linjc16/ctgov huggingface dataset:
Treatment of Insomnia and Glucose Metabolism

Study Overview
=================
Brief Summary
-----------------
Available data suggest that obtaining adequate sleep is associated with a better ability of the body to use carbohydrates as a source of energy and a lower risk of developing diabetes. The sleeping pill, Eszopiclone (Lunesta), has been approved by the Food and Drug Administration for the treatment of people who complain of trouble falling or staying asleep. This study will examine the hypothesis that the use of Eszopiclone (Lunesta) to improve the sleep of people with insomnia may also improve the use of sugar in their body.

Detailed Description
-----------------
Study participants will complete a set of oral and intravenous glucose (sugar) tolerance tests, which will be performed on two separate occasions in random order: once after a week of treatment with Eszopiclone (Lunesta) and once again after a week of receiving placebo.

Official Title
-----------------
Double-blind Placebo-controlled Study of the Effects of Eszopiclone on Glucose Tolerance, Insulin Secretion, and Insulin Action in Adults With Chronic Insomnia

Conditions
-----------------
Sleep, Insomnia, Insulin Resistance

Intervention / Treatment
-----------------
* Drug: Eszopiclone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 35 and 64 must have long-standing trouble falling or staying asleep BMI between 22 and 34 kg/m2 Exclusion Criteria: sleep apnea or other sleep disorder other than insomnia diagnosis of diabetes requiring treatment with pills or insulin smoking night or shift work presence of a medical condition that can disrupt sleep women only: irregular menstrual periods or pregnancy use of medications/compounds that can disrupt sleep

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 64 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Eszopiclone or Placebo<br>Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded. | Drug: Eszopiclone<br>* Eszopiclone 3 mg by mouth daily at bedtime for 9 days<br>* Other names: Lunesta;Drug: Placebo<br>* Placebo by mouth daily at bedtime for 9 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test |  | at the end of each treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep, eszopiclone, insulin secretion, insulin action, glucose tolerance
Assessment of Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
Development of neuropathic pain is one of the most disabling sequels after spinal cord injury (SCI) and in peripheral nerve diseases. The functionality of the pain pathway in humans as well as its plastic changes following SCI can be assessed in vivo by surface electrophysiological recordings and functional magnetic resonance imaging after noxious heat stimulation of the skin. Aims: a) establishing a clinically applicable assessment of the pain pathway and characterizing its changes as a consequence of SCI and in peripheral nerve diseases in an objective manner, b) characterizing plastic changes in the pain pathway in SCI patients with neuropathic pain and in patients with peripheral nerve diseases and relating them to the development of neuropathic pain syndromes.

Conditions
-----------------
Spinal Cord Injury + Peripheral Nerve Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uninjured Scord injured subjects Subjects with peripheral nerve diseases Exclusion Criteria: Presence of any central psychiatric disorder (that precludes subject from giving informed and voluntary consent) For fMRI measurements: yes for any item in the MR-risk questionnaire

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SCI subjects<br>Chronic and traumatic SCI subjects | |
| Healthy control subjects<br> | |
| Subjects with peripheral nerve diseases<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, sensory and autonomic assessments |  | 2 - 4 weeks |
Cereals as a Source of Iron for Breastfed Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine whether the type of iron in infant cereals makes a differance in how well the cereal helps infants remain free of iron deficiency.

Official Title
-----------------
Breast Feeding and Iron: Comparison of Cereals Fortified With Different Forms of Iron

Conditions
-----------------
Iron Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: electrolytic iron
* Dietary Supplement: ferrous fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: exclusively breastfed birth weight between 2500 and 4200g gestational age >36 weeks Exclusion Criteria: supplementing formula no iron drops

Ages Eligible for Study
-----------------
Minimum Age: 28 Days
Maximum Age: 1 Year

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cereal L<br>Rice cereal with electrolytic iron | Dietary Supplement: electrolytic iron<br>* 1/4 a cup of cereal fortified with electrolytic iron per day between the ages of 112 days and 280 days of age<br>|
| Active Comparator: Cereal M<br>Rice cereal with ferrous fumarate | Dietary Supplement: ferrous fumarate<br>* 1/4 cup of cereal fortified with ferrous fumarate to be fed per day between ages of 112 days and 280 days of age<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma ferritin |  | 280 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin |  | 280 |
Study on Optimal Treatment Strategy for Elderly Patients With High-risk Complex Aortic Valve Disease

Study Overview
=================
Brief Summary
-----------------
Aortic valve disease (AVD) is the most common and age-related mortality in elderly patients with valvular heart disease (VHD). Although transcatheter aortic valve replacement (TAVR) has been recommended at a higher level in foreign guidelines, there are still many high-risk and severe elderly patients with VHD who have not received effective treatment because of many complications and untimely medical treatment. Different from Europe and the United States, the majority of patients with bicuspid aortic valve are in China, and the calcification is more serious. The current clinical evaluation system and treatment guidelines can not be effectively applied to the high-risk and complex elderly patients. Therefore, the investigators should train and set up a valvular heart disease team, explore the technical difficulties of TAVR treatment in such patients, establish emergency TAVR operation mechanism, build a clinical evaluation system for high-risk and complex elderly patients with aortic valve disease in China, evaluate the curative effect periodically and further optimize the treatment strategy, so as to improve the quality of life and the meaning of life cycle of elderly patients with VHD in China Great significance.

Official Title
-----------------
Study on Optimal Treatment Strategy for Elderly Patients With High-risk Complex Aortic Valve Disease

Conditions
-----------------
Aortic Valve Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • patients over 75 years old meet one of the following conditions. severe valvular heart disease as defined by echocardiography: aortic stenosis, moderate or above, or valve area ≤1.0cm2, or maximal jet velocity ≥4.0m/sec, or mean pressure gradient ≥40mmHg, aortic regurgitation, moderate or above, or jet width ≥65% of left ventricular outflow tract, or regurgitant volume≥60ml/beat, or regurgitant fraction ≥50%, Exclusion Criteria: • Patients cannot be followed up for any reasons. •Patients have been enrolled in this study

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| all-cause mortality | The primary endpoint of this study is 1 years all-cause mortality all stroke and re-hospitalization (for valve-related decompensation or procedure-related complications) . | 1 year |
Aspergillus-specific PCR Assay in Cerebrospinal Fluid Samples for Detection of Central Nervous System Aspergillosis

Study Overview
=================
Brief Summary
-----------------
Central nervous system (CNS) invasive aspergillosis (IA) is a fatal complication in immunocompromised patients. Confirming the diagnosis is rarely accomplished as invasive procedures are hampered by neutropenia and low platelet count. Cerebrospinal fluid (CSF) cultures or galactomannan (GM) regularly yield negative results thus suggesting the need for improving diagnostics. Therefore the performance of an established Aspergillus-specific nested PCR in CSF samples of immunocompromised patients with suspicion of CNS IA will be evaluated.

Detailed Description
-----------------
Central nervous system (CNS) invasive aspergillosis (IA) is a fatal complication in immunocompromised patients with hematological malignancies. Confirming the diagnosis is rarely accomplished as invasive procedures are impaired by neutropenia and low platelet count. Cerebrospinal fluid (CSF) cultures or galactomannan (GM) regularly yield negative results thus suggesting the need for improving diagnostic tools. Therefore the performance of an established Aspergillus-specific nested PCR assay in CSF samples of immunocompromised patients with suspicion of CNS IA will be evaluated.

Official Title
-----------------
Diagnostic Study on the Performance of an Aspergillus-specific Nested PCR Assay in Cerebrospinal Fluid Samples of Immunocompromised Patients for Detection of Central Nervous System Aspergillosis

Conditions
-----------------
Aspergillosis, Infection in an Immunocompromised Host

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Immunocompromised patients with suspected CNS infection, especially cerebral aspergillosis Exclusion Criteria: proven CNS infections caused by pathogens other than Aspergillus
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 |
| --- | --- | --- |
| Test sensititivity |  | one year |
A Randomized, Controlled Trial of Inspiratory Muscle Training (IMT)in the ICU and CCU

Study Overview
=================
Brief Summary
-----------------
Inspiratory muscle training (IMT) is an intervention used with success in the outpatient setting within the COPD population. Use of IMT is also theoretically possible during mechanical ventilation. This study will will assess the feasibility and safety of the study of IMT in the patient population.

Official Title
-----------------
A Randomized, Controlled Trial of Inspiratory Muscle Training (IMT)in the ICU and CCU

Conditions
-----------------
Critically Ill, Respiratory Failure

Intervention / Treatment
-----------------
* Device: Inspiratory Muscle Trainer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mechanically ventilated patients. Must have passed spontaneuos brething trial screening but failed the trial itself. Potential subject must be able to perform atleast 5 minutes of spontaneous breathing trial. Exclusion Criteria: Known neuromuscular disease Unstable cardiac ischemia Tracheostomized patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMT<br>In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge. | Device: Inspiratory Muscle Trainer<br> <br> |
| Sham Comparator: Sham<br>In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge. | Device: Inspiratory Muscle Trainer<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Feasibility of Inspiratory Muscle Training | The number of patients tolerating Inspiratory Muscle Training or Sham. | Baseline and until participant is extubated or discharged from the critical care unit (up to 1 month post-baseline) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, Critically ill, intubated, feasibility, inspiratory muscle training
Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy

Study Overview
=================
Brief Summary
-----------------
Pregabalin will decrease the total amount of opioid required in patients undergoing total abdominal hysterectomy. In addition, pregabalin will decrease the incidence of opioid-related side effects in patients undergoing total abdominal hysterectomy.

Official Title
-----------------
Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Placebo administration
* Drug: Pregabalin administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA Physical Status 1-2 Age 18-64 BMI 18-35 Scheduled for elective total abdominal hysterectomy (with or without bilateral salpingo-oophorectomy) Gender: Female Consent: Obtained Exclusion Criteria: Patient refusal Allergy to study medication(s) Preoperative use of gabapentinoids Preoperative use of anticonvulsants Daily use of analgesics Hepatic disease Renal insufficiency (Cr >2.0) Alcohol or drug abuse Pregnancy Language: Non-English speaking Patient expected to remain intubated after procedure Dropout: Patient request Surgeon request Allergic reaction to pregabalin Surgical procedure significantly altered from scheduled procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pregabalin administration<br>Administration of pregabalin | Drug: Pregabalin administration<br>* Administration of pregabalin<br>|
| Placebo Comparator: Placebo<br>Administration of placebo | Drug: Placebo administration<br>* Administration of placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total hydromorphone consumption | total hydromorphone consumption 24 hours post operatively | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores postoperative | Post operative pain scores | Post operative period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hysterectomy, Pain, Pregabalin
Effects of Bile Acids on GLP-1 Secretion After Roux-en-Y Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects of bile acids on GLP-1 secretion after Roux-en-Y gastric bypass.

Official Title
-----------------
Effects of Ursodeoxycholic Acid and Chenodeoxycholic Acid on GLP-1 Secretion After Roux-en-Y Gastric Bypass

Conditions
-----------------
Severe Obesity

Intervention / Treatment
-----------------
* Other: Water
* Drug: Ursodeoxycholic Acid
* Drug: Chenodeoxycholic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uncomplicated RYGB performed minimum 3 months prior to the study. Fasting plasma glucose < 7.0mM, HbA1c < 48mmol/mol 3 months after RYGB. Exclusion Criteria: Fasting plasma glucose > 7.0mM, HbA1c > 48mmol/mol 3 months after RYGB. Dysregulated hypothyroidism, use of antithyroid treatment. Late diabetic complications as retinopathy, renal insufficiency, neuropathy or previous pancreatitis. Complications to RYGB: Documented reactive hypoglycaemia, severe dumping (vomiting, diarrhea, severe abdominal pain after food intake).
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br>150mL water | Other: Water<br> <br> |
| Experimental: Ursodeoxycholic acid<br>Ursodeoxycholic acid (750mg) dissolved in 150mL water | Drug: Ursodeoxycholic Acid<br> <br> |
| Experimental: Chenodeoxycholic acid<br>Chenodeoxycholic acid (1250mg) dissolved in 150mL water | Drug: Chenodeoxycholic Acid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GLP-1 secretion (evaluated by iAUC) |  | Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-peptide secretion (evaluated by iAUC) |  | Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 | 
| PYY secretion (evaluated by iAUC) |  | Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 | 
| Glucagon secretion (evaluated by iAUC) |  | Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 | 
| GIP secretion (evaluated by iAUC) |  | Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 | 
| CCK secretion (evaluated by iAUC) |  | Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 | 
| Gherlin secretion (evaluated by iAUC) |  | Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 | 
| Changes in bile acids/FGF-19 |  | Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 | 
| TSH/T3/T4 |  | 0, 60, 120, 180 | 
| Appetite measurements (VAS-score) |  | Baseline, 30, 60, 120, 180 |
ALFAsleep: Exploring Cognitive and Biological Correlates of Sleep Quality and Their Potential Links With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The main goal of this study is to perform a multimodal characterization of brain structural and functional changes, as well as changes in Alzheimer's disease (AD) biomarkers, as a function of sleep quality measures. Cross-sectional data will enable us to confirm and expand previous knowledge in a large and well-phenotyped population, while longitudinal data will allow us to test the hypothesis of the existence of a bidirectional relationship between sleep quality and AD.

Detailed Description
-----------------
The main goal of this study is to perform a multimodal characterization of brain structural and functional changes, as well as changes in Alzheimer's disease (AD) biomarkers, as a function of sleep quality measures. Cross-sectional data will enable us to confirm and expand previous knowledge in a large and well-phenotyped population, while longitudinal data will allow us to test the hypothesis of the existence of a bidirectional relationship between sleep quality and AD.

Official Title
-----------------
ALFAsleep: Exploring Cognitive and Biological Correlates of Sleep Quality and Their Potential Links With Alzheimer's Disease

Conditions
-----------------
Cognitively Unimpaied

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects that are currently participating in the ALFA+ study (cognitively healthy adults aged between 45-65 years at the moment of the inclusion in the 45-65/FPM2012 study). Subjects from whom CSF and/or neuroimaging biomarkers have been acquired during the last 36 months prior to their enrollment in the current study. Exclusion Criteria: Presence of cognitive impairment. Presence of clinically relevant neurological disorder, psychiatric disorder or other medical conditions that may jeopardize the interpretation of the study results according to the investigator criteria For the PSG sub-study, participants currently treated with drugs that may interfere in PSG data interpretation (e.g. antidepressants or benzodiazepines).

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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 |
| --- | --- | --- |
| Sleep quality | Actigraphy-derived sleep quality measures | up to 2 weeks |