linjc16/ctgov huggingface dataset:
Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction

Study Overview
=================
Brief Summary
-----------------
To reduce antipsychotics to under 1000mg in patients with schizophrenia taking more than 1000mg/day and to evaluate relationship between relapse and cognitive function.

Detailed Description
-----------------
We attempted to reduce the dose of antipsychotics to ≤1000-mg chlorpromazine eq./day. The dose was gradually reduced at a rate of ≤50-mg chlorpromazine eq./week, and the reduction was discontinued if the subjects relapsed. The differences in baseline cognitive function were analyzed between the patients with no relapse and relapse groups.

Official Title
-----------------
Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction in Patients Undergoing High-dose Antipsychotic Therapy

Conditions
-----------------
Schizophrenia Relapse

Intervention / Treatment
-----------------
* Drug: reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inpatients with a diagnosis of schizophrenia, and those in the chronic phase receiving mean daily antipsychotic doses exceeding 1000-mg chlorpromazine eq./day. Exclusion Criteria: mental retardation, substance abuse or dependence, a history of major head trauma, serious medical or neurological disorders, or depot antipsychotic injections within the previous 3 months and electroconvulsive therapy within the previous 6 months

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: reduction group<br>dose reduction of antipsychotics at a rate not exceeding 50mg chlorpromazine equivalent/week | Drug: reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Relapse | The definition of relapse is as follows 1.50% or greater increase in total DIEPSS score, 2. an increase in the total PANSS score of 25% or more from baseline, 3. deliberate self-injury, 4. emergence of clinically significant suicidal ideation, 5. violent behavior resulting in clinically significant injury to another person or property damage. | One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first. |
Comparator Study of LT-NS001 in Healthy Subjects With Endoscopic Evaluation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare naproxen plasma levels and gastroduodenal mucosal injury after administration of LT-NS001 as compared to Naprosyn in subjects age 45-70.

Official Title
-----------------
A Double-Blind, Randomized, Active Comparator Study of LT-NS001 Versus Naprosyn for Seven Days in Healthy Subjects With Endoscopic Evaluation

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: LT-NS001
* Drug: Naprosyn®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 18-30 kg/m2 No NSAID's for 14 days prior to baseline endoscopy Exclusion Criteria: Pregnant/Nursing women History of documented gastroduodenal ulcer

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: LT-NS001<br>* 1200 mg b.i.d. p.o. for 7.5 days<br>|
| Active Comparator: B<br> | Drug: Naprosyn®<br>* 500 mg b.i.d. p.o. for 7.5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of GI mucosal injury by endoscopy |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of naproxen PK at steady state |  | 7.5 days |
The Effect of Custom-Made Biomechanical Perturbation Platform on Kinetics, Kinematics and Electromyography in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Introduction: Kinetic, kinematic and electromyographic activity of the lower limb have been shown to be influenced by various footwear-generated biomechanical manipulations (e.g. soles. Insoles, orthoses). A novel biomechanical device comprising four modular elements attached onto foot-worn platforms was recently developed. Each element can be individually calibrated (Position, convexity, height and resilience) to induce a specific biomechanical challenge. Objectives: The aim of this study is to evaluate the influence of specific biomechanical challenges on Kinetics, kinematics and electromyographic activity of the lower limb. Design: Prospective, case control Setting: Motion analyses will be conducted during level walking with (1) a three-dimensional motion analysis system and (2) ground reaction force analysis using force platforms (3) Electro-Myography system. Each subject will be examined in 16 different settings of the biomechanical system

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: APOS biomechanical gait system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Similar anthorpometric profile (i.e. weight, shoe size, height, dominant leg) Exclusion Criteria: Previous orthopedic, musculosceletal or neurological pathology

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: APOS biomechanical gait system|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
-----------------
EMG, Kinetics, Kinematics, Perturbation, Footwear
Acid-suppressing Drugs Pregnancy Asthma Offspring Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is To estimate the association between prenatal exposure to proton pump inhibitors (PPIs) and the risk of asthma during childhood. To estimate the association between prenatal exposure to H2-receptor antagonists (H2RAs) and the risk of asthma during childhood.

Detailed Description
-----------------
A cohort study on the association between acid-suppressing drugs in pregnancy and asthma in the offspring

Official Title
-----------------
A Cohort Study on the Association Between Acid-suppressing Drugs in Pregnancy and Asthma in the Offspring

Conditions
-----------------
Asthma in Offspring

Intervention / Treatment
-----------------
* Drug: Risk of asthma in offspring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Females aged 18-45 years with at least one pregnancy between 1 January 1995 - 31 December 2010 (see study population description) Exclusion Criteria: - Males, females below age 18 and 45 years and above (see study population description)
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All women exposed to PPI at any time during pregnancy<br>Exposure to PPI defined as presence of at least one prescription of a PPI any time between last menstrual period and delievry date | Drug: Risk of asthma in offspring<br>* Exposure to PPI or H2RA, respectively during pregnancy No exposure to acid suppressing drugs during pregnancy<br>|
| All women exposed to H2RA at any time during pregnancy<br>Exposure to H2RA defined as presence of at least one prescription of H2RA any time between last menstrual period and delivery date | Drug: Risk of asthma in offspring<br>* Exposure to PPI or H2RA, respectively during pregnancy No exposure to acid suppressing drugs during pregnancy<br>|
| Pregnant women with no recorded use of acid suppressing drugs<br>Pregnant women with no recorded use of acid suppressing drugs at any time during pregnancy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative risk of first asthma diagnosis associated with prenatal exposure to proton pump inhibitors |  | From 1 January 2005 till 31 December 2010, an expected average of 5 years. | 
| Relative risk of first asthma diagnosis associated with prenatal exposure to histamine-2 receptor antagonists |  | From 1 January 2005 till 31 December 2010, an expected average of 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma,, acid-suppressing drugs,, pregnancy,, epidemiology
Registeranalysis for the Examination of NOMI

Study Overview
=================
Brief Summary
-----------------
The registry includes patients undergoing cardiovascular and thoracic surgery at the Saarland University Medical Center, Homburg/Saar, Germany. This study is a monocentric, retrospective study investigating the development of NOMI and outcome of patients.

Detailed Description
-----------------
All data were acquired from the hospital electronic health record and the picture archiving computer system (PACS). NOMI was suspected if the following clinical signs occured: new onset of oliguria (urine output <0.5 mL/kg/hour for at least 6 hours) or anuria, abdominal distention with decreased or absent bowel sounds, elevated serum lactate levels >5.0mmol/L or metabolic acidosis (base excess <-5mmol/L). In accordance to the definition of cardiogenic shock angiography was performed in patients with a systolic blood pressure >90 mmHg and a cardiac index >1.8 L/minute/m².

Official Title
-----------------
Interdisciplinary Retrospective Registeranalysis for the Examination of Non-occlusive Mesenteric Ischemia (NOMI)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The investigators include anonymous data from patients with cardio-thoracic surgery Exclusion Criteria: None

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- |
| NOMI<br>Patients suffering from NOMI | |
| No-NOMI<br>Patients not suffering from NOMI | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of NOMI | Clinical signs of NOMI | at the day of surgery, day zero | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Length of stay will be measured upon the time spent on intensive care unit and in the hospital | at the day of surgery, day zero up to 365 days | 
| Mechanical ventilation | Length of mechanical ventilation will be measured upon the time spent on intensive care unit | at the day of surgery, day zero up to 365 days | 
| Mortality | Mortality will be measured upon patients leaving the hospital dead or alive. | at the day of surgery, day zero up to 365 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NOMI, Angiography, Digital Subtraction Angiography (DSA)
Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

Study Overview
=================
Brief Summary
-----------------
Rhinosinusitis disorders are often associated with Cystic Fibrosis. They can restrict quality of life enormously and give cause to repeated ENT surgery. The basic defect in CF is a dysfunction of Chloride channels in exocrine glands, leading to retention of secretions and consecutive chronic inflammation with bacterial superinfections. The prospective placebo controlled cross-over study aims at the evaluation of the efficacy of a nasally inhalation of Pulmozyme with respect to mucus retention and resulting inflammation.

Official Title
-----------------
Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

Conditions
-----------------
Cystic Fibrosis, Chronic Rhinosinusitis

Intervention / Treatment
-----------------
* Drug: Pulmozyme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (most important): Subject has a confirmed diagnosis of cystic fibrosis. Subject has chronic or recurrent rhinosinusitic disorders. Subject is 5 years or older. Exclusion Criteria (most important): Subject has a critical condition (FEV1<30% and SaO2<93%). Subject had an ENT surgery within 6 months prior to study.

Ages Eligible for Study
-----------------
Minimum Age: 5 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dornase alfa<br>DBPC-cross over trial | Drug: Pulmozyme<br> <br> |
| Placebo Comparator: isotonic saline<br> | Drug: Pulmozyme<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in sinonasal symptoms (SNOT-20 |  | 2 yrs |
Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion

Study Overview
=================
Brief Summary
-----------------
This study proposed to construct an ultrasound-based diagnostic model for Differentiating Malignant Breast Lesion From Benign Lesion. This study contains both retrospective and prospective part, which are designed for model construction and independent validation, respectively.This study aims to construct an easy-to-use ultrasound-based model, prove the efficacy of the model for identifying malignant breast lesion from benign lesion, and finally promote the application of this diagnostic model in more clinics.

Official Title
-----------------
Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion

Conditions
-----------------
Breast Cancer Female, Diagnoses Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female with single breast lesion(maximum diameter>0.8 cm) agree to receive follow-up in six months and take the second breast ultrasound six month after the first breast ultrasound, if a benign diagnosis is achieved at the first ultrasound sign the informed consent Exclusion Criteria: lost to follow-up failed to take the second breast ultrasound six month after the first breast ultrasound

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suspicious breast lesions<br>women with Suspicious breast lesions, who need to receive breast ultrasound will be collected in this cohort. According to the diagnosis of breast ultrasound，patients will be assigned to breast biopsy or follow-up | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breast biopsy proved malignant or benign lesion | for patients regarded as malignant by the breast ultrasound, breast biopsy results are used as reference test, which determines the breast lesion is malignant or benign | between breast ultrasound and biopsy(one week) | 
| two breast ultrasound identified benign lesion | for patients regarded as benign by the breast ultrasound, they will receive a second breast ultrasound after six month(this is regular examination for patients with first detected breast lesion). If the second ultrasound indicates benign, the lesion will be regarded as benign | between first detection of breast lesion and the second ultrasound(six month) |
Diet and Plasma Cholesterol - Secular Trend Analysis

Study Overview
=================
Brief Summary
-----------------
To define the role of dietary variables on changes in plasma cholesterol levels over time in the Framingham cohort and the Framingham Offspring cohort.

Detailed Description
-----------------
BACKGROUND: Mortality from coronary heart disease has declined over 40 percent since the late 1960s. Possible explanations for the decline include the observed trends in risk factors such as changes in rates of hypertension, dyslipidemia, and glucose intolerance; lifestyle changes such as improvements in diet and decreases in the levels of cigarette smoking; and better detection and treatment of heart disease. The specific effects of risk factor, lifestyle, or detection and treatment changes on the declining population rates of coronary heart disease morbidity and mortality were unknown in 1990. Secular trend analyses were needed to elucidate the relative contribution of these factors, particularly dietary variables, on population rates of coronary heart disease. DESIGN NARRATIVE: Multiple regression was used to assess the effect of dietary variables on changes in serum cholesterol between 1957-1960 and 1966-1969 in a sample of 200 men for whom repeated measurements existed in the Framingham cohort. Analysis of covariance was used to assess influence of dietary intake on differences in serum cholesterol levels between independent samples of men studied in 1957-1960 and 1966-1969 in the Framingham cohort, and independent samples of women studied between 1957-1960 and 1984-1988 in the Framingham cohort and Offspring cohort, and independent samples of men studied between 1966-1969 and 1984-1988 in the Framingham cohort and Offspring cohorts respectively. 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
-----------------
Cardiovascular Diseases, Heart Diseases, Coronary Disease, Hypercholesterolemia

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 |
| --- | --- | --- |
Efficacy and Safety of 100IR, 300IR, 500IR Sublingual House Dust Mite (HDM) Tablets in Allergic Rhinitis Environment Exposure Chamber Model

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of 3 doses of sublingual house dust mite (HDM) tablets versus placebo in the change from baseline of rhinitis total symptom score during the allergen chamber challenge before and after 6 months of treatment.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase II Study to Assess the Efficacy and Safety of 100IR, 300IR and 500IR Sublingual Tablets of House Dust Mite Allergen for the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber Model

Conditions
-----------------
House Dust Mites Allergic Rhinitis

Intervention / Treatment
-----------------
* Biological: 100IR
* Biological: 300IR
* Biological: 500IR
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of HDM rhinitis allergy for > 1 year sensitized to D. pteronyssinus and/or D. farinae RTSS >= 6 at least 2 time points during allergen challenge session Exclusion Criteria: co sensitization to other allergen than HDM FEV1 < 80% Asthma GINA > 1

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100IR<br> | Biological: 100IR<br>* 100IR sublingual tablet of<br>|
| Experimental: 300IR<br> | Biological: 300IR<br>* 300IR sublingual tablets of<br>|
| Experimental: 500IR<br> | Biological: 500IR<br>* 500IR sublingual tablet of<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo sublingual tablet of<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rhinitis total symptom score (RTSS) | Rhinitis total symptom score = sneezing+rhinorrhea+nasal pruritus+ nasal congestion scored on 0-3 scale, total score range 0-12 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | Analysis of adverse events | 6 months and 18 months | 
| Rhinitis total symptom score | Rhinitis total symptom score=sneezing+rhinorrhea+nasal pruritus+nasal congestion scored on 0-3 scale, total score range 0-12 | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HDM, allergic rhinitis