced pancreatic cancer. That is why the patients are given a daily oral dose of 8 gr of curcumin along the chemotherapeutic protocol of weekly gemcitabine.

Official Title
-----------------
Phase II Trial of Gemcitabine and Curcumin in Patients With Advanced Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: curcumin (+ gemcitabine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: locally advanced or metastatic adenocarcinoma of the pancreas no prior chemotherapy performance status 0-2 adequate hematology and chemistry Exclusion Criteria: serious concurrent medical condition

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: curcumin (+ gemcitabine)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to tumor progression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  |  | 
| survival |  |  | 
| clinical benefit |  |  | 
| toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carcinoma, pancreas, gemcitabine, curcumin
The Best Parameter of Bladder Diary Correlates With the Volume at Strong Desire to Void of Filling Cystometry

Study Overview
=================
Brief Summary
-----------------
To identify the bladder diary parameters that are best correlated to VSD.

Detailed Description
-----------------
To identify the bladder diary parameters that are best correlated to VSD.

Official Title
-----------------
The Best Parameter of Bladder Diary Correlates With the Volume at Strong Desire to Void of Filling Cystometry

Conditions
-----------------
Bladder Diary, Urodynamic Studies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients with lower urinary tract symptoms who had underwent urodynamic studies Exclusion Criteria: Patients without data of bladder diary

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Lower urinary tract symptoms<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify the bladder diary parameter that is best correlated to the volume at strong desire to void of filling cystometry. | To identify which bladder diary parameter that is best correlated to the volume at strong desire to void of filling cystometry. Thus, that bladder diary parameter may be used as a surrogate for the volume of strong desire to void of filling cystometry and without the need of urodynamic studies. | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bladder capacity; bladder diary; bladder oversensitivity; lower urinary tract symptoms
Treatment of Patients With Nocturia (Non-PK Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.

Official Title
-----------------
A Phase III Randomized, Double Blind, Placebo Control, Multicenter Study to Investigate the Efficacy the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia (Non PK Study)

Conditions
-----------------
Nocturia

Intervention / Treatment
-----------------
* Drug: SER120
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female 50 years or older Nocturia of 6 or more months duration averaging 2 episodes or more per night Exclusion Criteria: CHF Diabetes Diabetes Insipidus, Renal Insufficiency, Hepatic Insufficiency Incontinence Illness requiring steroids Current or past urologic malignancy Nephrotic Syndrome Unexplained pelvic masses Urinary bladder neurological dysfunction Urinary bladder surgery or radiotherapy Sleep Apnea Pregnant or breast feeding

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SER120<br> | Drug: SER120<br>* Nasal Spray, once a day<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Nasal Spray<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Number of Nocturic Episodes/Night | Change was calculated as the mean number of nocturic episodes per night between baseline and Week 7 | 7 weeks | 
| Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night | Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline | 7 weeks |