linjc16/ctgov huggingface dataset:
Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia

Study Overview
=================
Brief Summary
-----------------
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the colon can assist clinicians in detecting dysplastic (precancerous) and neoplastic areas. This is a pilot study of a novel technology, a miniaturized microscope device which can be used during standard endoscopy to image the gastrointestinal epithelium. Theoretically, by visualizing superficial mucosal changes at a high-resolution and magnification, the investigators will be able to obtain optical images that can be used to guide endoscopic biopsy and polypectomy. This may foster the selective targeting of dysplasia/neoplasia, thereby improving diagnostic accuracy.

Official Title
-----------------
Evaluation of Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia

Conditions
-----------------
Colon Polyps, Colonic Dysplasia, Anal Dysplasia

Intervention / Treatment
-----------------
* Drug: Proflavine Hemisulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surveillance of polyps or disease of the colon screening colonoscopy anoscopy for suspected or known anal dysplasia or neoplasia Exclusion Criteria: unfit for standard colonoscopy or anoscopy unable to provide informed consent

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

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proflavine Hemisulfate<br> | Drug: Proflavine Hemisulfate<br>* 3-ml of 0.01% proflavine(derived from dissolving 10 mg proflavine hemisulfate USP in 100 ml sterile water)<br>* Other names: Proflavine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine whether tissue in nepoplastic or non-neoplastic |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colon polyps, colonic dysplasia, anal dysplasia, microendoscopy
Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of intranasal FE 992097 in children and adults with Prader-Willi Syndrome.

Conditions
-----------------
Hyperphagia in Prader-Willi Syndrome

Intervention / Treatment
-----------------
* Drug: FE 992097
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 10-18 years of age (both inclusive) Genetically confirmed diagnosis of Prader-Willi Syndrome Determined to be in nutritional phase 3 by clinical assessment based on Miller et al, 2011 Exclusion Criteria: Known genetic, hormonal, or chromosomal cause of cognitive impairment other than Prader-Willi Syndrome Presence of currently active psychotic symptoms Presence of any cardiovascular disorders, epilepsy, frequent migraines or severe asthma Previous diagnosis of autism spectrum disorder by a qualified healthcare provider Prior or concomitant use of a selective serotonin reuptake inhibitor (SSRI) or selective norepinephrine reuptake inhibitor (SNRI), antipsychotic medication, wakefulness-promoting drug, or thyroid hormone unless dosage has been stable ≥6 months at time of screening

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FE 992097<br> | Drug: FE 992097<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total hyperphagia score as measured by a Hyperphagia for Prader-Willi Syndrome Questionnaire |  | from day 1 to day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression - Improvement score |  | at day 15 | 
| Change in Hyperphagia for Prader-Willi Syndrome Questionnaire domain scores |  | from day 1 to day 15 | 
| Change in Children's Yale-Brown Obsessive Compulsive Scale score |  | from screening to day 15 | 
| Change in the food domain of the Reiss Profile |  | from screening to day 15 |
In-Home Use Study to Evaluate Use of an Intimate Health Product in Females

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of an intimate health product on sexual experience in females.

Detailed Description
-----------------
Study to evaluate consumer perceptions of a cosmetic intimate health product on sexual experience in females, using a validated psychometric questionnaire.

Official Title
-----------------
A Single-blind, Multi-center, In-home Use Study to Evaluate Sexual Enhancement Effects of Product PD-F-5394 in Females

Conditions
-----------------
Coitus

Intervention / Treatment
-----------------
* Other: Intimate Health Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal, healthy females >18 years of age In committed heterosexual relationship for >6months Of adequate sexual functioning On acceptable method of birth control Exclusion Criteria: Pregnant or breastfeeding Allergy to product ingredients Irritation or infection in genital area Unstable or uncontrolled medical condition

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

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

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

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

Design Details

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intimate Health Gel | Other: Intimate Health Gel<br>* Intimate Health Gel<br>* Other names: Not marketed yet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of product on sexual enhancement by comparing baseline questionnaire responses to the end of study questionnaire responses |  | End of study (3 weeks after baseline visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product. |  | throughout duration of the study (+ 30 days for spontaneously reported SAEs) |
Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determinate whether in newborns just cleaning the umbilical stump when changing diapers (with water and soap if necessary)is effective in preventing local cord infections and not delaying cord separation as just as cord care alcohol, usually applied in our hospital and suggested to parents at dismission.

Official Title
-----------------
Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord: a Randomized Clinical Trial

Conditions
-----------------
Infection, Skin Diseases, Bacterial, Granuloma

Intervention / Treatment
-----------------
* Behavioral: Hygiene
* Procedure: Usual alcohol care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Appropriate for gestational age newborn Exclusion Criteria: Not appropriate for gestational age newborn

Ages Eligible for Study
-----------------
Maximum Age: 1 Day

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hygiene with water and soap<br> | Behavioral: Hygiene<br> <br> |
| Active Comparator: Usual alcohol care<br> | Procedure: Usual alcohol care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| omphalitis incidence |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| umbilical granuloma incidence |  |  | 
| time to cord separation |  |  |
Non-invasive Measurement of Hemoglobin in Infants and Neonates

Study Overview
=================
Brief Summary
-----------------
Non-invasive measurement of hemoglobin in infants and neonates scheduled for elective congenital heart surgery, weighing between 3kg and 20 kg. SpHb measurement will be compared to the gold standard of hemoglobin measurement - CO-oximetrie - and to the point-of-care (GEM 3500 premiere).

Detailed Description
-----------------
Non-invasive measurement of hemoglobin in infants and neonates scheduled for elective congenital heart surgery, weighing between 3kg and 20 kg. SpHb measurement will be compared to the gold standard of hemoglobin measurement - CO-oximetrie - and to the point-of-care (GEM 3500 premiere). Data collection whenever an arterial blood gas analysis is indicated by the experienced attending anesthetist - before and after cardiopulmonary bypass.

Official Title
-----------------
Non-invasive Measurement of Hemoglobin in Infants and Neonates: Comparison With CO-oximetrie and Point-of-care Devices.

Conditions
-----------------
Hemoglobins

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled for elective congenital heart surgery routine use of an arterial line weight >= 3000g Exclusion Criteria: urgent surgery premature birth parents refuse

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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 |
| --- | --- | --- |
| Hemoglobin measurement non-invasively compared to gold standard hemoglobin |  | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood gas monitoring, non-invasive, hemoglobin
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients with chronic kidney disease who are not on dialysis.

Detailed Description
-----------------
This study will evaluate the efficacy and safety of intravenous (IV) ferumoxytol as compared to oral iron in the treatment of anemia in non-dialysis dependent CKD patients. Patients are randomized to receive either two doses of 510 mg of ferumoxytol within one week or 200 mg oral elemental iron daily for three weeks.

Official Title
-----------------
A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared With Oral Iron) as an Iron Replacement Therapy in Chronic Kidney Disease Patients Not on Dialysis

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: ferumoxytol or oral iron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients ≥ 18 years. Have chronic kidney disease per K/DOQI guidelines. No change in EPO status during study. Baseline hemoglobin of ≤ 11.0 g/dl. Exclusion Criteria: Women who are pregnant or lactating. Received another investigational drug or device within 30 days. Recent parenteral or oral iron therapy. Patients with active GI bleeding or acute bleeding within 4 weeks. Patients that have other causes of anemia. Major surgery within 30 days or anticipated or planned major surgery during the study. Patients whose EPO status changes while on study. Patients with active infections. Recent blood transfusions. Patients with any known allergies to iron products.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ferumoxytol or oral iron|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change in hemoglobin from baseline. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in iron indices. |  |  |
The Validity of the Thai Version of the Confusion Assessment Method

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the validity and reliability of the Thai version of the Confusion Assessment Method for the intensive care (CAM-ICU) in the elderly and the prevalence of delirium in elderly.

Detailed Description
-----------------
The incidence of delirium in intensive care unit varied between 20 and 80% depending on many factors such as types of study, diagnostic tools, severity of patients.The occurrence of delirium is common in elderly patients. However, the prevalence of delirium in the intensive care has not been reported in Thailand. There is no common tool used for detecting delirium in Thai ICU. Currently, CAM-ICU has been developed for nonpsychiatric physician and other health care professionals to detect delirium. The sensitivity and specificity of CAM-ICU was 91-93% and 89-100% respectively. In addition, it has been translated to many version to diagnose deliriums for all over the world. In Thailand, there is no common tool used for detecting delirium in ICU. The use of CAM-ICU may be useful in Thai ICU settings.

Official Title
-----------------
The Validity and Reliability of Thai Version of the Confusion Assessment Method for the Intensive Care Unit (CAM -ICU)

Conditions
-----------------
Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 55 years old Exclusion Criteria: Severe visual or auditory impairment Comatose or moribund patients Unable to communicate with Thai language

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 |
| --- | --- |
| Surgical ICU<br>Patients are admitted to the surgical ICU of Chiang Mai University Hospital within 48 hours . | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity of Thai version of the CAM-ICU for diagnosis of ICU delirium |  | within 48 hours after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of elderly delirium patients in intensive care unit |  | within 48 hours after ICU admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delirium of Mixed Origin, Subacute Delirium, Mental Disorders, Organic, Organic Brain Syndrome, Nonpsychotic, Organic Mental Disorders, Organic Mental Disorders, Psychotic, Psychoses, Traumatic, Cognition Disorder, Confusion state, Disorientation
Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo

Study Overview
=================
Brief Summary
-----------------
Interest of methotrexate in inflammatory rheumatisms was demonstrated since several years. At present time,there is no effective treatment against digital arthritis. The investigators purpose to measure the efficacy of methotrexate on digital arthritis. In this aim, two groups were compared. The first group receive 10mg/week of methotrexate administered in one shot (every Monday for example)during 12 months. The second group receive 10mg/week of placebo according to the same procedure

Official Title
-----------------
Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo - Assessment of Structural and Clinical Action of Magnetic Resonance Imaging

Conditions
-----------------
Polyarthritis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hand arthritis pain over 40/100 stable treatment since 4 weeks at least with non-steroid analgesic between 45 et 85 years Exclusion Criteria: pregnancy or breast feeding women hyaluronic acid injection within the past 6 months cortisonic derivated injection within the past 3 months

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methotrexate<br>Patients with digital arthritis receiving methotrexate treatment at 10mg/week during 12 months | Drug: Methotrexate<br>* Methotrexate: 10mg/week administered in one time, the same day each week (every monday for example)during 12 months<br>|
| Placebo Comparator: Placebo<br>Patients with digital arthritis receiving placebo at 10mg/week during 12 months | Drug: Placebo<br>* Placebo:10mg/week administered in one time, the same day each week (every monday for example)during 12 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain assessed with EVA |  | at screening visit, inclusion visit, first month, and every month during one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life survey : SF-36 |  | at inclusion visit, first month, and every month during one year |
Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy

Study Overview
=================
Brief Summary
-----------------
Purpose: to compare the efficacy of tinidazole and cefazolin on the prophylaxis of the febrile and infectious morbidity after vaginal or abdominal hysterectomy. Methods: A randomized clinical trial carried out at the Women's Integrated Healthcare Center (CAISM)/UNICAMP, Campinas, Brazil. Women undergoing to total vaginal or abdominal hysterectomy were randomly enrolled into one of these three groups of antibiotic prophylaxis: tinidazole, cefazolin or an association of both.

Detailed Description
-----------------
A randomized clinical trial carried out at the Women's Integrated Healthcare Center (CAISM)/UNICAMP, Campinas, Brazil, to compare the efficacy of tinidazole and cefazolin on the prophylaxis of the febrile and infectious morbidity after vaginal or abdominal hysterectomy. Women undergoing to total vaginal or abdominal hysterectomy were randomly enrolled into one of these three groups of antibiotic prophylaxis: tinidazole, cefazolin or an association of both.

Official Title
-----------------
Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy

Conditions
-----------------
Hysterectomy

Intervention / Treatment
-----------------
* Drug: cefazolin
* Drug: tinidazole
* Drug: cefazolin plus tinidazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women undergoing to hysterectomy due to non-oncologic causes Exclusion Criteria: previous pelvic infection antibiotic use within 7 days before surgery study drugs allergy immuno-incompetence urinary tract infection

Ages Eligible for Study
-----------------
Minimum Age: 32 Years
Maximum Age: 72 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cefazolin<br> | Drug: cefazolin<br>* 2.0 g, IV, 2 hours before surgery<br>|
| Active Comparator: tinidazole<br> | Drug: tinidazole<br>* 2.0 g orally, 12 hours before surgery<br>* Other names: imidazoles;|
| Active Comparator: cefazolin plus tinidazole<br> | Drug: cefazolin plus tinidazole<br>* cefazolin, 2.0 g IV 2 hours before surgery plus tinidazole 2.0 g orally 12 hours before surgery<br>* Other names: tinidazole;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative infection |  | one month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hysterectomy, antibiotic prophylaxis, bacterial vaginosis, tinidazole, cefazolin