linjc16/ctgov huggingface dataset:
Study of CS-3150 in Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal Impairment

Study Overview
=================
Brief Summary
-----------------
To examine antihypertensive effect and safety of administration of CS-3150 in combination with ARB or ACE inhibitor in hypertensive patients with moderate renal impairment.

Official Title
-----------------
A Study of CS-3150 to Evaluate Efficacy and Safety in Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal Impairment

Conditions
-----------------
Hypertension With Moderate Renal Impairment

Intervention / Treatment
-----------------
* Drug: CS-3150


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects aged 20 or order to 80 or younger years at informed consent Subjects with hypertension (Sitting SBP ≥ 140 mmHg, <180 mmHg and Sitting DBP ≥ 80 mmHg, <110 mmHg Treatment with an ARB or ACE inhibitor eGFR ≥ 30 mL/min/1.73 m2 and < 60 mL/min/1.73 m2 Exclusion Criteria: Secondary hypertension or malignant hypertension Diabetes mellitus with albuminuria Subjects under Insulin treatment Subjects under or pre-planned for hemodialysis Serum potassium level < 3.5 or ≥ 4.8 mEq/L

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CS-3150<br>CS-3150 1.25 to 2.5, 5mg, orally, once daily after breakfast for 12 weeks | Drug: CS-3150<br>* CS-3150 1.25 to 2.5, 5mg, orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitting systolic and diastolic blood pressure | Change from baseline in sitting systolic and diastolic blood pressure | Baseline to end of Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time course of systolic and diastolic blood pressure | Time course of systolic and diastolic blood pressure | Baseline to end of Week 12 | 
| Proportion of patients achieving blood pressure control | Proportion of patients achieving blood pressure control | Baseline to end of Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mineralocorticoid receptor antagonist, Moderate renal impairment, Hypertension
Ghrelin Decreases Insulin Sensitivity

Study Overview
=================
Brief Summary
-----------------
Ghrelin administration increases appetite and, in rodents, induces weight gain. The aim of this study is to investigate the effect of short term ghrelin administration to humans on metabolism.

Detailed Description
-----------------
The current study is initiated in order to assess the impact of acute ghrelin administration on insulin resistance measured by a hyperinsulinemic euglycemic clamp. Second, as free fatty acid is the predominant substrate during fasting, we aim to asses the effects of ghrelin on local and systemic lipolysis.

Official Title
-----------------
Intravenous Ghrelin Infusion Decreases Insulin Sensitivity in Healthy Young Men

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Ghrelin and saline (as placebo)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men, age >= 18 yr age < 50 yr, body mass index < 27.5 kg/m2above or equal to 18 yr Exclusion Criteria: any disease, use of prescribed medication, age < 18 yr or >= 50 yr

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br> | Drug: Ghrelin and saline (as placebo)<br>* Intravenous infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity |  | End of clamp period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on lipolysis |  | End of basal and end og clamp period |
Dermacyd PH_DESILSTY_FR (Lactic Acid) - Photo Evaluation - Stay on Frutal

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To demonstrate the absence of photoirritation and potential photosensitization of the product Dermacyd PHDESILSTYFR.

Official Title
-----------------
Study Title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DESILSTY_FR.

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: LACTIC ACID(ND)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Phototype Skin II and III Integral skin test in the region Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion Exclusion criteria: Lactation or pregnancy Use of Antiinflammatory 30 days and/or immunossupression drugs until 3 months before volunteers selection Disease which can cause immunosuppresion, such as diabetes, HIV Concomitant use of photosensitivity drugs History of sensitivity or photosensitivity with topic products Cutaneous active disease which can modify the study results History or activity of photodermatosis Personal or family antecedents of cutaneous neoplasia photo induced Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis Intense exposure solar in the test region Use of new drugs and/or cosmetics during the study Previous participation in studies using the same product in test Relevant history or confirmation of alcohol or other drugs abuse Intolerance detected or suspected for some component of the sample tested Medecin or sponsor employees or their close family. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermacyd PH_DESILSTY_FR (Lactic Acid)<br>Dermacyd PH_DESILSTY_FR (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also used as a control sample. | Drug: LACTIC ACID(ND)<br>* Treatment duration 5 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the photo irritation test and the photosensitivity byusing UVA irradiation and evaluation according to International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type. |  | From the treatment start to the end of the study (treatment period 5 weeks) |
ABT-378/Ritonavir and Efavirenz in HIV-Infected Patients Who Have Taken More Than One Protease Inhibitor in the Past

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if ABT-378/ritonavir plus efavirenz is safe and effective in lowering the amount of HIV in the blood of patients who have been treated with more than 1 protease inhibitor (PI).

Detailed Description
-----------------
All patients take ABT-378/ritonavir and efavirenz; there are no placebos in this study. Patients take study medications for 48 weeks, during which time there will be 15 study visits. There is a possibility of a study extension after 48 weeks.

Official Title
-----------------
A Phase II Study of ABT-378/Ritonavir and Efavirenz in Multiple Protease Inhibitor-Experienced Subjects

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

Intervention / Treatment
-----------------
* Drug: Lopinavir/Ritonavir
* Drug: Efavirenz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have a viral load (level of HIV in the blood) of at least 1,000 copies/ml. Have been receiving stable (no changes) anti-HIV treatment that includes at least 1 PI for at least 8 weeks prior to study entry. Have received more than 1 PI for at least 12 weeks each at some time in the past. Exclusion Criteria Patients will not be eligible for this study if they: Have had any active opportunistic (AIDS-related) infections within the past 30 days. Have ever received nonnucleoside reverse transcriptase inhibitors (NNRTIs), such as delavirdine, nevirapine, or efavirenz. Have received certain medications. Are pregnant or breast-feeding. Abuse alcohol or drugs.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lopinavir/Ritonavir|nan|
|Drug: Efavirenz|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
-----------------
HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, ABT 378, efavirenz
Composite Variability Index and Propofol Remifentanil Anesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if the new Composite Variability Index (CVI) is capable of detecting changing effect compartment concentrations of remifentanil. In addition, it is planed to detect if the change in CVI in response to a standardized painful stimulus is dose-dependent.

Detailed Description
-----------------
On the day of surgery, patients receive anesthesia by propofol infusion. As soon as the patient is unresponsive und unconscious (BIS 40-60) and a steady state is achieved, a standardized painful stimulus is applied by electrical stimulation of the ulnar nerve (tetanic stimulation [70 mA], 30 seconds, 50 Hz) in group 1. Thereafter remifentanil is infused to an effect compartment concentration target of 1 ng/ml. The standardized stimulus is applied again as the remifentanil target is reached. This procedure is repeated with remifentanil targets of 2 ng/ml and 3ng/ml. In group 2 remifentanil is targeted to effect compartment concentrations of 3 ng/ml followed by 2,1, and 0 ng/ml. After measuring the effect of the last painful stimulus the patient is intubated for surgery. Throughout the study the Composite Variability Index and standard monitoring is recorded.

Official Title
-----------------
Changes in the Composite Variability Index in Response to Different Remifentanil Concentrations and Standardized Painful Stimuli.

Conditions
-----------------
Measure of Nociception

Intervention / Treatment
-----------------
* Drug: rising remifentanil concentrations
* Drug: falling remifentanil concentrations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing surgical procedure in general anesthesia Exclusion Criteria: Pregnancy, drug abuse, cardiac arrhythmia, obesity

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br> | Drug: rising remifentanil concentrations<br>* remifentanil effect-compartment concentrations 0,1,2,3 ng/ml<br>|
| Active Comparator: Group 2<br> | Drug: falling remifentanil concentrations<br>* remifentanil effect-compartment concentrations 3, 2, 1, 0 ng/ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction Probability of CVI versus remifentanil effect compartment concentration and versus movement after painful stimulus |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Composite Variability Index, Bispectral Index, Electromyography, Nociception, Pain
Clinical Findings in General Paresis

Study Overview
=================
Brief Summary
-----------------
This is a study of the clinical and neuroimaging of general paresis. The investigators studied six patients with general paresis.

Detailed Description
-----------------
Inclusion Criteria: Mental disorders positive TPHA in CSF and sera HIV-negative serology by ELISA Exclusion Criteria: Negative TPHA in CSF and sera No image data

Official Title
-----------------
Xijing HOSPITAL, Fourth Military Medical University, China

Conditions
-----------------
General Paresis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: EEG MR Exclusion Criteria: Serological test

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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 |
| --- | --- |
| Mr Q, 40 years old<br>Dementia, sensory aphasia, irritability, hallucination MRI showed cortical lesion, mesial temporal lobe atrophy. | |
| Mr Guo,35 years old<br>Dementia, sensory aphasia, tremor, gait disturbance MRI showed cortical lesion, enlarged ventricle, white matter lesion, cerebral atrophy | |
| Mr Zhang,40 years old<br>Dementia, apraxia of speech, gatism , irritability, insomnia, gait disturbance MRI showed white matter lesion, cerebral atrophy. | |
| Mr Liu,40 years old<br>Dementia, apraxia of speech, irritability, insomnia MRI showed normal. | |
| Mr Zhang,54 years old<br>Dementia, apraxia of speech MRI showed white matter lesion, cerebral atrophy. | |

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
-----------------
EEG, general paresis, MRI, neurosyphilis
GI Interlab 2 Study: Measuring the Glycaemic Index (GI) of Foods

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the extent of and sources of variation in the glycaemic index values of foods measured by different laboratories around the world.

Detailed Description
-----------------
The glycaemic index values of 3 different foods provided from a central location will be determined in each of 20-30 centers around the world. A standard protocol will be followed, but this protocol leaves room for variation in certain details, such as whether subjects are allowed to have coffee or tea with the test meals or only water, or the method of analyzing blood glucose. Methodologic details, subject demographic information (height, weight, age, and ethnicity), results of local calculations and raw data will be sent to a central location.

Official Title
-----------------
Measuring the Glycaemic Index of Foods: Interlaboratory Study #2

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

Intervention / Treatment
-----------------
* Drug: Test Meal: Reference food (glucose or white bread)
* Drug: Test Meal: Pirate's Booty
* Drug: Test Meal: Ceaprove wafer
* Drug: Test Meal: Stretch Island Strawberry Fruit Leather


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects Exclusion Criteria: Diabetes Pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Test Meal: Reference food (glucose or white bread)|nan|
|Drug: Test Meal: Pirate's Booty|nan|
|Drug: Test Meal: Ceaprove wafer|nan|
|Drug: Test Meal: Stretch Island Strawberry Fruit Leather|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycaemic index |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| within-individual variation of glycaemic responses |  |  | 
| glycaemic responses assessed as incremental area under the curve |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glycemic index, Nutrition, Carbohydrates, Glycemic responses, Methodology, Healthy human subjects
The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Pilot Study

Study Overview
=================
Brief Summary
-----------------
The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease

Official Title
-----------------
The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Open Label, Pilot Study

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Device: Hip protection orthosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age from 1 to 15 Patients with severe neuromuscular disease Patients who agreed to participate in the study Hip dislocation more than 10% (migration index) Exclusion Criteria: If do not agree with the study Those who are determined to be difficult to participate under the judgment of the research director History of hip joint surgery

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br> | Device: Hip protection orthosis<br>* Experimental group would wear hip protection orthosis over 12 hours a day for 1 year.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migration index | Hip AP radiography | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cobb's angle (') | using radiography, expressed by degree from 0' to 180'. The closer to 0', the better the value. | 6 months | 
| Range of motion of hip joint (') | Using goniometer, measure the hip and knee abduction and flexion angle expressed by degree from 0' to 180'. The closer to 180', the better the value. | 6 months | 
| Visual analog scale | measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain. | 6 months | 
| Likert scale (score) | measure the satisfaction about hip protection orthosis expressed by score from 0 to 5. The closer to 5, the higher the satisfaction. | immediately after wearing orthosis | 
| Child Health Index of Life with Disabilities (CPCHILD) | measure the quality of life expressed by score from 0 to 100. The higher the quality of life. | 6 months |