linjc16/ctgov huggingface dataset:
A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and effectiveness dextroamphetamine to help methamphetamine users quit or cut down on their use. The study lasts for 9 weeks. Eligible participants will attend research visits twice per week, and will receive individual counseling sessions once per week for all 9 weeks. 50% of the participants will receive the active medication while the other 50% will receive the placebo (sugar pill). Neither the participant or the study team will know if the participant is receiving the placebo or active drug.

Official Title
-----------------
A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence

Conditions
-----------------
Methamphetamine Addiction

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-50 yrs. old Exclusion Criteria: pregnant or lactating females Contact site for additional information

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dextroamphetamine<br>Active drug | Drug: Dextroamphetamine<br>* 1 week placebo and 8 weeks 60mg d-AMP QD.<br>|
| Placebo Comparator: Placebo<br>Placebo of drug | Drug: Placebo<br>* 9 weeks of placebo 60mg capsules QD.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects treated with dextroamphetamine will have better outcomes than subjects treated with placebo, as indicated by the number of urine samples that do not indicate new use of MA (the primary outcome measure) |  | Twice per week for 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Addiction, Methamphetamine, Drug Abuse, Drug Treatment, Meth, Treatment for Methamphetamine Dependence
Safe Pregnancy by Infectious Disease Control

Study Overview
=================
Brief Summary
-----------------
Malaria and sexually transmitted infections (STIs) are common in pregnant women in Africa and are important preventable causes of poor birth outcomes and maternal and infant mortality. This study investigated baseline characteristics of the population including: rates of STIs including HIV, prevalence of malaria and tuberculosis (TB) and resistance to common antimalarial drugs.

Detailed Description
-----------------
A cross-sectional observational study was conducted with 2008 pregnant women attending either Binza or Kingasani Maternity clinics in Kinshasa, DRC to determine baseline rates of STIs, TB and malaria. Data was collected for sample size calculation in a larger STI/Malaria and TB randomized controlled trial.

Official Title
-----------------
Safe Pregnancy by Infectious Disease Control in the Democratic Republic of Congo - Pilot Study

Conditions
-----------------
Pregnancy, Malaria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than or equal to 15 years of age pregnant presenting for antenatal care at one of the two target maternities for the first time during the current pregnancy willing to provide informed consent Exclusion Criteria: refusal to participate in the HIV voluntary and counseling program at the maternity center or refusal to share HIV results with the study staff.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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
-----------------
Infectious diseases, Democratic Republic of Congo, Malaria, International, Maternal and child health, Women's Health, Global Network, Sexually transmitted infections (STIs)
Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia

Study Overview
=================
Brief Summary
-----------------
Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia

Detailed Description
-----------------
Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia

Official Title
-----------------
Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia

Conditions
-----------------
Presbyopia

Intervention / Treatment
-----------------
* Drug: BRIMOCHOL™ PF
* Drug: Carbachol PF
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female in good general health Must have presbyopia Exclusion Criteria: History of allergic reaction to the study drug or any of its components Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

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

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

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: BRIMOCHOL™ PF<br>A single drop in each eye at a visit. | Drug: BRIMOCHOL™ PF<br>* A single drop in each eye at a visit.<br>* Other names: carbachol/brimonidine tartrate;|
| Active Comparator: Carbachol PF<br>A single drop in each eye at a visit. | Drug: Carbachol PF<br>* A single drop in each eye at a visit.<br>* Other names: carbachol monotherapy;|
| Placebo Comparator: Vehicle<br>A single drop in each eye at a visit. | Drug: Vehicle<br>* A single drop in each eye at a visit.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in near VA | Percentage of subjects with 3-line improvement in near VA without the loss of at least 1 line in distance VA | Baseline Day 1 |
Pain in Neonates During Screening for Retinopathy of Prematurity Using Two Methods

Study Overview
=================
Brief Summary
-----------------
Retinopathy of prematurity screening is painful. Wide field digital retinal imaging (WFDRI) and binocular indirect ophthalmoscopy (BIO) are being used for screening examinations. The aim of Edinburgh, UK based study is to compare the pain experienced by infants using both examination techniques.

Detailed Description
-----------------
Infants undergoing routine eye screening at Edinburgh Royal Infirmary Neonatal Intensive Care Unit are to be recruited. Infants will be excluded if they require mechanical ventilation or analgesic medication or if they have moderate/severe neurological impairment. The first screening examination for each baby was included. Infants' eyes will be examined by both WFDRI and BIO with eyelid speculum by 2 experienced pediatric ophthalmologists in random order. Observations will be video-recorded during examinations to generate a pain score (premature infant pain profile) for both WFDRI and BIO. The pain scores, heart rates, oxygen saturations and time taken for WFDRI and BIO will be compared using paired t tests.

Official Title
-----------------
Pain in Neonates During Screening for Retinopathy of Prematurity Using Binocular Indirect Ophthalmoscopy and Wide-field Digital Retinal Imaging: a Randomized Comparison

Conditions
-----------------
Retinopathy of Prematurity, Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born at less than 32 weeks gestation and/or birth weight of less than 1500g. Exclusion Criteria: Infants requiring mechanical ventilation Infants requiring analgesic medication Infants with moderate/sever neurological impairment

Ages Eligible for Study
-----------------
Maximum Age: 32 Weeks

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
-----------------
Screening, Retinopathy, Prematurity, Pain
Evaluate a Saw Bone Training Protocol in Using Tactile Sensation to Classify Bone Quality During Implant Surgery

Study Overview
=================
Brief Summary
-----------------
Bone quality is one of the major factors influencing the dental implant survival rate. Bone quality is believed to have effects on initial implant stability and success of osseointegration. Different implant designs and surgical protocols were developed for improving the survival rate in different bone quality. Although bone quality can be partly diagnosed by radiographic images, lots of experienced surgeons also evaluate bone quality with tactile sensation when they drill the bone. However, variations in evaluation of bone density maybe exist among different surgeons. For less experienced dentists, it is difficult to diagnose bone quality with tactile sensation in the beginning. This purpose of this study is to evaluate a training protocol in using tactile sensation to classify bone quality during implant surgery. Saw bones of variant densities are used as training materials. The outcomes before and after training will be compared. The effect of training frequency before surgery will also be evaluated.

Detailed Description
-----------------
Twenty-five dentists will be enrolled into the study. Tests will be performed using visual analog scale to score bone quality of test blocks.

Official Title
-----------------
Evaluate a Saw Bone Training Protocol in Using Tactile Sensation to Classify Bone Quality During Implant Surgery

Conditions
-----------------
Surgery, Training Tactile Sensation, Diagnosis of Bone Quality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Certified dentist with implant surgery experience less than 10 implants. Exclusion Criteria: Age exceed the limits Implant surgery experience more or equal to 10 implants

Ages Eligible for Study
-----------------
Minimum Age: 26 Years
Maximum Age: 40 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on visual analog scale (VAS) score of each test block | Each VAS score performed on the specific test block will be compared between different time point. | 1st time point: test before training & test immediately after training; 2nd time point: 1 week after 1st time point (test after 1 wk); 3rd time point: 1 month after 2nd time point (test after 1month) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental implant,bone quality,tactile sensation
Toxicogenomic and Immunocytotoxic Effects of Propofol and Isoflurane Anesthetics in Patients Undergoing Elective Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if the anesthetics propofol and isoflurane can damage DNA, induce apoptosis, change expression of genes related to apoptosis and DNA repair and change cytokines profile in patients submitted to elective surgery.

Detailed Description
-----------------
It is expected that the results provide relevant information to understand the possible adverse effects of anesthetics and contribute to the establishment of strategies aimed at reducing the risks to exposed individuals.

Official Title
-----------------
Toxicogenomic and Immunocytotoxic Effects of Propofol and Isoflurane Anesthetics in Patients Undergoing Elective Surgery

Conditions
-----------------
Patients in Good Health, Types of General Anesthesia, DNA Damage

Intervention / Treatment
-----------------
* Drug: Comparison of two anesthetic drugs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in good health American Society of Anesthesia status physical I elective minor surgery general anesthesia Exclusion Criteria: smokers alcoholics previous medication or radiation

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br> | Drug: Comparison of two anesthetic drugs<br>* Isoflurane 1,0 minimum alveolar concentration Propofol 2mg/kg and 4ug/ml<br>* Other names: Isoflurane;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of genotoxicity, gene expression, apoptosis and cytokines profile |  | within 1 day after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
isoflurane, propofol, genotoxicity, gene expression, cytokines, apoptosis
An Investigational Study to Test Usability of the Electronic Dosing Equipment Medicpen

Study Overview
=================
Brief Summary
-----------------
This is a study of the electronical dosing tool MedicPen and it's qualities with regards to user friendliness and medication compliance.

Detailed Description
-----------------
The medical device MedicPen will be investigated for it's qualities with regards to medication compliance and user friendliness. The patient group selected here is patients with Crohn's disease that are treated with Azathioprine. The patient selection was made since the metabolite can be easily measured and the compliance can be therefore be followed. The treatment will follow the standard care given to these patients.

Official Title
-----------------
An Investigational Study to Test Usability of the Electronic Dosing Equipment Medicpen During Azathioprine Treatment in Patients With Crohn's Disease or Ulcerative Colitis

Conditions
-----------------
Crohn's Disease, Ulcerative Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years or older Provided written informed consent Diagnosed with Chron's disease or Ulcerative Colitis Treated with Azathiprine for at least 6 months prior to study start Exclusion Criteria: Patients who are, for some reason, judged by the responsible investigator to be unable to handle the device to be tested.

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 |
| --- | --- | --- |
| User friendliness of Dosing Tool MedicPen |  | June 2009 to Nov 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure treatment compliance |  | June 2009 to Nov 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dosing Tool, Compliance, User Friendly, Crohn's Disease, Ulcerative Colitis
Efficacy of Intestinal Decontamination in Patients Colonized by Carbapenem-resistant Klebsiella Pneumoniae and Colistin

Study Overview
=================
Brief Summary
-----------------
The identification of all cases (44 patients) was carried out from the database of microbiology, University Hospital Reina Sofía and the University Hospital of Jerez. For the identification of controls, in case of neutropenic patients, all colonized patients that were included during the study period did not receive any decolonitation treatment; in case of non-neutropenic patients it was studied a paired control by the presence of risk factors that indicated the beginning of decolonitation treatment.

Conditions
-----------------
Patients Colonized by Klebsiella Pneumoniae.

Intervention / Treatment
-----------------
* Drug: Neomycin
* Drug: Streptomycin
* Drug: Gentamicins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with intestinal colonization by Klebsiella pneumoniae, defined as the presence of a positive rectal swab culture at least 7 days prior to initiation of therapy; and patients considered at risk of developing an invasive infection by Klebsiella pneumoniae: Surgery in two weeks Transplant in two weeks Require medical intervention or has a clinical situation that may predispose to the development of a serious infection (chemotherapy, immunosuppression or neutropenia) Recurrent or severe infections Institution admission Fragile patients at high risk of readmission. Exclusion Criteria: The presence of an active infection for Klebsiella Pneumoniae. Concomitant use of systemic antibiotics in the 14 days before the start of decolonization therapy.

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 |
| --- | --- |
| Received therapy desconolizacion against Klebsiella pneumoniae<br> | Drug: Neomycin<br> <br> Drug: Streptomycin<br> <br> Drug: Gentamicins<br> <br> |
| Patients who do not receive the therapy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality for any cause during a six-months period after oral therapy gut decontamination. |  | 6 months |
Gastric Cancer Risk Factors Knowledge in European and Latinamerican Population

Study Overview
=================
Brief Summary
-----------------
This study is divided into two parts: Part 1: An interventional study, with a pre-post study design to determinate the grade of knowledge of established GC risk factors. Part 2: An observational study to know impact on prevalence and infection eradication of H. pylori

Detailed Description
-----------------
Part 1: to determinate the grade of knowledge of established GC risk factors and identification of attitudes about, GC screening programs at baseline, prior to the intervention though an educational program. Part 2: to generate an H. pylori registry, to know its impact on prevalence and infection eradication rate at 6th, 12th, 24th and at Month 36th.

Official Title
-----------------
Interventional Study at the Primary and Secondary Levels of Prevention for Knowledge Regarding GC Risk Factors in EU and CELAC Populations

Conditions
-----------------
Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Part A: Educational Intervention Inclusion criteria Subjects >18 years old, from EU and CELAC countries participating in this study. Has given and signed the IC to participate in this study. Exclusion criteria Subjects who have received some prior preparation (Cancer Gastric Information). Subjects who have previous Knowledge in Gastric Cancer (Example, near relatives who have suffered Gastric Cancer Part B: H. pylori Register Inclusion criteria Subjects ≥18 years old diagnose from H. pylori infection and treated at participant sites Has given and signed the IC. Exclusion criteria Subjects with chronic gastritis without confirmed diagnose of H. pylori infection, pathologically of by urease test. Patient's with CG diagnosis (including gastroesophageal junction cancer).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge GC risk factors and symptoms | Compare the results obtained through a knowledge of CG risk factors by study-specific questionnaire before and after an educational intervention | 3 years | 
| H. pylori prevalence and drug resistance | Generate an H. pylori registry, to know its impact on prevalence and infection eradication rate at months 6th, 12th, 24th and 36th. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric Cancer, Personalized medicine, Oncology, Solid tumor, Primary Intervention