linjc16/ctgov huggingface dataset:
Treating Amyotrophic Lateral Sclerosis (ALS) With R(+) Pramipexole Dihydrochloride Monohydrate at 60 mg/Day

Study Overview
=================
Brief Summary
-----------------
R(+) pramipexole dihydrochloride monohydrate [R(+)PPX], an experimental neuroprotective drug, is provided in this open label extension study to ALS patients who have participated in earlier clinical protocols.

Official Title
-----------------
Open Label Extension for Treating ALS With R(+) Pramipexole at 60 Milligrams Per Day

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Drug: R(+) pramipexole dihydrochloride monohydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Definite diagnosis of ALS Exclusion Criteria: No prior participation in R(+)PPX clinical studies

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: R(+) pramipexole dihydrochloride monohydrate|20 mg tid per day orally|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.

Study Overview
=================
Brief Summary
-----------------
Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.

Conditions
-----------------
Purulent Bacterial Conjunctivitis

Intervention / Treatment
-----------------
* Drug: T1225
* Drug: Tobramycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ one day of life and ≤ 18 years Purulent bacterial conjunctivitis

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T1225<br> | Drug: T1225<br>* one drop twice daily (morning and evening) in each eye from Day 0 to Day 2<br>|
| Active Comparator: Tobramycin<br> | Drug: Tobramycin<br>* 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3 | Clinical cure was defined as a score 0 for bulbar conjunctival injection (evaluated using a 4 point ordinal scale) and a score 0 for conjunctival purulent discharge (evaluated using a 4 point ordinal scale). | Day 3 |
Postmenopausal Progestins, MI and Stroke

Study Overview
=================
Brief Summary
-----------------
To evaluate the cardiovascular effects of postmenopausal hormone replacement therapy and the suspected beneficial effects on myocardial infarction and stroke.

Detailed Description
-----------------
BACKGROUND: Post-menopausal women who use estrogens generally experience at once a reduced risk of coronary heart disease and, at the same time, an increased risk of endometrial cancer. In order to protect the endometrium from unopposed estrogens, many physicians now recommend the addition of a progestin during 10-13 days of the cycle. Progestins may be implicated in the increased risk of myocardial infarction in women on oral contraceptives. DESIGN NARRATIVE: This was a case-control study. The computerized files of the Group Health Cooperative (GHC) in Seattle were used to identify cases. All postmenopausal women, aged 40 to 79, were eligible as cases if, according to World Health Organization criteria, they presented with a fatal or non-fatal myocardial infarction. A random sample of women listed in the enrollment files at GHC served as a source of potential controls. Review of the out-patient medical records, performed by an assistant blind to case-control status ensured that all study subjects met the same criteria. Telephone interviews were used to obtain information about exposure to postmenopausal hormones as well as known risk factors. The computerized pharmacy records at GHC provided additional information about exposure. Frequency matching controlled for the potential confounding effects of age and year of presentation. Stratification and logistic regression were used in data analysis. The study was renewed in 1995 to make more precise some of the indeterminate findings related to current use, cumulative dose and duration of use but also to extend the assessment of the risk or benefit to incident strokes. The study ended in January, 1999.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Coronary Disease, Cerebrovascular Accident, Myocardial Infarction, Postmenopause

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Detailed Pain Pattern After Laparoscopic Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Pain after laparoscopic groin hernia repair consist of different pain components (overall pain, shoulder pain, incisional pain and visceral pain). Thus it is important to find out which of these pain components that is most severe, so intervention can be targeted.

Detailed Description
-----------------
Details about the components of early pain after laparoscopic groin hernia repair are lacking. A description of each component (overall pain, shoulder pain,incisional pain and visceral pain) is needed, so intervention against the different pain components can be targeted. Patients fill out questionnaires about pain before operation and day 0-3 after operation.

Official Title
-----------------
Early Pain Pattern and Its Components After Laparoscopic Inguinal Hernia Repair

Conditions
-----------------
Inguinal Hernia, Femoral Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men 18-69 years uni- or bilateral hernia ASA I-II Danish speaking Exclusion Criteria: bad compliance acute operation daily intake of opioids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| lap. hernia repair<br>undergoing laparoscopic groin hernia repair | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall pain during coughing (visual analog scale) |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| shoulder pain during coughing (visual analog scale and verbal rating scale) |  | 3 days | 
| incisional pain during coughing (visual analog scale and verbal rating scale) |  | 3 days | 
| visceral pain during coughing (visual analog scale and verbal rating scale) |  | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain pattern, overall pain, incisional pain, shoulder pain, visceral pain
The Impact of Quetiapine on the Drug Abuse Patterns of Addicted Schizophrenic Patients

Study Overview
=================
Brief Summary
-----------------
The lifetime of substance use disorders in schizophrenia is close to 50%. Substance abuse in schizophrenia is associated with negative consequences. Unfortunately, there no clear guidelines for the pharmacological treatment of this dual diagnosis population. Preliminary results suggest that second-generation antipsychotic drugs (mainly clozapine) may relieve drug cravings in schizophrenia. We performed a 12-week pilot study to evaluate the impact of quetiapine, a second-generation antipsychotic, on substance abuse parameters, psychiatric symptoms and side effects in patients schizophrenia and comorbid substance use disorders. Our expectation was a 20 % decrease in drug cravings from baseline to end-point.

Official Title
-----------------
The Impact of Quetiapine on the Drug Abuse Patterns of Addicted Schizophrenic Patients

Conditions
-----------------
Schizophrenia, Substance Use Disorders

Intervention / Treatment
-----------------
* Drug: quetiapine (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with as schizophrenia spectrum disorder Patients with a comorbid substance use disorder Exclusion Criteria: Patients already on quetiapine or clozapine Patients hospitalized or acutely ill Total score lower than 65 on the PANSS Pregnancy Female subjects of childbearing potential without adequate contraception Abnormal liver function (hepatic enzymes more than 3 times the upper normal limits) Any clinically meaningful unstable renal, hepatic, cardiovascular, respiratory, cerebrovascular disease or other serious, progressive physical disease.

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: quetiapine (drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Left-Atrium-Appendage Occluder Register - GErmany

Study Overview
=================
Brief Summary
-----------------
Evaluation of safety and effectiveness of implantable LAA occluder in clinical practice Indication: For which reasons is the indication for implantation of LAA-Occluder put for patients with atrial fibrillation? Safety: How save is the implantation of LAA-Occluders? Effectiveness: How effective is implantation of LAA-Occluders in daily clinical practice? Concomitant treatment: Which concomitant treatment is prescribed for patients with LAA-Occluder?

Detailed Description
-----------------
LAARGE aims to show the care reality of patients whose left atrial appendage (LAA) is closed by an implantable medical device. In particular the following questions should be answered: Indication: For which reasons is the indication for implantation of LAA-Occluder put for patients with atrial fibrillation? Safety: How save is the implantation of LAA-Occluders (procedural, in hospital and in the long term course)? How frequent are bleeding complications and what is the relation of observed and expected bleeding complications (according HAS-BLED score)? Effectiveness: How effective is implantation of LAA-Occluders in daily clinical practice (in hospital and in the long term course)? How frequent are strokes and what is the relation of observed and expected strokes (according CHADS-VASC score)? Concomitant treatment: Which concomitant treatment is prescribed for patients with LAA-Occluder?

Official Title
-----------------
Left-Atrium-Appendage Occluder Register - GErmany

Conditions
-----------------
Stroke, Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intention to laa occluder Exclusion Criteria: Missing informed consent
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 |
| --- | --- | --- |
| Safety: clinical events with LAA occlusion | Documentation of reasons for LAA Occluder Implantation. Periprocedural and hospital: death, bleeding, pericardial effusion, reanimation, occluder dislocation and further complications. Long term follow-up:: death, bleeding, pericardial effusion, reanimation, occluder dislocation, further complications and patients safety. | 1 year follow-up (optional 2,3,5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness: LAA occlusion | periprocedural and hospital: Sudden or unexpected death, stroke, TIA, systemic embolism, technical success. Long term follow-up: Sudden or unexpected death, stroke, TIA, systemic embolism, patients satisfaction. | 1 year follow-up (optional 2,3,5 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LAA, LAA-Occluder, Atrial Fibrillation, AF
A+ Asthma Early Intervention in Asthma Management

Study Overview
=================
Brief Summary
-----------------
This project will evaluate the effectiveness of a Head Start-based early intervention for designed to improve asthma management skill and practices of parents, pre-school children and Head Start staff.

Detailed Description
-----------------
BACKGROUND: While increased asthma morbidity and mortality have been observed across all ethnicities, results from several studies have found that asthma morbidity has increased disproportionately in low-income African American children. Elementary school-based asthma education programs have shown promise in improving asthma management, and reducing asthma morbidity in this high-risk population, however, the fastest growing asthma risk is associated with children young than six. By elementary age many parents and children with asthma have well-established patterns of inappropriate asthma management that may be difficult to change. To date, no research has examined the impact of early intervention for asthma management in low-income, high-risk children. DESIGN NARRATIVE: Head Start sites will be randomized to either a minimal intervention control group or the A+ Asthma early intervention program designed to educate and assist Head Start teachers and family service coordinators to: optimize classroom management of asthma, educate, facilitate and reinforce appropriate parental medical and behavioral management of asthma, and instruct, model and reinforce early asthma knowledge and age-appropriate skills for preschool age children. The primary outcome that the study was designed to evaluate Head Start absences/days enrolled, determined by review of Head Start attendance records. The secondary outcomes specified in the protocol are health care utilization (emergency department visits, hospitalizations, primary care visits), asthma symptoms (restricted activity, symptom-free days, day and nighttime symptoms), asthma medications, parents' asthma-related quality of life, and parent, child and teacher asthma knowledge and management practices. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Behavioral: A+ Asthma early intervention program


Participation Criteria
=================
Eligibility Criteria
-----------------
Children aged 3 and 4 years who have asthma that is currently active

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 4 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: A+ Asthma early intervention program|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Comparative Study of Global 12 Lead Electroencephalogram to Frontal SedlineTM Electroencephalogram

Study Overview
=================
Brief Summary
-----------------
The fundamental reason for comparing the ability of the Frontal Sedline TM Electroencephalogram (PSA EEG) to standard Global 12 Lead Electroencephalogram (EEG) for burst suppression detection is to determine if a less expensive, less invasive and possibly more convenient bifrontal EEG monitor can be effective for evaluation of anesthesia-induced intraoperative burst suppression therapy (IBST) for cerebral protection.

Official Title
-----------------
A Comparative Study of Global 12 Lead Electroencephalogram to Frontal SedlineTM Electroencephalogram Monitoring for the Evaluation of Intraoperative Burst Suppression During Elective Craniotomy or Transphenoidal Pituitary Resection

Conditions
-----------------
Craniotomy, Transphenoidal Pituitary Resection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult ASA class 1-3 male or female 18-90 years of age; scheduled for elective craniotomy in the LLUMC University Hospital, for which the surgeon has requested intraoperative burst suppression therapy; capable of understanding and signing informed consent; willing to have dual EEG monitoring. Exclusion Criteria: Age under 18 years; emergency or trauma situation requiring craniotomy; surgical approach that prohibits placing the SEDLineTM array on the forehead; known sensitivity to the adhesives on the SEDLineTM array; lack of availability of standard EEG monitoring; patients with seizure disorders and refusal of consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Correlation between 4 channel PSA EEG and a global 12 lead EEG | The primary outcome measure is correlation between 4 channel frontal PSA EEG pattern and standard global 12 lead EEG during IBST. | 24 hours |
Routine Preoperative Hemostatic Laboratory Evaluation Prior to Tonsillectomy or Adenoidectomy in Children

Study Overview
=================
Brief Summary
-----------------
Routine analysis of coagulation profile is recommended before adenoidectomy, tonsillectomy or ventilation tubes insertion in children. A proportion of those children reveal borderline abnormal values of Partial Prothrombin Time (aPTT) or Prothrombin Time (PT) and then they are referred to a consultant hematologist for further evaluation and recommendations before surgery. The purpose of this study is to summarize the causes of referrals in a cohort of 200 children and to assess the further laboratory analysis preformed and the results obtained.

Detailed Description
-----------------
Data from about 200 children that were evaluated for abnormal coagulation tests performed before minor surgery. The data will include cause of referral, laboratory analysis performed and results. If the data allows the outcome of the operation and bleeding complications, will also recorded.

Official Title
-----------------
Routine Preoperative Hemostatic Laboratory Evaluation Prior to Tonsillectomy or Adenoidectomy in Children - a Necessity or Habitude?

Conditions
-----------------
Coagulation Abnormalities

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patients referred to the pediatric hematology unit for evaluation due to coagulation abnormalities before minor surgery Exclusion Criteria: No exclusion are applicable

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenoidectomy, Tonsillectomy, Ventilation Tubes, Preoperational screening, Coagulation Profile, Lupus anticoagulant
Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort

Study Overview
=================
Brief Summary
-----------------
The study of early, acute HIV infection is critical to understanding subtype-specific pathophysiologic differences, since up to 50% of acute HIV infections may be incapacitating. This study will establish whether the patient population of the Thai Red Cross Anonymous Clinic is suitable for the study of early, acute infection.

Detailed Description
-----------------
This study will utilize existing (collected after 1 January 2006) and prospectively collected HIV seronegative clinical specimens not used as part of any research protocol. The specimens in this study are discarded anonymous samples from the Voluntary Counseling and Testing (VCT) facilities at the Thai Red Cross Anonymous Clinic in Bangkok, Thailand. The specimens cannot be linked to the tested subjects. The samples will be labeled using the anonymous clinic identification number which is a 7 digit number with the first 2 digits representing the year and the following 5 digits representing the sequence of which the client sought care in that calendar year. Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort.

Official Title
-----------------
Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort.

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All clients who access services included in the Health Check Up Packages by Age Groups at the Thai Red Cross AIDS Research Centre. Exclusion Criteria: None
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV seronegative, acute infection