linjc16/ctgov huggingface dataset:
Prevention and Early Detection and Intervention of Post-Coronary Artery Bypass Grafting Surgery (CABG) Acute Kidney Injury (AKI)

Study Overview
=================
Brief Summary
-----------------
Nephrology participation in care of patients undergoing CABG could reduce AKI through correction of modifiable risk factors and early detection and intervention of post-op AKI.

Official Title
-----------------
Prevention and Early Detection and Intervention of Post-Coronary Artery Bypass Grafting Surgery (CABG) Acute Kidney Injury (AKI)

Conditions
-----------------
Acute Renal Injury, Preventive Measures

Intervention / Treatment
-----------------
* Procedure: Standard of Care plus Nephrology Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (Age >18 years) Elective CABG at Mayo Clinic Rochester and Shanghai Zhongshan Hospital from 7/1/2016 to 6/30/2017 Exclusion Criteria: Non-elective CABG Renal failure on dialysis Renal transplantation

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>If participants are randomized into the non-intervention group, the participants' information during the study period will be collected. Participants will be managed by a care provider as per the standard of care. Participants may receive nephrology consultation as indicated clinically. | |
| Experimental: Standard of Care plus Nephrology Care<br>If participants are randomized into the intervention group, participants' information will be checked by the study investigators daily for 7 days (2 days pre-op and 5 days post-op). When appropriate, investigators may give suggestions to minimize the participants' risk(s) for AKI. Participant's primary care providers may take the suggestions into consideration. Participants' primary care providers are not obligated to carry out the suggestions that are given. | Procedure: Standard of Care plus Nephrology Care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfusion pressures (mean arterial pressure) ≥ 65-70 mmHg |  | baseline to 5 days |
Intra Cranial EEG Activity During Dexmedetomidine Sedation

Study Overview
=================
Brief Summary
-----------------
Various parts of the brain are sensitive to various anesthetics.We like to study the effect of dexmedetomidine on the different parts of the brain in patients who are coming for DBS electrode removal under sedation.

Detailed Description
-----------------
Cortical and sub cortical structures will have different sensitivities to various anesthetics.The objective of this study is to look at the changes in the intracranial electroencephalographic (EEG) characteristics during dexmedetomidine sedation and to determine the differences in the EEG characteristics between cortical and subcortical structures.

Official Title
-----------------
Intra Cranial EEG Activity During Dexmedetomidine Sedation.Comparing the Effects of Dexmedetomidine on the Cortical and the Sub Cortical(Hippocampus) Structures.

Conditions
-----------------
Complex Partial Seizures

Intervention / Treatment
-----------------
* Other: EEG Recording


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults between 18 to 80 years of age, who are scheduled for elective removal of intracranial (surface and depth) electrodes under conscious sedation Exclusion Criteria: Lack of informed consent Hypersensitivity to dexmedetomidine Language barrier Emergency surgery

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: EEG Recording|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iEEG Recording | iEEG data from each patient was analyzed using MATLAB (Natick, MA, USA). Data were presented as power spectral density, also referred to as the power spectrum or spectrum which quantifies the frequency distribution of energy or power within a signal. The spectrogram is a time-varying version of the spectrum. In these spectrograms, frequencies are arranged along the y-axis, and time along the x-axis, and power is indicated by color on a decibel (dB) scale. The power spectrum was computed for each channel using The Fast Fourier Transform (FFT). A window length of 20,000 data points was chosen in order to incorporate 4 cycles of a 1 Hz signal. The length of each window was therefore 4 seconds. A Hanning window was used to avoid edge effects of the windowing procedure. The length of the FFT was chosen to be 32768, which is the next power of 2 of the window length. The window overlap was set to zero. | 1 day |
The Effect of a Deep-fried Chocolate Bar or Porridge on Cerebral Blood Flow

Study Overview
=================
Brief Summary
-----------------
The deep fried chocolate bar is a snack that the international community strongly associates with Scotland. It has previously been cited as being a symbol of all that is wrong with the high-fat, high-sugar Scottish diet. Despite the snack's reputation, no medical research has been performed to examine the effects of consuming a deep fried chocolate bar on the human body. In contrast to the deep fried chocolate bar, porridge has been shown to reduce the risk of cardiovascular disease, but its effect on cerebral blood flow has yet to be directly assessed. This study will focus on the potential (patho)physiological cerebrovascular effects of the deep fried chocolate bar and porridge. The research question to be addressed in this study is Does eating a deep fried chocolate bar or bowl of porridge induce changes in cerebral blood flow and cereborvascular reactivity in healthy adults? To assess the acute effects on eating either food on blood flow through the largest artery in the brain, the investigators will give healthy volunteers one regular-sized deep-fried chocolate bar or a bowl of porridge. Blood flow through the largest artery in the brain will be assessed using simple ultrasounds tests. The investigators aim to recruit 24 volunterrs who will visit twice, consuming a different food on each visit.

Official Title
-----------------
A Randomised Trial of Effect of Deep-fried Chocolate Bar and Porridge Upon Cerebrovascular Reactivity in Healthy Adult Volunteers

Conditions
-----------------
Effect on Cerebrovascular Reactivity

Intervention / Treatment
-----------------
* Dietary Supplement: chocolate bar
* Dietary Supplement: Porridge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 18 and 30 No regular medication Able to provide informed consent Exclusion Criteria: Distaste for or contraindication to deep-fried chocolate bar or porridge ingestion inability to perform breath-hold

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chocolate bar<br> | Dietary Supplement: chocolate bar<br> <br> |
| Experimental: porridge<br> | Dietary Supplement: Porridge<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in breath hold index after ingestion of deep-fried chocolate bar compared with change after porridge ingestion |  | 4 weeks |
COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation

Study Overview
=================
Brief Summary
-----------------
This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled ovarian stimulation using clomiphene citrate, letrozole, and low-dose hMG on the number of oocytes retrieved.

Official Title
-----------------
Evaluation of a Simplified Low-cost and Friendly Controlled Ovarian Stimulation Combining Oral Letrozole and Clomiphene Citrate: a Pilot Study

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: COOL-COS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women scheduled to controlled ovarian stimulation for oocyte retrieval. Body mass index: 18-35 Kg/m2. Ultrasound scan up to the third day of a menstrual cycle with absence of a dominant and active follicle (follicle >10mm and serum estradiol ≥ 40 pg/L). Signing an informed consent. Exclusion Criteria: No exclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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: COOL-COS<br>All women will receive the intervention: Letrozole, Clomiphene, and low-dose hMG for the controlled ovarian stimulation. | Drug: COOL-COS<br>* Controlled ovarian stimulation will start on the second or third day of a menstrual cycle: Oral clomiphene citrate: 100 mg/day until the day of the triggering. Oral letrozole: 7.5 mg/day during the first 5 days of the controlled ovarian stimulation. hMG: 150 IU every other day beginning on the day 6 of the controlled ovarian stimulation. The triggering will be performed using urinary hCG (5,000 IU subcutaneous). 1-2 days after the identification of one follicle ≥ 17 mm 0-1 days after the identification of one follicle ≥ 19 mm.<br>* Other names: Friendly COS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved |  | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of embryos |  | 17 days | 
| Ovarian hyper-stimulation syndrome |  | 1 month |
3-Year Observational Virology Follow-up Study in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals

Study Overview
=================
Brief Summary
-----------------
All subjects in this study have previously been in an Idenix HCV study and received study drug for 3 consecutive days. Subjects who had received placebo in a previous Idenix study will not be enrolled in this study. In this study, researchers will try to find answers to these questions: How much (if any) hepatitis C virus is in your blood after stopping your Idenix study drug? Is your hepatitis C virus possibly resistant to treatment with the Idenix study drug or similar drugs?

Detailed Description
-----------------
The data obtained from this study will be used to further understand the long-term efficacy of Idenix DAAs used to treat HCV infection and to further understand HCV resistance to Idenix DAAs.

Official Title
-----------------
3-Year, Observational Study to Evaluate the Durability of Sustained Viral Response and the Kinetics of Antiviral-Resistant HCV in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals

Conditions
-----------------
Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained Have participated in an Idenix-sponsored study of an Idenix DAA Received at least 3 consecutive days of DAA treatment in an Idenix-sponsored study Agreed to comply with the visit schedule and laboratory tests Exclusion Criteria: Treatment with placebo only, in an Idenix sponsored study Antiviral treatment for HCV after participation in an Idenix sponsored study of an Idenix DAA

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Durability of Sustained viral response [SVR] | To evaluate the durability of sustained virological response (SVR). Plasma HCV RNA levels will be monitored over time. | every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinetics of resistant variants | To describe the kinetics of resistant variants to Idenix direct acting antivirals (DAAs) by HCV RNA sequencing. The presence of each identified resistant variant in the viral population will be descriptively evaluated until the viral population consists entirely of wild-type virus or over a period of 3 years, whichever comes first. | every 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCV, Hepatitis C, IDX184, IDX719
Bio-equivalence Vasoconstriction Activity Study for Topically Applied Clocortolone Pivalate 0.1% Cream

Study Overview
=================
Brief Summary
-----------------
To compare pharmacodynamic vasoconstriction response profile of Clocortolone Pivalate 0.1% Cream and Cloderm® (Clocortolone Pivalate) 0.1% Cream in normal skin of healthy male and female adults

Official Title
-----------------
Single Exposure Bioequivalence Study to Evaluate the Vasoconstriction Activity of Topically Applied Cloderm® (Clocortolone Pivalate) 0.1% Cream and Clocortolone Pivalate 0.1% Cream (Taro Pharmaceuticals) in Healthy Male and Female Volunteers With Normal Skin Under Occlusive Conditions.

Conditions
-----------------
Bioequivalence Study

Intervention / Treatment
-----------------
* Drug: Clocortolone Pivalate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal or clinically insignificant dermatological history the Screening visit and Day 1dosing; Exclusion Criteria: Female subjects who were pregnant, nursing, or planning to become pregnant during study participation; History of hypersensitivity to the study products or any topical or systemic corticosteroids;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: single-exposure, open-label, vasoconstriction response study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Clocortolone Pivalate Cream, 0.1% | Drug: Clocortolone Pivalate<br>* Cream, 0.1%<br>* Other names: Clocortolone;|
| Active Comparator: Reference<br>Cloderm® (clocortolone pivalate) Cream, 0.1% | Drug: Clocortolone Pivalate<br>* Cream, 0.1%<br>* Other names: Clocortolone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUEC0-24 (area under the effect curve) | value for the blanching intensity vs. time profile | 24 hours |
Data and Sample Collection Study to Elucidate the Mechanisms of Eosinophilic Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to elucidate the mechanisms underlying eosinophil growth, survival, migration, and function and to investigate and further characterize the pathophysiology of, clinical manifestations of, and spectrum of disease severity of eosinophilic inflammation in humans.

Official Title
-----------------
Eosinophils and Inflammation, an Expanded Study

Conditions
-----------------
Eosinophilic Gastrointestinal Disease Eosinophilic Inflammatory Disease, Food Allergy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent obtained from the patient or parent/guardian. Assent will be obtained from all minors 11 years of age and older. Carrying a diagnosis of eosinophilic gastrointestinal disease, eosinophilic inflammatory disease, or food allergy OR family member, or normal control
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
-----------------
Eosinophilic Disorders
Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes

Study Overview
=================
Brief Summary
-----------------
An electronic decision aid will be used to assist individuals in choosing a multi-gene panel with their medical oncologist instead of a genetic counselor. A decision aid may facilitate quality decisions around the selection of a specific multi-gene panel without a genetic counselor. Upon completion of the decision aid, participants will be asked to indicate their decision about whether to pursue genetic testing and which specific multi-gene panel to pursue. A survey will then be administered to assess participants' opinions on the decision aid.

Official Title
-----------------
Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes

Conditions
-----------------
Genetic Testing

Intervention / Treatment
-----------------
* Other: Survey of Decision Aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18 years of age or older) Diagnosed with malignant ovarian tumor or malignant pancreatic adenocarcinoma Exclusion Criteria: Children (<18 years of age) Unable to complete surveys Previous germline genetic testing

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic Decision Aid<br>Participants in this arm will complete an electronic decision aid for genetic testing. | Other: Survey of Decision Aid<br>* The decision aid will be evaluated by a survey administered to those who have used the tool.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant satisfaction with how educational information is presented in the decision aid | Measured with 6 items on a questionnaire that asks participants to rate the way certain information is presented on the decision aid. Each item is rated on a scale of 1 to 4, with 1 being poor and 4 being excellent. | This outcome will be measured immediately following completion of the decision aid | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time spent on decision aid | The total amount of minutes spent on the decision aid | From the start of the decision aid to the completion of the decision aid | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Decision Aid
Fexofenadine in Pruritic Skin Disease

Study Overview
=================
Brief Summary
-----------------
Primary objective: To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease Secondary objective: To evaluate patient's satisfaction of Allegra treatment

Official Title
-----------------
The Evaluation of Efficacy and Safety of Fexofenadine 180mg Tablets for 7 Days in the Treatment of Pruritic Skin Disease

Conditions
-----------------
Pruritus

Intervention / Treatment
-----------------
* Drug: Fexofenadine


Participation Criteria
=================
Eligibility Criteria
-----------------
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional. Main criteria are listed hereafter: Inclusion Criteria: All patients diagnosed with atopic dermatitis, contact dermatitis Exclusion Criteria: Other skin disease except atopic dermatitis, contact dermatitis. Subjects taken steroid within 4 weeks and antihistamine within 1 week before screening day. Pruritus localized only head and face Subjects with severe hepatic, renal, heart dysfunction. Subjects with history of alcohol and drug abuse. Pregnant and lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 12 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of physician's assessment on pruritic score before and after 7-day treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient visual analogue scale change and Overall satisfaction. |  |  |