linjc16/ctgov huggingface dataset:
Use of Naltrexone in a Clinical Setting

Study Overview
=================
Brief Summary
-----------------
This 12-week trial will compare individuals receiving naltrexone or placebo plus substance abuse counseling therapy versus those receiving only substance abuse counseling therapy in a rural, nonacademic setting. A followup period of 12 months is included. The effect on service utilization and the cost of the addition of naltrexone to treatment services for alcohol dependence also will be assessed. The study will expand existing research concerning the effectiveness of naltrexone in clinical trials versus a clinical setting.

Official Title
-----------------
Effectiveness of Naltrexone in a Community Setting

Conditions
-----------------
Alcoholism

Intervention / Treatment
-----------------
* Drug: naltrexone (Revia)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets criteria for alcohol dependence (within the past 3 months). Meets criteria for another substance use disorder (except narcotic dependence) but must identify alcohol as the primary substance of abuse. Must be able to provide an informed consent. Consent to random assignment and be willing to commit to possible medication treatment and research follow-up. Must be eligible for treatment at the Dorchester Alcohol and Drug Commission. Exclusion Criteria: Meets criteria for opiate dependence. Clinically significant medical problems such as collagen-vascular disease, cardiovascular, renal, gastrointestinal or endocrine problem that would impair participation or limit medication ingestion. Hepatocellular disease. Women who are pregnant, nursing, or not practicing an effective means of birth control. Currently being prescribed naltrexone. Known sensitivity or allergy to naltrexone.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: naltrexone (Revia)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
QBSAfe: A Novel Approach to Diabetes Management Focused on Quality of Life, Burden of Treatment, Social Integration and Avoidance of Future Events

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to co-develop a toolkit (known as the QBSAfe toolkit) with patients, family caregivers, and clinicians that focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety for patients with diabetes mellitus.

Official Title
-----------------
QBSAfe: A Novel Approach to Diabetes Management Focused on Quality of Life, Burden of Treatment, Social Integration and Avoidance of Future Events

Conditions
-----------------
Diabetes, Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: QBSAfe Toolkit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Existing diagnosis of diabetes mellitus; have an existing appointment with a participating clinician Exclusion Criteria: Do not speak English Severe vision/hearing impairment Unable to give informed consent for any reason

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implementation Arm<br> | Other: QBSAfe Toolkit<br>* The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability - Patients | Patient responses to post-visit questionnaires. | Baseline [Post Clinical Encounter] | 
| Acceptability - Clinicians | Clinician responses to post-visit questionnaires. | Baseline [Post Clinical Encounter] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility 1 | Percentage of participants who completed the study procedures. | Baseline [Post Clinical Encounter] | 
| Feasibility 2 | Percentage of recorded visits in which the QBSAFE toolkit was used assessed by Number of visits QBSAFE was used/Number of recorded visits. | Baseline [Post Clinical Encounter] | 
| Feasibility 3 | Time to recruit 84 subjects across 3 sites. | Baseline [Post Clinical Encounter] |
The Influence of Ageing on Muscle Quality

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to evaluate the influence of the ageing process on muscle quality. Therefore, muscle mass, muscle density and force-velocity characteristics are measured after a 5-yr interval in older adults (65+).

Conditions
-----------------
Ageing Process, Muscle Quality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male, +65 years participation in previous study De effecten van oefenprogramma's op gezondheids- en fitheidsgerelateerde parameters in een groep van 60-plussers able to perform a maximal strength test on a dynamometer Exclusion Criteria: pathologies that prohibit a maximal strength test on a dynamometer

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fitness<br> | |
| Whole-body vibration<br> | |
| Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Long Term Dental Effects in Adolescents Who Were Treated for Cancer in Childhood

Study Overview
=================
Brief Summary
-----------------
The investigators aim is to explore associations between specific types of cancer therapy, age at treatment and the presence of dental abnormalities in adolescence. The study will help identify unique dental changes, malformations and or missing teeth that appear in adolescence as a secondary complication due to anticancer treatment (chemotherapy and or radiotherapy) given in childhood. Materials and methods: Study Group: 200 patients, at least 12 years old, who were treated for Cancer at the age of 0-10 years old. The following data will be collected: Demographic information, Medical Status, Cancer therapy, Intraoral examination, Oral soft and hard tissue condition and radiographic examination.

Official Title
-----------------
Long Term Oral and Dental Effects in Adolescents Who Were Treated for Cancer in Childhood

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

Intervention / Treatment
-----------------
* Other: Collecting data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: were treated for Cancer at the age of 0-10 years old Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 32 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Collecting data|Collecting data from patient records|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral abnormalities associated with cancer therapy. | A medical survey will be filled out with the patient and his legal guardian. A full dental examination will gather all clinical and radiographic findings. The following measures will be noted: Description of chemotherapy agents and duration Radiotherapy continuation. Radiotherapy dosage in Gray units. Yes/No questions regarding previous dental trauma. Yes/No questions regarding previous dental treatment. Questions regarding oral hygiene. Questions concerning oral habits. Extra oral examination. Intra oral clinical findings will be listed by tooth number. Radiographic findings will be listed by tooth number. | Two years |
Postoperative Complications After Appendectomy

Study Overview
=================
Brief Summary
-----------------
The frequency of complications after appendectomy is about 9% . The predictive value of CRP as an indicator of postoperative complications has been addressed in a small number of studies. The aim of the present retrospective analysis was to determine whether postoperative CRP levels are a reliable predictor of postoperative complications.

Detailed Description
-----------------
Background: Acute appendicitis is a common emergency in general surgery. The frequency of complications after appendectomy is about 9% [9]. The predictive value of CRP as an indicator of postoperative complications has been addressed in a small number of studies. The aim of the present retrospective analysis was to determine whether postoperative CRP levels are a reliable predictor of postoperative complications. Methods: This retrospective single-center cohort study comprised 744 patients who had undergone open or laparoscopic appendectomy for clinically suspected appendicitis between 1 January 2011 and 31 December 2015 at the department of general and visceral surgery, Kepler University Hospital in Linz, Austria. Demographic data, the surgical technique, postoperative complications, histopathological findings, postoperative white blood counts, and C-reactive protein levels were evaluated.

Official Title
-----------------
Clinical Value of Postoperative C-reactive Protein in the Detection of Complications After Open and Laparoscopic Appendectomy

Conditions
-----------------
Appendicitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically suspected appendicitis between 1 January 2011 and 31 December 2015 Exclusion Criteria: an elective appendectomy as part of an oncological or gynecological operation tumor was found intraoperatively and required ileocecal resection or right hemicolectomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 96 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| open appendectomy<br>Patients were selected retrospectively on the basis of the documented MEL code (medical service code) of open appendectomy (AE) | |
| laparoscopic appendectomy<br>Patients were selected retrospectively on the basis of the documented MEL code (medical service code) of open laparoscopic appendectomy (LSK AE) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| superficial wound infection | superficial wound infection in open and laparoscopic appendectomy | 4 weeks postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraabdominal abscess | intraabdominal abscess in open and laparoscopic appendectomy | 4 weeks postoperative | 
| ileus | ileus in open and laparoscopic appendectomy | 4 weeks postoperative |
Public Title：A Study on the Registration of The Use of Feilike HeJi in Adults

Study Overview
=================
Brief Summary
-----------------
Feilike HeJi is produced by Guizhou Jianxing Pharmaceutical Co. LTD. For the treatment of phlegm heat caused by lung cough phlegm yellow, bronchial asthma, bronchitis, see the syndrome of proprietary Chinese medicine (approval number: Z20025136) approved by the state and the drug from radix scutellariae, radix peucedani, radix stemonae, red gentian root of deal, phoenix tree, spreading hedyotis herb, red tube 7 flavour, with qingrejiedu, antitussive expectorant effect. In order to fully understand the safety of Feilike HeJi in clinical practice and fulfill the responsibility of production enterprises for patients, the production enterprises initiated this study to further evaluate the safety and understanding of the function characteristics of Feilike HeJi in a wide range of people, so as to guide the clinical rational drug use.

Official Title
-----------------
Scientific Title：A Study on the Registration of The Use of Feilike HeJi in Adults

Conditions
-----------------
Bronchial Asthma

Intervention / Treatment
-----------------
* Other: NO.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients (age ≥18 years old) who use Feilike HeJi at the specified monitoring time and in the monitoring center (department) ; Must voluntarily participate in this study; Must meet ethical requirements. Exclusion Criteria: NO

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 |
| --- | --- |
| experimental group<br> | Other: NO.<br>* NO.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AE | All the data to be collected are included in Table A and Table B of the registration And Research Information collection of Adults using Feilike HeJi.Data in Table A are filled in by authorized researchers (such as clinicians) and patients, and data in Table B are filled in by authorized researchers (such as clinicians). | From the prescription of Feilike HeJi to 3 days after stop using Feilike HeJi. |
RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer receiving oral chemotherapy.

Official Title
-----------------
Prospective Controlled Randomized Comparative Study About Quality of Life (QoL), Immunomodulation and Safety of Adjuvant Mistletoe Treatment in Patients With Gastric Carcinoma Receiving Chemotherapy After Operation

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

Intervention / Treatment
-----------------
* Drug: mistletoe extract
* Drug: doxifluridine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postoperative UICC stage Ib/II gastric carcinoma indication for oral chemotherapy with doxifluridine ECOG performance status 0 or 1 normal liver and kidney function Exclusion Criteria: inability to answer the QoL scales concomitant therapy with steroids or biological response modifiers individual hypersensitivity to mistletoe preparations pregnancy or lactating participation in another clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: doxifluridine<br>oral chemotherapy with the 5-FU prodrug doxifluridine | Drug: doxifluridine<br>* 600 - 900 mg per day orally, depending on weight and status of the patient<br>* Other names: Didox;|
| Experimental: doxifluridine + mistletoe extract<br>oral chemotherapy with the 5-FU prodrug doxifluridine + mistletoe extract as subcutaneous injection | Drug: mistletoe extract<br>* subcutaneous injections thrice weekly with 1 ml in 4 increasing doses<br>* Other names: abnobaVISCUM Quercus 20 mg;Drug: doxifluridine<br>* 600 - 900 mg per day orally, depending on weight and status of the patient<br>* Other names: Didox;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | EORTC Quality of Life Questionnaires: QLQ-C30 QLQ-STO22 | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunomodulation | cytokine levels (TNF-alpha and interleukin-2) lymphocyte subsets (CD 16+/CD56+ and CD 19+) | 24 weeks | 
| Safety and tolerability | differential blood count liver functions tests adverse events | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
QoL, Quality of Life, EORTC QLQ-C30, EORTC QLQ-STO22, 5-FU, Viscum album
Thiopurine Methyltransferase Polymorphisms Evaluation

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the frequency of allelic variants in TPMT in the Hispanic population and to compare the frequency in the Hispanic population with the Caucasian Population.

Detailed Description
-----------------
Relatively few studies have been performed evaluating the variant allele frequencies in Spanish populations. To date, no studies evaluating the TPMT variant allele frequency in the Hispanic population have been reported. Hispanics are a growing part of the patient population treated in the United States. Characterization of the proportion of patients with variant genotypes in this population is important since Hispanic children represent a significant proportion of children being treated with thiopurines. A single 3 cc heparinized blood sample will be obtained for TPMT genotyping. The sample will be obtained either simultaneously with a clinical sample, at the time of an otherwise medically indicated intravenous catheter placement or scavenged from excess blood remaining following clinical laboratory testing.

Official Title
-----------------
Evaluation of Thiopurine Methyltransferase Polymorphisms in the Hispanic Population

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

Intervention / Treatment
-----------------
* Procedure: Blood Sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Hispanic children and adolescents diagnosed and treated at Texas Children's Cancer Center within the last 5 years for malignant diseases/cancer and non-malignant hematological disorders that necessitate chemotherapy All Hispanic children and adolescents who will be treated at Texas Children's Center for malignant diseases/cancer and non-malignant hematological disorders that will necessitate chemotherapy. Exclusion Criteria: Any child or adolescent registering at Texas Children's Cancer Center and not requiring any form of therapy.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood Sampling|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
-----------------
Cancer, Chemotherapy, Hematological disorder
Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia

Study Overview
=================
Brief Summary
-----------------
A single supraphysiological course of exogenous corticosteroids is recommended between 24-34 weeks' gestation to minimize the adverse sequelae associated with prematurity. The 24-hour profile of endogenous corticosteroids normally follows a diurnal rhythm with the highest serum level occurs between 5am-11am and nadir over 12 hours.

Detailed Description
-----------------
A retrospective study from January 2010 to December 2017. Eligible for analysis are: singleton pregnancies between 24 - 34 weeks' gestation who were given a single course of intramuscular betamethasone. Single course comprised of two separate doses of 12 mg given 24 hours apart. Each woman was allocated into one of the four pre-defined groups based on the time the intramuscular betamethasone was administered; Group 1 (5am-11am), group 2 (11am-5pm), group 3 (5pm-11pm) and group 4 (11pm-5am). The investigators hypothesized that exogenous corticosteroids given during the nadir state of endogenous corticosteroids activity could alter maternal and fetal glucose homeostasis.

Official Title
-----------------
Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia: It's All About Timing

Conditions
-----------------
Hypoglycemia

Intervention / Treatment
-----------------
* Drug: Betamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • women between 24 - 34 weeks' gestation who were admitted and given a single course of intramuscular betamethasone for threatened preterm labor in our institution Exclusion Criteria: higher order multiple pregnancies women who were given more than one course of betamethasone during the course of the current pregnancy known major congenital anomalies.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Betamethasone group 1<br>Betamethasone Group 1 (5am-11am) | Drug: Betamethasone<br>* Corticosteroids<br>|
| Betamethasone Group 2<br>Betamethasone Group 2 (11am-5pm) | Drug: Betamethasone<br>* Corticosteroids<br>|
| Betamethasone Group 3<br>Betamethasone Group 3 (5pm-11pm) | Drug: Betamethasone<br>* Corticosteroids<br>|
| Betamethasone Group 4<br>Betamethasone Group 4 (11pm-5am). | Drug: Betamethasone<br>* Corticosteroids<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of neonatal hypoglycemia | Incidence of neonatal hypoglycemia, glucose ˂ 40 mg/dL at any time | 7 years |