linjc16/ctgov huggingface dataset:
Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing

Study Overview
=================
Brief Summary
-----------------
A randomized, cross-over, open-label study will be conducted to evaluate the equivalency, safety and tolerability of sevelamer once per day dosing, given with the largest meal, compared with standard three times per day dosing, in hemodialysis patients previously using sevelamer. Following a two week Run-In period, a total of 24 patients will be randomized to one of the following treatment sequences: sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals sevelamer dosed three times per day with meals followed by once a day dosing with the largest meal. Patients will maintain a fixed daily dose throughout both treatment periods based on the most recently prescribed sevelamer dose prior to screening.

Official Title
-----------------
A Randomized, Cross-Over Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: Sevelamer hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: life expectancy of at least 12 months, patients have received hemodialysis three times per week for 3 months or longer, patients maintained on sevelamer in a daily dose of ≤ 9,600 mg as their only phosphate binder with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dL (0.97 and 2.10 mmol/L). Exclusion Criteria: active bowel obstruction, dysphagia, swallowing disorders, severe gastrointestinal motility disorders, active ethanol or drug abuse (excluding tobacco), need for antidysrhythmic or antiseizure medications used to control these conditions, poorly controlled diabetes mellitus or hypertension, active vasculitis, active malignancy other than basal-cell carcinoma, HIV infection, any clinically significant unstable medical condition as judged by the investigator.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sevelamer hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment compared on basis of serum phosphorus at end of each treatment and calcium corrected for albumin,calcium-phosphorus product,albumin,iPTH,total,LDL,HDL,non-HDL cholesterol,triglycerides. Safety evaluated on AEs;change in lab values. |  |  |
An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to investigate the safety and efficacy of Optivate®, administered in appropriate dosage to present bleeding and achieve haemostasis in patients with Haemophilia A undergoing surgery.

Official Title
-----------------
An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.

Conditions
-----------------
Haemophilia A

Intervention / Treatment
-----------------
* Biological: Optivate® (Human Coagulation Factor VIII)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Haemophilia A, at least 12 years of age, due to undergo surgery and have a lifetime exposure of at least 20 exposures to a FVIII concentrate. Exclusion Criteria: -

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optivate®<br>Optivate® (Human Coagulation Factor VIII) | Biological: Optivate® (Human Coagulation Factor VIII)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental Recovery for plasma Factor VIII | Incremental recovery is defined as peak rise in plasma Factor VIII levels divided by Factor VIII dose in IU/KG | 90 minutes after pre-operative bolus dose |
Home Program Practice for People With Language Disorders After Stroke

Study Overview
=================
Brief Summary
-----------------
Logbooks are one of the most commonly used methods to both support and track adherence in research studies. This study will look at using logbooks to support adherence to reading practice for individuals with post-stroke aphasia. It is thought that using a logbook will increase practice time.

Official Title
-----------------
Improving Home Program Practice for People With Language Disorders After Stroke

Conditions
-----------------
Aphasia, Stroke

Intervention / Treatment
-----------------
* Behavioral: Logbook


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 6 months post left hemisphere stroke with a diagnosis of aphasia must have self-reported interest in working to improve reading comprehension access to the Internet speak English as a primary language Exclusion Criteria: significant visual or hearing impairment as determined by aphasia-friendly and age-appropriate screening actively receiving speech-language pathology services in which computerized or reading comprehension home practice activities are assigned/requested severe auditory comprehension impairment that limits understanding of one-step directions (i.e., Western Aphasia Battery-Revised sequential commands subtest score below 8).

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: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Single-subject Design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-Subject Design<br>Each participant will go through a baseline phase and then an intervention phase. | Behavioral: Logbook<br>* Participants will record practice in a logbook.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in minutes of practice | The number of minutes practiced | Up to 11 weeks | 
| Change in percentage of adherence to practice goal | The amount of practice compared to the goal | Up to 11 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reading comprehension | As measured by performance on the Reading Comprehension Battery for Aphasia-2 (RCBA-2). A higher score is better. | At first session and at last session time in between up to 5 months |
A Retrospective Study Investigating the Factors Related to Non-tuberculous Mycobacterial Pulmonary Disease in Hong Kong

Study Overview
=================
Brief Summary
-----------------
In this retrospective study, we aim to investigate the demographic and clinical features of patients with nontuberculous mycobacteria (NTM) lung disease in our hospital and the trends and diversity of NTM species isolated in the period of 2009-2018.

Official Title
-----------------
A Retrospective Study Investigating the Factors Related to Non-tuberculous Mycobacterial Pulmonary Disease in Hong Kong

Conditions
-----------------
Non-Tuberculous Mycobacterial Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years old. patients with one or more respiratory isolates (namely, sputum, tracheal aspirates, bronchial washing, bronchial aspirates, bronchial trap and bronchoalveolar lavage) of mycobacteria collected in the Prince of Wales Hospital in the period of 2009-2018. Exclusion Criteria: none

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 |
| --- | --- | --- |
| diversity of nontuberculous mycobacteria species |  | 10 years |
Gene Expression in Patients With Epiretinal Membranes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the expression of selected genes both in epiretinal membranes (ERMs) and peripheral blood mononuclear cells (PBMCs) from patients with primary and secondary epiretinal membranes in proliferative diabetic retinopathy. Possible correlations between messenger ribonucleic acid (mRNA) levels of these genes were also identified.

Official Title
-----------------
Gene Expression and Their Correlations in Patients With Idiopathic and Secondary Epiretinal Membranes in Proliferative Diabetic Retinopathy

Conditions
-----------------
Proliferative Diabetic Retinopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian race, both males and females, aged ≥ 55 years, suffering from idiopathic ERMs or secondary ERMs in proliferative diabetic retinopathy (PDR). Presence of ERM was proven in optical coherence tomography (OCT) examination. Exclusion criteria: aged < 55 years, systemic connective tissue disease, active inflammatory process

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- |
| Idiophatic ERMs<br> | |
| Secondary ERMs<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression in patients with idiopathic and secondary epiretinal membranes in proliferative diabetic retinopathy. |  | The period between the diagnosis of the ERMs and the actual surgery for the condition was between 2 and 43 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
idiopathic epiretinal membranes, secondary epiretinal membranes
Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, international, multicenter study. Patients are randomized to receive either nimodipine or magnesium sulfate. Arm I: Patients receive nimodipine by mouth every 4 hours. Treatment is continued until 24 hours post-partum. Arm II: Patients receive a loading dose of magnesium sulfate IV for 20 minutes, followed by continuous infusion of magnesium sulfate. Treatment is continued until 24 hours post-partum.

Conditions
-----------------
Pre-eclampsia

Intervention / Treatment
-----------------
* Drug: magnesium sulfate
* Drug: nimodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically diagnosed severe preeclampsia at risk for eclamptic convulsions with the following criteria: Blood pressure greater than 160/110 mmHg OR Mean arterial pressure of 126 mmHg Proteinuria greater than 5 g/24 hr Epigastric pain OR Right upper quadrant pain AST/ALT greater than 70 U/L Severe headache and/or scotomata Thrombocytopenia as evidenced by: Platelet count less than 100,000/mm3 Disseminated intravascular coagulation Microangiopathic hemolytic anemia Oliguria (less than 400 mL/day or 30 mL/hr) Pulmonary edema --Prior/Concurrent Therapy-- No prior/concurrent magnesium sulfate or dihydropyridine agents No other concurrent antiseizure medications --Patient Characteristics-- Age: Not specified Performance status: Not specified Hematopoietic: See Disease Characteristics Hepatic: See Disease Characteristics Renal: No severe renal failure See Disease Characteristics Cardiovascular: No history of angina or myocardial infarction No cardiac dysfunction No history or sign of congestive cardiac failure No arrhythmia with ventricular rate less than 60 bpm See Disease Characteristics Pulmonary: See Disease Characteristics --Other:-- No severe mental or physical disorder that may affect therapy Not allergic to drugs with chemical structure similar to nimodipine or magnesium sulfate No evidence of fetal distress or fetal anomalies
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: magnesium sulfate|nan|
|Drug: nimodipine|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
-----------------
cardiovascular and respiratory diseases, hypertensive disorder, pre-eclampsia, rare disease
To Demonstrate the Relative Bioavailability Study of Loratadine 10 mg Tablets

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability study of Loratadine 10 mg tablets.

Official Title
-----------------
Comparative, Randomized, Single-Dose, 3-way Crossover Bioavailability Study of Sandoz Inc. and Schering (Claritin) 10 mg Loratadine Tablets In Healthy Adult Male Volunteers Under Fed and Fasting Conditions

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Drug: Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)
* Drug: Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)
* Drug: Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.) | Drug: Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.)<br> <br> |
| Experimental: 2<br>Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.) | Drug: Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.)<br> <br> |
| Active Comparator: 3<br>Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering) | Drug: Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 54 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antihistamine
Transvaginal Ultrasound Training for Obstetrics and Gynecology Residents

Study Overview
=================
Brief Summary
-----------------
Obstetrics and gynecology residents are deemed to be proficient in transvaginal ultrasound (TVUS) upon graduation from an accredited program, although TVUS education in residency is not standardized. The objective of this study is to assess for improvement in transvaginal ultrasound knowledge among residents after viewing an educational DVD.

Detailed Description
-----------------
This is a multi-site prospective parallel randomized controlled trial using an educational DVD from the American Institute of Ultrasound in Medicine, Gynecology: Beginners Only®, compared to routine education. All participants completed a pretest on transvaginal ultrasound images and principles. The intervention group repeated the test after viewing the DVD. During the trial, performing and logging transvaginal ultrasounds were encouraged. All enrolled residents repeated the test at 6-10 months after intervention.

Official Title
-----------------
Transvaginal Ultrasound Training for the Obstetrics and Gynecology Resident: A Multi-Site Randomized Controlled Trial of Educational DVD

Conditions
-----------------
Ovarian Cysts

Intervention / Treatment
-----------------
* Other: Transvaginal Ultrasound Educational DVD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: resident in obstetrics and gynecology at one of three sites Exclusion Criteria: unable to consent
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Education<br>These residents received their standard residency education and experience. | |
| Experimental: DVD Intervention<br>These residents received a one-hour long DVD lecture in addition to standard residency education and experience. | Other: Transvaginal Ultrasound Educational DVD<br>* American Institute of Ultrasound in Medicine, Gynecology: Beginners Only®<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Pre and Post Study Mean Test Scores |  | 6-10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Pre and Post Viewing Mean Test Scores |  | 1 hour | 
| Difference in Number of Post-Study Logged Transvaginal Ultrasounds |  | Through study completion, an average of 2 years | 
| Mean test score differences in specific question types (images and principles) |  | 6-10 months | 
| Difference in mean scores on orange cards |  | 6-10 months |
Blood Flow Path Reconstruction in Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
89 patients with distal sigmoid and rectal cancer were referred in our observation and underwent MS-CTA between June 2020 and March 2022. We classified the distribution of LCA and confirmed whether there exists AMCA (accessory middle colic artery). Then we planned blood flow path based on the classification of LCA branches before operation. High ligation was applied in regular radical surgery. During operation, we carefully protect the bifurcation of ascending and descending LCA. Then we compared the planned blood flow path with the actual postoperative blood flow path to verify the mechanism we proposed previously.

Official Title
-----------------
Blood Flow Path Reconstruction in Rectal Cancer After High IMA Ligation Through Preoperative and Postoperative Comparison by Manual Subtraction CTA

Conditions
-----------------
Rectal Cancer, Surgery, Image

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) patients with distal sigmoid colon and rectal cancer; (2) cTNM stage was confirmed to be I-III on MRI or CT; (3) Laparoscopic anterior resection (LAR) was performed. Exclusion Criteria: (1) The starting time of arterial phase scanning is earlier； (2) The anatomic structure is not clear; (3) No enhanced CT after operation (only 5 cases).

Ages Eligible for Study
-----------------
Minimum Age: 39 Years
Maximum Age: 81 Years

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six pattens of blood flow and AMCA based on the preoperative observation |  | 1 hour |
Bevacizumab Treatment and Retinal Vessel Monitoring

Study Overview
=================
Brief Summary
-----------------
Bevacizumab might influence the dynamic vessel function after being administered intravenously.

Detailed Description
-----------------
By monitoring different vessel and circulation parameters (e.g. dynamic retinal vessel analyzer) the study will clarify the potential hemodynamic effects of bevacizumab.

Official Title
-----------------
Analysis of Retinal Vessel Reaction and Monitoring of Circulation Parameters During Bevacizumab Therapy

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: bevacizumab treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who wish and need bevacizumab treatment for underlying disease Exclusion Criteria: previous bevacizumab treatment known eye disease, eye surgery or eye trauma in history myopia >-2.0 dpt hyperopia > +2.0 dpt. relevant media opacity of the lens acute heart disease, ischemic insult, proven coronary heart disease cardiac arrhythmia or vessel anomalies seizure disorder or episode in history migraine treatment with corticosteroids within 4 weeks before study inclusion intake of vasoactive drugs like AT-1 or glitazone pregnancy

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 |
| --- | --- |
| TG<br>Bevacizumab treatment group with metastasized cancer | Drug: bevacizumab treatment<br>* single infusion 10 mg/kg<br>* Other names: VEGF-inhibitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diameter of retinal vessels and dynamic vessel reaction |  | Measurements before and after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baroreflex sensitivity, heart frequence variability, reaction to handgrip test |  | Measurements before and after administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bevacizumab, cancer