linjc16/ctgov huggingface dataset:
Physical Activity Intervention in Preschool Children

Study Overview
=================
Brief Summary
-----------------
In this research project, the investigators addressed if incorporating physical movements with preschoolers will help increase their ability to retain concepts learned in preschool such as letter, sound and number recognition. Movement plays an important role in the brain. Exercise shows many benefits for the brain to help maintain clearer thought, improve memory, and increase activity in the brain, especially the areas involved in memory, attention, and language. The following research includes an eight week study of the implementation of movement breaks with one preschool class, while using another class as a control group. During the two weeks of baseline data, data was collected from every student in both groups on their letter recognition with both upper and lower case, letter sound identification, and number recognition for numbers 0-10. The group that implemented movement breaks had three-five minute scheduled times to stop for movement. Data was collected and compared between the two groups to find differences in their academic performance.

Official Title
-----------------
Physical Activity Intervention in Preschool Children

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Behavioral: Physical Activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled preschool student Exclusion Criteria: Enrolled in multiple preschool classes

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Activity<br>5 minute movement breaks | Behavioral: Physical Activity<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity as measured by a Modular Signal Recorder Accelerometer |  | 8 wks | 
| Letter recognition as measured by an Academic Growth Assessment |  | 8 wks | 
| Sound recognition as measured by an Academic Growth Assessment |  | 8 wks | 
| Number recognition as measured by an Academic Growth Assessment |  | 8 wks |
CareTaker Respiratory Rate Detection Study

Study Overview
=================
Brief Summary
-----------------
The goal of the proposed study is to test the capability of the CareTaker monitor to extract the respiration signature from its acquired signal, and to determine a respiration rate of breaths/minute that meets or exceeds the performance levels of its predicate device.

Detailed Description
-----------------
The goal of the proposed study is to test the capability of the CareTaker monitor to extract the respiration signature from its acquired signal, and to determine a respiration rate of breaths/minute that meets or exceeds the performance levels of its predicate device. The detection approach of RSPR (respiratory rate) that the CareTaker technology takes is based on peak detection and pulse analysis of arterial pressure pulse signals, as well as spectral analysis of the raw CareTaker sensor signal. The study was performed under the supervision of the Chesapeake IRB and involved 21 subjects >18 y who were monitored during spontaneous and metronome-paced breathing.

Official Title
-----------------
CareTaker Respiratory Rate Detection Study

Conditions
-----------------
Respiration Rate Detection

Intervention / Treatment
-----------------
* Device: non-intrusive respiration monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years of age, who are able and willing to participate and have given verbal assent Exclusion Criteria: Unable to give written consent <18 years of age No or poor finger pulse, as determined through visual inspection for ischemic hands

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

| Intervention/Treatment |
| --- |
|Device: non-intrusive respiration monitor|Equivalence of CareTaker's respiration rate detection capability to that of predicate device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiration rate detection with accuracy of better than 3 breaths per minute | Comparison with performance of predicate device (accuracy within 3 breaths per minute). | 15 minutes of matched respiration rates | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiration Rate Detection
Pediatric Metabolism and Microbiome Repository

Study Overview
=================
Brief Summary
-----------------
The aim of this project is to establish a bio-repository of diverse specimen types to provide investigators access to specimens in order to further research related to metabolism and the microbiome in the pediatric population.

Detailed Description
-----------------
Human microbial cell lines, stool and/or DNA and RNA will be collected from participants 10-18 years with a BMI greater than 95th percentile and their healthy siblings. Specimens will be collected at 3 time points over a seven month period. Healthy siblings will provide just one blood and stool sample. Samples will be maintained at the Duke Medical Science Research Laboratory.

Official Title
-----------------
Pediatric Metabolism and Microbiome Repository

Conditions
-----------------
Pediatric Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of the Healthy Lifestyles Program at Duke for the care of children with obesity, a sibling of a patient in the Healthy Lifestyles Program, or is a patient at Duke Children's Primary Care. Exclusion Criteria: Pregnant females.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 23 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 |
| --- | --- |
| BMI > 95%<br>No Intervention | |
| Healthy Weight Siblings<br>Control | |
| Healthy Weight Unrelated<br>Control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The measure of abnormal metabolism using a sample biorepository | measures of metabolomics using a sample biorepository | 5 years |
Efficacy and Safety of Zoledronic Acid in Patients With Bone Metastases of Any Solid Tumors or Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
Zoledronic acid is a medication that slows the breakdown of bone. This study will assess the efficacy and safety of zoledronic acid in Chinese patients with multiple myeloma or other solid tumors with bone metastases.

Official Title
-----------------
A Randomized, Double-blind, Multi-centre Study to Evaluate the Fficacy and Safety of Zometa as a Treatment in Patients With Bone Metastases of Any Solid Tumors or Multiple Myeloma

Conditions
-----------------
Treatment of Bone Metastases

Intervention / Treatment
-----------------
* Drug: Zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Cancer patients (multiple myeloma or other solid tumors) and confirmed evidence of bone lesions Significant bone pain Exclusion Criteria Poor renal function Use of other investigational drugs within 30 days of visit 2 Dental or other surgery to the jaw within 6 weeks of screening, or planned during the 4 week study Other protocol-defined exclusion criteria may apply.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zoledronic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare in a randomized fashion the effect of zoledronate and pamidronate 90 mg on pain relief as assessed by pain score after 1-dose treatment in patients with bone pain induced by any solid tumors with bone metastases or Multiple Myeloma |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bone markers (urinary N-telopeptide/creatinine ratio, urinary C-telopeptide/creatinine ratio). |  |  |
An Open-Label, Single-Dose, Mass-Balance Study to Assess the Disposition of 14C-Labeled PRT054021 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
This is a open label, single center, single oral dose, study of PRT054021, in healthy subjects.

Official Title
-----------------
AN OPEN-LABEL, SINGLE-DOSE, MASS-BALANCE STUDY TO ASSESS THE DISPOSITION OF 14C-LABELED PRT054021 IN HEALTHY MALE SUBJECTS

Conditions
-----------------
Health Volunteers

Intervention / Treatment
-----------------
* Drug: Betrixaban single oral dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult men ages of 19 and 55 years old, inclusive weighs at least 132 lbs Exclusion Criteria: Clinically significant comorbid disease History of substance abuse Hemoglobin less than 12.0 g/dl

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm Oral Betrixaban<br> | Drug: Betrixaban single oral dose<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean (max, tmax, AUC) |  | Over 336 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent dose recovered in urine and feces |  | Over 336 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Betrixaban, Healthy, Mass Balance
Tipranavir Expanded Access Program (EAP) in PI-experienced Patients With HIV-1 Infection

Study Overview
=================
Brief Summary
-----------------
This study was designed to provide early access to and evaluate the safety of TPV/r in PI-experienced patients with HIV-1 infection.

Official Title
-----------------
An Open Label, Non-randomized Treatment Protocol of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Protease Inhibitor-experienced Patients With HIV-1 Infection (the Tipranavir Expanded Access Program)

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

Intervention / Treatment
-----------------
* Drug: Tipranavir
* Drug: Ritonavir


Participation Criteria
=================

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tipranavir|500 mg twice daily|
|Drug: Ritonavir|200 mg twice daily|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Double-Blind, Placebo Controlled, Single, Escalating Dose Study to Evaluate the Preliminary Pharmacokinetics, Safety and Tolerability of LNK-754 in Healthy Elderly Volunteers

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the single-dose plasma pharmacokinetics of LNK-754 as well as safety and tolerability in normal healthy male and female elderly volunteers

Official Title
-----------------
A Double-Blind, Placebo Controlled, Single, Escalating Dose Study to Evaluate the Preliminary Pharmacokinetics, Safety and Tolerability of LNK-754 in Healthy Elderly Volunteers

Conditions
-----------------
Healthy Elderly Volunteers

Intervention / Treatment
-----------------
* Drug: LNK-754


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and Females aged 60 to 75 years Good general health as determined by medical history and physical examination Body Mass Index of 18-32, inclusive Estimate of creatinine clearance by Cockcroft-Gault that is normal for age and sex (greater than or equal to 60mL/min) Normal hemoccult test at screening and baseline Voluntarily consent to participate in the study Willing to adhere to the protocol requirements Exclusion Criteria: Subjects with clinically significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, neurological, sleep disorders by DSM-IV criteria, endocrine, hematological, or metabolic disease as determined by medical history and physical examination Subjects who have been diagnosed with or meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV_TR) criteria for any significant psychiatric or psychoactive substance use disorder within the past year Subjects with positive urine drug screen or compounds associated with abuse in the absence of medical justification for their presence QTcB greater than 450 msec (males), or greater than 470 (females), based on the average interval of triplicate ECGs obtained after five minutes rest in a supine position using hte ECG algorithm Clinically significant abnormal screening results or laboratory tests Pregnant or nursing or planning a pregnancy, or planning on fathering a child

Ages Eligible for Study
-----------------
Minimum Age: 60 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

Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LNK-754|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Pharmacokinetics |  | 24 hours |
A Study of Brain Receptor Occupancy in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To measure the occupancy of brain kappa opioid receptors after single oral doses of LY2456302.

Official Title
-----------------
Assessment of Brain Kappa Opioid Receptor Occupancy After Single Oral Doses of LY2456302 as Measured by PET With Radioligand LY2879788 in Healthy Subjects

Conditions
-----------------
Alcohol Dependence

Intervention / Treatment
-----------------
* Drug: opioid receptor kappa antagonist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female Have clinical laboratory tests within normal reference ranges Have arterial and venous access sufficient to allow blood sampling Exclusion Criteria: Currently enrolled in, or discontinued within the last 30 days from a clinical trial History of severe allergies or multiple adverse drug reactions Have an abnormal ECG at screening visit Have abnormal sitting blood pressure Have an increased risk of seizures Current suicidal ideation Positive test for HIV, hepatitis C, or hepatitis B Women who are breast feeding Smoke more than 10 cigarettes per day, or equivalent Drink more than 5 cups of coffee per day, or equivalent Have a history of head injury Unable to undergo a MRI Suffer from claustrophobia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: opioid receptor kappa antagonist<br> | Drug: opioid receptor kappa antagonist<br>* Starting dose of 2 mg, administered orally, once. The potential dose range for this study is 0.2 mg to 30 mg<br>* Other names: LY2456302;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET) |  | Baseline, after single dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics, area under the curve (AUC) |  | Days 1 and 2 | 
| Number of participants with clinically significant effects |  | Baseline to study completion | 
| Pharmacokinetics, concentration maximum (Cmax) |  | Days 1 and 2 |
Comparison of Oral Zaldiar With Intravenous Paracetamol and Tramadol

Study Overview
=================
Brief Summary
-----------------
Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol).

Detailed Description
-----------------
Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. This is the classical approach. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol). This is the new approach.

Official Title
-----------------
ZIH Study : Comparison of Oral Zaldiar (Combination of Paracetamol and Tramadol) With Intravenous Paracetamol and Tramadol for Postoperative Analgesia After Inguinal Hernia Repair

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

Intervention / Treatment
-----------------
* Drug: Zaldiar
* Drug: Paracetamol-Tramadol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients incoming for inguinal hernia repair Exclusion Criteria: Preoperative abuse of analgesics

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Z<br>Postoperative Analgesia with Zaldiar | Drug: Zaldiar<br>* Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)<br>* Other names: Oral Zaldiar;|
| Active Comparator: Group PT<br>Postoperative Analgesia with Paracetamol-Tramadol | Drug: Paracetamol-Tramadol<br>* Postoperative analgesia with intravenous Paracetamol and Tramadol<br>* Other names: Intravenous Paracetamol and Tramadol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Pain | Difference between groups in term of analgesia (as measured by Visual Analog Scale: VAS). The VAS range are between 0 and 10. A worse outcome was defined as VAS > 4. The VAS use units on a scale. | In recovery room |
Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial

Study Overview
=================
Brief Summary
-----------------
To determine whether the use of two antiviral agents in combination will be better than placebo in the treatment of an inflammatory sidease of the spinal cord caused by HTLV-I

Detailed Description
-----------------
Randomised, double-blind, placebo-controlled two centre study of zidvoudine plus lamivudine in HAM/TSP 24 patients randomised 1:1 2-4 week lead-in 6 months randomised phase followed by 6 months open-label therapy with active drug Primary endpoint: clinical Secondary endpoints: virological and immunological

Official Title
-----------------
Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial

Conditions
-----------------
HTLV-I-associated Myelopathy

Intervention / Treatment
-----------------
* Drug: Zidovudine/lamivudine
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HTLV-I-associated myelopathy Exclusion Criteria: prior exposure to zidovudine or lamivudine on disease modifying therapy under age 16

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo in HAM/TSP 24 | Drug: Placebos<br> <br> |
| Active Comparator: Zidvoudine plus lamivudine<br>Zidvoudine plus lamivudine in HAM/TSP 24 | Drug: Zidovudine/lamivudine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed walk | Time taken to walk 13m | 6 months | 
| Osame's Motor Disability Score | 0 - 4 (Unaided walk), 5 - 8 (Needs aid to walk), 9 - 13 (Unable to walk) | 6 months | 
| Pain score | 11 point Visual Analogue Scale 0 = no pain, 10 = worse pain | 6 months | 
| Urinary frequency | Number of times passing urine during the daytime | 6 months | 
| HTLV-1 proviral load | The number of copies of HTLV DNA in 100 peripheral blood mononuclear cells | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD25% | Expression of CD25 on T-cells | 6 months | 
| HLA-DR% | Expression of HLA-DR on T-cells | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HAM/TSP, HTLV-I-associated myelopathy, zidovudine, lamivudine, antiretroviral therapy