linjc16/ctgov huggingface dataset:
Assessing Arsenic Trioxide in Young Patients With Leukemia or Lymphoma Who Were Treated on Clinical Trial NCI-00-C-0070J

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying bone marrow and blood samples from patients with leukemia or lymphoma treated with arsenic trioxide may help doctors learn more about cancer. PURPOSE: This research study is assessing arsenic trioxide in young patients with recurrent or refractory leukemia or lymphoma who were treated on clinical trial NCI-00-C-0070J.

Detailed Description
-----------------
OBJECTIVES: To assess the pharmacokinetic and pharmacodynamic profiles of arsenic trioxide in pediatric patients treated on protocol NCI-00-C-0070J. OUTLINE: Bone marrow or peripheral blood mononuclear cells collected during treatment on NCI-00-C-0070J are assessed for pharmacodynamics studies. Plasma cells collected during treatment are assessed for pharmacokinetics studies. Total arsenic (As), inorganic As forms (AsIII and AsV), and methylated metabolites of As are assessed.

Official Title
-----------------
Sample Analysis for Terminated Protocol 00-C-0070, Pediatric Phase I Trial of Arsenic Trioxide

Conditions
-----------------
Lymphoma, Leukemia

Intervention / Treatment
-----------------
* Other: pharmacological study


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed leukemia or lymphoma refractory to standard curative treatment regimens No meningeal leukemia or lymphoma No HIV-related lymphoma No lymphoproliferative diseases Received treatment on protocol NCI-00-C-0070J Bone marrow or peripheral blood and serum samples collected during treatment on NCI-00-C-0070J are available PATIENT CHARACTERISTICS: See NCI-00-C-0070J PRIOR CONCURRENT THERAPY: See NCI-00-C-0070J

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 21 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: pharmacological study|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) |  |  | 
| Pharmacodynamics (PD) |  |  | 
| Correlation of PK and PD with clinical parameters, such as age, gender, and dose |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent childhood acute myeloid leukemia, childhood acute promyelocytic leukemia (M3), recurrent childhood acute lymphoblastic leukemia, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent/refractory childhood Hodgkin lymphoma, childhood chronic myelogenous leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative
Influence of Diet on Pregnancy With Polyhydramnios

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of a diet that is suited for gestational diabetes mellitus on amniotic fluid index in women with idiopathic polyhydramnios.

Official Title
-----------------
The Influence of a Diet Suited for Gestational Diabetes on Amniotic Fluid Index in Patients Diagnosed With Idiopathic Polyhydramnios - a Randomized Controlled Trial

Conditions
-----------------
Polyhydramnios

Intervention / Treatment
-----------------
* Other: Diet as suited for gestational diabetes mellitus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women between 24-37 pregnancy weeks, singleton pregnancy, diagnosed with AFI at 95% or more by gestational age Express their consent to participate in the study and try to make the recommended dietary change for at least two consecutive weeks from the moment the guidelines are given. Without a medical indication for an immediate delivery Exclusion Criteria: Medical recommendation for delivery within two weeks of diagnosis Condition of non-idiopathic amniotic fluid: gestational or pre-gestational diabetes, fetal malformation, proof of fetal infection Premature rupture or membranes Twins pregnancy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Diet<br> | Other: Diet as suited for gestational diabetes mellitus<br>* Diet that consists of complex carbohydrates, and a regimen that includes 6 meals per day, as tailored gor gestational diabetes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amniotic fluid index (AFI) after 2 weeks | AFI as measured in ultrasound | Assess AFI two weeks after diet initiation |
Treatment of Binge Eating Disorder

Study Overview
=================
Brief Summary
-----------------
This is a multicenter (2 sites) randomized trial evaluating three group treatment models for subjects with binge eating disorder. One model is a cognitive behavior treatment (CBT) group, one is partial self help, and one is self help only.

Conditions
-----------------
Bulimia, Obesity

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavior Treatment
* Behavioral: Self Help
* Behavioral: Partial Self Help


Participation Criteria
=================
Eligibility Criteria
-----------------
Meet binge eating disorder (BED) Criteria Not psychotic Not in other treatment

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cognitive Behavior Treatment|nan|
|Behavioral: Self Help|nan|
|Behavioral: Partial Self Help|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
-----------------
Obesity, Binge Eating, Cognitive, Behavior
Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

Study Overview
=================
Brief Summary
-----------------
A prospective open study to determine the efficacy and tolerability of oral linezolid 600mg./day for the treatment of 40 patients with nontuberculous mycobacterial diseases will be conducted at Siriraj Hospital, Mahidol University, Bangkok, Thailand.

Detailed Description
-----------------
This will be an open label clinical study of oral linezolid combination with another oral antimycobacterial drug as the maintenance treatment of nontuberculous mycobacterial diseases in adult. The eligible patients will be treated and monitored for the efficacy and safety every 6 weeks until 6 months then every 3 months for a total duration of 18 months.

Official Title
-----------------
Efficacy and Tolerability of Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

Conditions
-----------------
Non-tuberculous Mycobacterial Infections

Intervention / Treatment
-----------------
* Drug: Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of non-tuberculous mycobacterial (NTM) diseases Active or stable diseases receiving either parenteral or oral antimycobacterial treatment Require at least more than 6 months of treatment from enrollment Exclusion Criteria: Stable NTM diseases with a plan to discontinue treatment within 3 months History of allergy to linezolid Hemoglobin < 7 g/dl) or total white blood count < 3,000 /cu.mm. or thrombocytopenia < 50,000 cells/cu.mm. Concomitant uses of serotoninergic drugs (SSRIs) or Monoamine oxidase inhibitor (MAOIs) within 30 days prior to enrollment Abnormal neurological findings such as numbness, abnormal vision etc.

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
Intervention Model: Single Group Assignment
Interventional Model Description: Open labelled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: treatment<br>oral linezolid tablet 600 mg /day combine with either oral quinolone (ciprofloxacin or levofloxacin) or oral macrolide (azithromycin or clarithromycin) | Drug: Oral Tablet<br>* study drug given and monitored for efficacy and tolerability<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure rate | no symptom and sign of active infection without drug treatment for at least 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of common adverse event (AE) | rate of common AE of linezolid such as thrombocytopenia, optic neuritis and rate of treatment withdrawal due to AEs | 18 months |
Epidemiology of Acute Mesenteric Ischemia

Study Overview
=================
Brief Summary
-----------------
Retrospective population-based study on epidemiology of acute mesenteric ischemia in Estonia Study objective is to describe epidemiologic features in adult patients with acute mesenteric ischemia during years 2016-2020. Patients from all hospitals in Estonia are included.

Official Title
-----------------
Retrospective Population-based Study on Epidemiology of Acute Mesenteric Ischemia in Estonia

Conditions
-----------------
Acute Mesenteric Ischemia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All at least 18-year-old patients with acute mesenteric ischemia during years 2016-2020. Exclusion Criteria: -

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|Descriptive study. No intervention.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence | To identify the incidence of AMI in adult hospitalized patients in Estonia during 2016-2020 | 2016-2020 |
A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
This is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.

Official Title
-----------------
A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vigamox in the Treatment of Bacterial Conjunctivitis

Conditions
-----------------
Acute Bacterial Conjunctivitis

Intervention / Treatment
-----------------
* Drug: Besifloxacin
* Drug: Moxifloxacin solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye. Exclusion Criteria: Pregnant or nursing females. Use of any antibiotic within 72 hours of enrollment. Any disease conditions that could interfere with the safety and efficacy evaluations of the study drug. Participation in an ophthalmic drug or device research study within 30 days prior to entry into this study.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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: Moxifloxacin solution<br>Moxifloxacin hydrochloride ophthalmic solution 0.5% | Drug: Moxifloxacin solution<br>* Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days.<br>|
| Experimental: Besifloxacin Suspension<br>Besifloxacin hydrochloride ophthalmic suspension 0.6% | Drug: Besifloxacin<br>* Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Resolution | Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated) | Day 5(+/- 1 day) | 
| Microbial Eradication | eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated | Day 5 (+/- 1 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Resolution | Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated | Day 8 or Day 9 | 
| Microbial Eradication | Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated | Day 8 or Day 9 |
3D Endoanal Ultrasound and Anal Fistula

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate the use of 3D endoanal ultrasound in preoperative management of anal fistula disease.

Official Title
-----------------
The Role of 3D Endoanal Ultrasound in Management of Anal Fistulas

Conditions
-----------------
Anal Fistula

Intervention / Treatment
-----------------
* Other: 3D endodanal ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anal fistula no previous fistula procedures Exclusion Criteria: previous fistula procedures ano/rectovaginal fistula inflammatory bowel disease more than one internal openings
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anal fistula<br>Patients with anal fistulas, no previous fistula procedures. Ultrasound investigation done as a part of surgical treatment, such as loose seton or fistulotomy. | Other: 3D endodanal ultrasound<br>* Endoanal ultrasound performed with two different transducers preoperatively during a fistula treatment procedure.<br>* Other names: 3D endoanal ultrasonography;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula position | Dorsal? Ventral? Lateral - right or left? | Day 1 | 
| Fistula level | Level I-IV (how much of the sphincter is affected?) | Day 1 | 
| Fistula length | Shorter or longer than 3 cm? | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anal fistula, fistula in ano, endoanal ultrasound, 3D ultrasound, 3D ultrasonography, endoanal ultrasonography, diagnostics
Quality of Life After Open Heart Surgery in Older Patients

Study Overview
=================
Brief Summary
-----------------
Long term follow-up of nonagenarians who have undergone open heart procedures.

Detailed Description
-----------------
Based on population studies, life expectancy at age 80 is 8.5 years, and at the age of 85 years, it is 6.3 years (US Bureau of Census 2000). There are currently 1.6 million nonagenarians and roughly 72,000 centenarians living in the United States. With this increasing elderly population, knowledge of the special management issues and long-term sequela are imperative. Bacchetta and coworkers from our institution presented a 10-year outcomes experience in nonagenarians undergoing cardiac surgery. In 42 consecutive patients, in-hospital mortality was 7%, and 30-day mortality 5%. Postoperative morbidity was documented in 67% with arrhythmias accounting for 31% of the cases, followed by respiratory complications, infections, and strokes. While this is mostly in-hospital data, long-term follow-ups have not been performed.

Official Title
-----------------
Quality of Life After Open Heart Surgery in Older Patients

Conditions
-----------------
Open Heart Surgery Patients

Intervention / Treatment
-----------------
* Procedure: Cardiac Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent open heart procedures and who were 90 years or greater between 1995 and 2004 at The New York Presbyterian Hospital Exclusion Criteria: Patients who refuse follow-up

Ages Eligible for Study
-----------------
Minimum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cardiac Surgery|Coronary artery bypass graft surgery, aortic valve replacement, mitral valve replacement, aortic aneurysm repair|

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
-----------------
nonagenarians, quality of life, cardiothoracic surgery, long term survival
Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to assess the acceptability of home-use mifepristone for termination of pregnancy among women who choose it and their providers. The investigators' secondary aims are to assess rates of follow-up, adherence, efficacy, complications, lost productivity, and to estimate the minimum proportion of women who choose home-use over clinic use of mifepristone.

Official Title
-----------------
Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion

Conditions
-----------------
Termination of Pregnancy

Intervention / Treatment
-----------------
* Drug: Mifepristone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Reproductive age women seeking abortion services. Eligible women will be in general good health and assessed by a clinician to have an intrauterine pregnancy less than 64 days L.M.P on the day mifepristone will be taken. Participants must be eligible for medical abortion according to clinician and clinic standards. In the United States, women only 18 years and older will be eligible to participate, unless the study site obtains a waiver to include minors.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: clinic administration of mifepristone<br> | |
| Experimental: home administration of mifepristone<br> | Drug: Mifepristone<br>* home administration of mifepristone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women who select home-use of mifepristone |  | 1-2 weeks | 
| Satisfaction with Method |  | 1-2 weeks |
Surgical Management of Multiple Mucoepidermoid Carcinoma and Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
A case series of patient having mucoepidermoid carcinoma, had standard treatment protocol and surgeries and followup was performed and the patient postoperative quality of life and recurrent rate was recorded

Detailed Description
-----------------
This case series presents mucoepidermoid carcinoma. Palatal mass was resected with safety margin then immediate opturator inserted; superficial parotidectomy was also done for parotid lesion sparing facial nerve. Post-operative radiotherapy was recommended by pathologist due to evident perineural spread. The patient is tumor free after one year follow-up. Clinical reports about synchronous multiple salivary tumors are very rare, consequently there is little known about its management and clinical presentation. Presence of one or more risk factor should favor expectation of multiple tumors and mandate examination of all salivary tissues. Each tumor should be diagnosed and treated separately according to its nature and extension.

Official Title
-----------------
Surgical Management of Multiple Mucoepidermoid Carcinoma and Adenocarcinoma

Conditions
-----------------
Adenocarcinoma; Mucoepidermoid Carcinoma

Intervention / Treatment
-----------------
* Procedure: resection of mucoeidermoid carcinoma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients suffering from salivary gland tumor Exclusion Criteria: healthy patients with no tumors

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Intervention Model: Single Group Assignment
Interventional Model Description: a case series was performed on 7 patients having mucoepidermoid carcinoma
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Standard resection | Procedure: resection of mucoeidermoid carcinoma<br>* Surgical resection parotid with preservation of facial nerve<br>* Other names: Conservative superficial partoidectomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | in grades the quality of life of patients is assessed by visual analogue scale in a scale from 1-10. higher values indicates better quality of life | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
salivary gland tumor