linjc16/ctgov huggingface dataset:
Cholesterol-lowering Effects of Plant Stanol Ester

Study Overview
=================
Brief Summary
-----------------
Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a smoothie is less well known.

Conditions
-----------------
Dyslipidemias, Hypercholesterolemia, Hyperlipidemias

Intervention / Treatment
-----------------
* Dietary Supplement: Plant stanol ester
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: total cholesterol concentration ≥ 200 mg/dL and < 300 mg/dL, and or LDL-C concentration ≥ 130 mg/dL and < 180 mg/dL were willing to consume control or plant stanol ester smoothie drinks two bottles per day immediately after a meal for four weeks, reachable by phone willing to declare written informed consent agreed in accordance with data protective stipulations and readiness to participate in the trial and to adhere to the study conditions. Exclusion Criteria: Pregnant women obese diabetic subjects or subjects with random plasma glucose concentration > 200 mg/dL hyperthyroidism, a history of metabolic, endocrine and kidney disorders acute or chronic severe diseases possibly interfering with the evaluation of the outcome of the clinical trial (such as AIDS, tumor diseases, malignant hypertension, cardiac insufficiency according to NYHA III-IV) taking lipid-lowering medication or other medications likely to affect lipid metabolism

Ages Eligible for Study
-----------------
Minimum Age: 20 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo smoothie<br> | Dietary Supplement: placebo<br>* Smoothie that contains placebo<br>|
| Experimental: Plant stanol ester smoothie<br> | Dietary Supplement: Plant stanol ester<br>* Smoothie that contains plant stanol ester<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (proportional) in LDL-C from baseline up to 4-weeks after plant stanol ester smoothie drink consumption. |  | 4 weeks |
Aspirin and Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients

Study Overview
=================
Brief Summary
-----------------
Research design: randomized, double-blind, placebo-controlled crossover study to evaluate the putative interference of low-dose aspirin (for 8 weeks) on enalapril antiproteinuric properties in microalbuminuric type 2 diabetes mellitus patients

Detailed Description
-----------------
Research design: randomized, double-blind, placebo-controlled crossover study Patients: Microalbuminuric (urinary albumin excretion [UAE]30-300 mg/d)type 2 diabetes mellitus patients without ischemic heart disease or peptic ulcer Aim:To evaluate the putative interference of low-dose aspirin (300 mg/d)for 8 weeks)on enalapril antiproteinuric properties in microalbuminuric type 2 diabetes mellitus patients Study protocol:Crossover randomization to 8 weeks of enalapril 10 mg/d plus aspirin (300 mg/d) or plus placebo, and a 6-week washout period. Measurement of UAE (immunoturbidimetry) and glomerular filtration rate (51Cr-EDTA), blood pressure and metabolic control at baseline and at the end of each period. Statistical analyses: Bland&Altman analyses for crossover trials.

Official Title
-----------------
Aspirin and the Antiproteinuric Effect of Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients: a Randomized, Double-Blind, Placebo-Controlled Study

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

Intervention / Treatment
-----------------
* Drug: aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes mellitus microalbuminuria Exclusion Criteria: ischemic heart disease peptic disease

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aspirin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary albumin excretion |  |  | 
| glomerular filtration rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aspirin, enalapril, microalbuminuria, glomerular filtration rate
An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
It is well understood that hypertension, dyslipidemia, and diabetes mellitus are the major risks of chronic kidney disease. Current guidelines recommend screening kidney estimated glomerular filtration function with serum creatinine. But it is not the utmost effective method and the GFR would be underestimated. Since good correlation was noticed between serum creatinine and chronic kidney disease, urinary microalbumin levels is better for patients with risks of chronic kidney diseases. With adequate and early education, or antihypertensive agents with angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB), all could alleviate renal function deterioration and the severity of proteinuria. As a result, high sensitive methods is urgent and needed for early screening and diseases following up under medication with ACEi and ARB in chronic kidney disease patients. In this project, the investigators are going to include the patients with typy II diabetes mellitus combining with hypertension who are treated with antihypertensive agents. Such volunteers will be treated with Candesartan 8-16mg/ day and maintain systolic blood pressure <130 mm/Hg, diastolic blood pressure < 80 mm/ Hg as the goal. Therefore, this project would make effort on correlation with urinary microalbumin and other biomarkers changes under Candesartan treatment- one of ARB medication for 12 weeks, and further exploration of new biomarkers that may be related to renal parenchymal injuries.

Official Title
-----------------
An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy

Conditions
-----------------
Diabetic Nephropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type II Diabetic disease with hypertension (BP: systolic 140-160 mm/Hg, diastolic 80-100 mm/Hg) for 8 weeks. HbA1c< 8.0% Cre. <1.5 g/dL and eGFR: 89 - 30 mL/min/1.73 m2 Exclusion Criteria: Pregnancy During the observation, BP: systolic >160 mm/Hg, diastolic >100 mm/Hg).

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 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
-----------------
Hypertension, Primary disease
Insulin Resistance and Insulin Secretion

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to examine the prevalence of metabolic risk factors (impaired insulin release and impaired insulin sensitivity) for type 2 diabetes mellitus in children and adults from a population that is at high risk for this disease. We hypothesize that at least one of these pre-diabetic traits will be evident in a large proportion of relatives of known type 2 diabetic children as compared to a control group of subjects without a family history of type 2 diabetes. By isolating these traits, it will be possible to determine the relative contributions of genes and environment to each trait and to identify those at risk for subsequent development of type 2 diabetes by virtue of having one trait. Ultimately, those individuals at risk, especially those with impaired insulin release, would hopefully benefit from intervention to prevent the weight gain that will 'unmask' their underlying pancreatic dysfunction and thus prevent or retard the development of type 2 diabetes.

Official Title
-----------------
Phenotypic Assessment of Insulin Resistance and Insulin Secretory Capacity

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Ascertainment criteria for probands: age 10-20 years and obesity (BMI >85% for sex and age) diabetic criteria as described above or family history (first or second degree relative) with type 2 diabetes

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: diet|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
-----------------
diabetes
Colesevelam Versus Placebo in Cholestatic Pruritus

Study Overview
=================
Brief Summary
-----------------
38 patients with pruritus due to chronic cholestatic liver disease will be evaluated in an investigator initiated, multicenter, double-blind, placebo-controlled, 3-week study assessing the effects of colesevelam on pruritus. Colesevelam is an oral, non-absorbable bile-acid sequestrant much more potent than cholestyramine but free of adverse effects. It is registered as a lipid lowering agent. The intensity of symptoms will be scored by means of daily Visual Analogue Scales (VAS). Fatigue, quality of life and cutaneous scratch lesions will also be evaluated using quantitative instruments.

Official Title
-----------------
Colesevelam Versus Placebo in Cholestatic Pruritus. A Double-blind, Placebo-controlled Study

Conditions
-----------------
Chronic Liver Disease

Intervention / Treatment
-----------------
* Drug: colesevelam
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with pruritus as a result of a cholestatic disorder age above 18 years informed consent Exclusion Criteria: use of cholestyramine pregnancy inability to understand or speak Dutch language malignancy/life expectancy <6 months

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Verum; colesevelam | Drug: colesevelam<br>* 2 times 3 625 mg tablets daily, 3 weeks<br>* Other names: Cholestagel;|
| Placebo Comparator: 2<br>placebo | Drug: placebo<br>* 2 times 3 625mg tablets daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 40% reduction of pruritus according to visual analogue scores |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in quality of life scores |  | 3 weeks | 
| Reduction in pruritus score/scratch lesions |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholestatic, pruritus, of any cause
Family Process, Adherence, and Child Asthma Outcome

Study Overview
=================
Brief Summary
-----------------
To examine the role of family processes in asthma regulation in three groups of children with mild to moderate asthma.

Detailed Description
-----------------
DESIGN NARRATIVE: The study, which was ancillary to the Childhood Asthma Management Program (CAMP), clarified the extent to which and the mechanisms whereby specific family processes might be protective or deleterious in the adherence behaviors and treatment outcome in three groups of children with mild to moderate asthma: 80 children participating in the Denver site of the CAMP, 80 children receiving asthma-related care in a large, nationally recognized health maintenance organization, and 60 children recruited by using school records to identify children with asthma receiving their care in a variety of different health care systems across the Denver metropolitan area. The study examined the extent to which family process variables were cross-sectionally associated with and longitudinally influenced adherence to asthma treatment and asthma treatment outcome as well as the consistency of this relationship across the three sites. The study also determined whether adherence with treatment mediated the relationship between specific family processes and asthma treatment outcome, as well as the consistency of this relationship across the three sites. 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, Lung Diseases

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 |
| --- | --- | --- |
The Effect of Trazodone on the Severity of Obstructive Sleep Apnea in Insomnic Stroke Patients With Depression

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that trazodone does not worse nocturnal oxygen saturation in insomnic ischemic stroke patients with obstructive sleep apnea (OSA) and depression and has beneficial effect in selected stroke patients with low arousal threshold phenotype OSA.

Official Title
-----------------
The Effect of Trazodone on the Severity of Obstructive Sleep Apnea in Insomnic Stroke Patients With Depression

Conditions
-----------------
Sleep Apnea Syndromes, Cerebral Infarction

Intervention / Treatment
-----------------
* Drug: Trazodone
* Drug: Placebo oral tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Insomnic ischemic stroke patients with OSA and depression. Exclusion Criteria: unclear consciousness, unstable vital sign or neurologic sign, unstable medical conditions such as delirium, active infection, evidence of overt congestive cardiac failure, liver dysfunction with ascites, thyroid disease, end-stage-renal-disease receiving dialysis. overnight mean oxygen saturation (SaO2) nadir is ≤ 70% at baseline take monoamine oxidase inhibitors (MAOI), any medication that may affect breathing, sleep, or muscle activity any known allergy to trazodone sleep disorder other than OSA (e.g., periodic leg movement syndrome, restless legs syndrome, central sleep apnea/Cheyne-Stokes respiration).

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Trazodone<br>take trazodone 100mg hs | Drug: Trazodone<br>* take trazodone 100mg before polysomnography<br>|
| Placebo Comparator: Placebo<br>take placebo pill hs | Drug: Placebo oral tablet<br>* take placebo oral tablet before polysomnography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nocturnal oxygen saturation | mean and minimum oxyhemoglobin saturation (%) detected by pulse oximetry during polysomnography study | the polysomnography study night before take drug | 
| Sleep apnea severity index | apnea-hypopnea index, desaturation index according to The American Academy of Sleep Medicine (AASM) scoring manual version 2.0.3: Obstructive apnea: no airflow >= 10 s with respiratory effort (per hour of time); central apnea: no airflow without respiratory effort (per hour of time). Hypopnea: airflow decrease >30% lasting >= 10 s, followed by either oxygen desaturation > 3% or EEG arousal (per hour of time). The desaturation index: number of desaturations per hour of time. | the polysomnography study night before take drug |
Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms

Study Overview
=================
Brief Summary
-----------------
This is an open-label extension study of another study protocol, MCS-2-TWN-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for this study.

Detailed Description
-----------------
This open-label extension study is designed to further assess the long-term safety and efficacy of MCS-2. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for another 40 weeks of MCS-2 treatment at the same daily dosage as the active treatment given under the protocol MCS-2-TWN-a. Subjects are limited to those who are currently not being treated medically for BPH or LUTS.

Official Title
-----------------
Open-Label, 40-weeks Extension of Protocol MCS-2-TWN-a to Further Evaluate the Efficacy and Safety of MCS-2 for the Treatment of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naïve Male Subjects

Conditions
-----------------
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: MCS-2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has completed 12 weeks of treatment under the protocol MCS-2-TWN-a. Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form for participation in this extension study. Exclusion Criteria: Subject has severe LUTS at the last visit under the protocol MCS-2-TWN-a. Subject is considered ineligible for the study by the investigator(s).

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

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

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: MCS-2<br>2 soft-gel capsules Qd for 40 weeks | Drug: MCS-2<br>* 2 soft-gel capsules Qd for 40 weeks<br>* Other names: MUS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events |  | 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in International Prostate Symptom Scores (I-PSS) |  | 40 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Benign Prostatic Hyperplasia, BPH, MCS-2, Multi-Carotenoids, Lower Urinary Tract Symptoms, International prostate symptom score
AiM Covid Self Monitoring

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to test the level of accuracy of the prediction models that could be used as a 'digital test' to evaluate whether an individual is infected with COVID-19, based on their symptoms reported in the AiM COVID-19 app

Official Title
-----------------
Efficacy of AiM Covid Self Monitoring in Detecting Infection of COVID-19

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: Other


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants resident in India Voluntary completion of the self-test and evaluation. Exclusion Criteria: People can not use mobile app Below 18 years old

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AiM Covid<br>Self Monitoring of symptoms in AiM Covid App | Other: Other<br>* No Intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fever | Self reported body temperature (Degrees Celsius) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shortness of Breath | Self reported shortness of breath symptom (tick box) | 1 day | 
| Cough | Self reported cough symptom (tick box) | 1 day | 
| Sore Throat | Self reported soar throat symptom (tick box) | 1 day | 
| Headache | Self reported headache symptom (tick box) | 1 day | 
| Muscle/ Joint Pain | Self reported muscle/ joint pain symptom (tick box) | 1 day | 
| Diarrhoea | Self reported diarrhoea symptom (tick box) | 1 day | 
| Vomiting/ Nausea | Self reported vomiting/ nausea symptom (tick box) | 1 day | 
| Runny Nose | Self reported runny nose symptom (tick box) | 1 day | 
| Loss of Smell/Taste | Self reported loss of smell/ taste symptom (tick box) | 1 day | 
| Other symptoms | Self reported other symptoms (tick box) | 1 day |