linjc16/ctgov huggingface dataset:
Intra-Articular, Single-shot Injection of Hyaluronic Acid and Corticosteroids in Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The aim of present study is to to investigate whether the combined injection of HA and CS was superior than HA alone in the treatment of knee OA.

Detailed Description
-----------------
Intra-articular injection of hyaluronic acid (HA) or corticosteroids (CS) has been widely used with debate on its efficacy in osteoarthritis (OA). The aim of present study is to to investigate whether the combined injection of HA and CS is superior than HA alone in the treatment of knee OA.

Official Title
-----------------
Intra-Articular, Single-shot Injection of Hyaluronic Acid and Corticosteroids in Knee Osteoarthritis

Conditions
-----------------
Osteoarthritis, Pain Syndrome, Intra-articular Injection

Intervention / Treatment
-----------------
* Drug: hyaluronic acid
* Drug: hyaluronic acid and corticosteroids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: According to radiographic findings, patients who are suffering from knee OA for over 3 months have to be stage II-IV according to the Kellgren-Lawrence (KL) grade by a senior radiologist. The diagnosis of symptomatic knee OA is based on American Rheumatism Association classification criteria for knee osteoarthritis. Exclusion Criteria: Exclusion criteria are the diagnosis of rheumatoid arthritis or other inflammatory OA, presence of trauma or pain-causing diseases, treatment with oral medications in recent 3 days, physiotherapy and intra-articular injection of HA or CS in the past 6 months. Participants who are allergic to any of the medications used in this study or diagnosed with current systemic infection are also excluded.

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HA & CS group<br>hyaluronic acid and corticosteroids | Drug: hyaluronic acid and corticosteroids<br>* intra-Articular injection<br>* Other names: HA and CS;|
| Experimental: HA group<br>hyaluronic acid | Drug: hyaluronic acid<br>* intra-Articular injection<br>* Other names: HA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | Visual analog scale | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC | Western Ontario and McMaster University Osteoarthritis Index | 6 months | 
| Knee flexion motion | Knee flexion motion | 6 months |
Temporal Discounting Delayed Outcomes on Opioid-Dependent Outpatients - 20

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the degree in which opioid-dependent outpatients discount the value of an additional maintenance dose of buprenorphine under differing states of opioid deprivation.

Official Title
-----------------
Temporal Discounting Delayed Outcomes on Opioid-Dependent Outpatients

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 47 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Money choice |  |  | 
| Heroin craving |  |  |
Investigating Racing Thoughts in Patients With Insomnia Disorder

Study Overview
=================
Brief Summary
-----------------
Cognitive arousal has been identified as playing a key role in the inability to fall asleep or stay asleep. However, although people with insomnia frequently complain about racing thoughts appearing as soon as they get into bed, studies focusing on racing thoughts in insomnia are lacking. The aim of the present study is to investigate racing thoughts in insomnia disorder using a self-report questionnaire, the Racing and Crowded Thoughts Questionnaire. Specifically, the researchers seek to address three related goals: the comparison of RCTQ scores in adults with primary insomnia, healthy individuals, and patients with bipolar disorder in a manic/hypomanic episode; the variation of RCTQ scores relative to time of day; and the specific contribution of racing thoughts to insomnia severity, as compared to worry and rumination.

Official Title
-----------------
Cognitive Hyperarousal in Insomnia Disorder

Conditions
-----------------
Insomnia Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major subject from 18 to 70 years old) with a diagnosis of chronic primary insomnia according to the criteria of ICSD-3 Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research Exclusion Criteria: Subject having expressed opposition to participating in the study Subject under guardianship or guardianship Subject under safeguard of justice Patient with secondary insomnia (OSA, circadian rhythm disorder, severe restless legs syndrome, bipolar disorder, ADD +/- H) Subject under psychotropic treatment other than hypnotics Incomplete data concerning the main endpoint

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A retrospective evaluation of self-reported tachypsychia in primary insomnia |  | Files analysed retrospectively from Jun 01, 2014 to March 13, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insomnia, Hyperarousal, Rumination, Racing thoughts
Food Choice, Psychological Bias, and Genetic Predisposition

Study Overview
=================
Brief Summary
-----------------
This project aims to assess if food choice is impacted by loss aversion (LA), and if this differs based on genetic predisposition to LA, in a UK healthy cohort.

Detailed Description
-----------------
Food choice, defined as how individuals decide on what to buy and eat, involves the acceptance and rejection of specific foods. Food customisation is becoming more common amongst food retailers, allowing customers to alter their meals to their preferences by removing or adding items. Today, food choice is viewed as more complex, food choices are not just dictated by taste but nutritional quality, allergens, and habits. For example, the framework provided for food customisation (e.g. pizza with toppings or a build you own pizza) and the perceived 'healthiness' of food items (e.g. the pizza toppings) can alter food choice. Psychological reasoning, the process by which humans make decisions by drawing conclusions can play a role in food choice; however, humans can possess a psychological bias leading to illogical decision making. Genetics can too play a role in decision making resulting in predetermined influence on food choice. This research wishes to determine if individual's genetics can affect their food choices by researching psychological biases to food choices.

Official Title
-----------------
Food Choice, Psychological Bias, and Genetic Predisposition

Conditions
-----------------
Food Preferences, Genetic Predisposition, Psychological

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy (no known health condition) 18 + years of age UK based Exclusion Criteria: Vegetarian Vegan Other dietary pattern that restricts the consumption of animal products

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy UK adults<br>Healthy UK adults | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of food items remaining | Number of food items added/removed from each decision frame | December 2021 | 
| Frequency of healthy and unhealthy items remaining | Number of healthy and unhealthy food items added/removed from each decision frame | December 2021 | 
| Loss aversion score |  | December 2021 | 
| Genotype: BDNF Val/Met (rs6265), and DRD2 ANNKK1 Taq1a/ANKK1 (rs1800497) |  | December 2021 |
Assessment of Urinary NGAL to Predict AKI in Children Receiving Multiple Nephrotoxic Medications

Study Overview
=================
Brief Summary
-----------------
Nephrotoxic medication (NTMx) exposure is one of the most commonly cited causes of acute kidney injury (AKI) in hospitalized children, and is the primary cause of AKI in 16% of cases. Through initial work at Cincinnati Children's Medical Center, NTMx exposure was found to be potentially modifiable and the associated AKI is an avoidable adverse safety event. Currently, only serum Creatinine monitoring is available to monitor for NTMx-associated AKI. The hypotheses of this NINJA NGAL study are that (1) urine NGAL is highly sensitive to detect NTMx-associated AKI, and (2) Bedside test of urine from high risk NTMx-exposed patients are adequate and reliable compared to urine NGAL measured from the clinical platform.

Official Title
-----------------
Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin to Predict Acute Kidney Injury in Children Research Multiple Nephrotoxic Medications

Conditions
-----------------
Acute Kidney Injury, Nephrotoxicity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving 3 or more nephrotoxic medications on the same day OR Receiving 3 or more days of an intravenous aminoglycoside or vancomycin Exclusion Criteria: Currently being treated for a urinary tract infection Presence of an acute kidney injury prior to enrollment
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 |
| --- | --- | --- |
| Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL | AKI, defined as a 50% rise in serum Creatinine over baseline or a 0.3 mg/dL rise within 48 hours, will be first detected by a rise in Urinary NGAL | 9 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point of Care NGAL Reliability Compared to Clinical Urinary NGAL | A POC urinary NGAL will be determined from a colorimetric assay that determines risk of AKI, which will later be compared to NGAL values from the clinical assay | 7 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AKI, NGAL
Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety and tolerability of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain.

Official Title
-----------------
An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy of Numorphan® CR (Oxymorphone HCL Controlled Release) in Subjects With Cancer Pain or Chronic Lower Back Pain.

Conditions
-----------------
Cancers, Pain, Lower Back Pain

Intervention / Treatment
-----------------
* Drug: Oxymorphone ER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject enrolled in this study must have been previously randomized and dosed in the double-blind treatment period of study EN3202-016 or EN3202-019 and completed the exit visits for these studies. Males or females, age 18 and 75 years, inclusively. The subject continues to have chronic moderate to severe back or cancer pain that requires opioid medication. Women must continue to be of non-childbearing potential. Exclusion Criteria: The subject experienced any serious drug related adverse events in studies EN3202-016 or EN3202-019. The subject withdrew from EN3202-016 or EN3202-019 for a reason other than lack of efficacy. Subjects with known allergies to opiate-class narcotic agents (morphine, codeine, hydrocodone, propoxyphene, meperidine, oxycodone, etc.) or naproxen, or subjects who have any medical condition in which opiates are medically contraindicated.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxymorphone ER<br> | Drug: Oxymorphone ER<br>* Open label<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monthly assessments of pain with the Brief Pain Inventory (BPI) questionnaire, recall of average pain relief, total rescue medication usage and subject's and physician's global assessment of oxymorphone ER |  | 1 year study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate long-term efficacy of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain |  | 1 year study |
Therapeutic Antibodies Against Prion Diseases From PRNP Mutation Carriers

Study Overview
=================
Brief Summary
-----------------
The human Prion diseases can be classified into sporadic, acquired and inherited forms. Inherited forms usually manifest in higher age so there have to be factors preventing Prion propagation in young mutation carriers. Antibodies against the flexible tail of Prions have been shown to be protective in mice. The investigators intend to screen mutation carriers and controls for the presence of Prion autoantibodies.

Official Title
-----------------
Therapeutic Antibodies Against Prion Diseases From PRNP Mutation Carriers

Conditions
-----------------
Prion Diseases

Intervention / Treatment
-----------------
* Other: blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relatives of patients of genetic Prion diseases Obtained informed consent Exclusion Criteria: No informed consent

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 99 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 |
| --- | --- |
| carriers of a mutation in the Prion gene<br>Carriers of a mutation in the Prion gene who are either symptomatic or pre-symptomatic and who do either know or not know their mutation status. | Other: blood draw<br> <br> |
| family members of carriers of a mutation in the Prion gene<br>Relatives of confirmed PrP mutation carriers who carry two wild type alleles. | Other: blood draw<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Prion protein autoantibody levels |  | Baseline, up to 90 years |
Muscle Quality, Fall Concern and Lower Extremity Functionality in Older Women

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to investigate the effects of muscle quality on fear of fall, and lower extremity functionality in older women. The differences between muscle quality, fear of falling and lower extremity functionality in the elderly male and female participating in the study were investigated. Older women had worse muscle quality, higher fall concern and less lower extremity functionality than older men.

Detailed Description
-----------------
The effects of muscle quality and lower extremity functionality, and fear of falling in older women are not well-known compared to older men in the same age group. The aim of the study was to investigate the effects of muscle quality on lower extremity functionality and fear of falling in older women. 168 age-matched older adults participated in the study. The muscle quality Index, fear of fall, and lower extremity functionality were evaluated. The results of older women and men were compared.

Official Title
-----------------
Does Poor Muscle Quality in Older Women Affect Fall Concern and Lower Extremity Functionality?

Conditions
-----------------
Old Age; Debility, Age-Related Sarcopenia

Intervention / Treatment
-----------------
* Other: Muscle Quality Index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being 65 years old or older Having no neurological, orthopedic, communicational, Mental disability that affects the evaluations. Exclusion Criteria: Incomplete data and older adults not agreeing to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Muscle Quality Index|Evaluations are applied to older adults to compare the results of muscle quality.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Quality Index | Muscle Quality Index scored is calculated through anthropometric measurements of older adults. The muscle quality depends on the formula as follows: MQI (Watts) = ((Leg length×0.4)×Body mass×gravity ×10)/ Five Times Sit To Stand. | 6 months | 
| Lower Extremity Functional Scale | LEFS presents 20 questions about daily living activities. The questionnaire was developed to assess lower extremity functionality and can be used in older adults.The minimum and maximum total score ranges from 0 to 80. High scores show high functional status. | 6 months | 
| International Fall Efficiency Scale | The scale consist of items about fall concern during daily living activities. The minimum and maximum total score ranges from 16 to 64. High scores represents high fall concern. | 6 months |
Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Treatment-Withdrawal Study of the Efficacy and Safety of Pantoprazole Sodium Enteric-Coated Granules in Infants (1 Through 11 Months) With Symptomatic GERD.

Conditions
-----------------
Gastroesophageal Reflux

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: term or post term infants beyond the neonatal period of an age greater than 28 days but less than or equal to 11 months clinical diagnosis of GERD weight greater than 2.5 kg and less than or equal to 15 kg Exclusion Criteria: known history of upper GI anatomic disorders history of acute life-threatening medical conditions clinically significant medical conditions or laboratory abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 28 Days
Maximum Age: 11 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pantoprazole<br> | Drug: pantoprazole<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Withdrawn From Study Due to Lack of Efficacy. | Lack of efficacy defined as 1 or more of the following occurring during the double blind treatment-withdrawal phase: significant worsening of gastroesophageal reflux disease (GERD) symptoms frequency, a diagnostic test (e.g., endoscopy) demonstrating worsening of esophagitis, maximal antacid intake for ≥ 7 continuous days, or severe GERD symptoms based on physician's judgment. | 4 weeks double-blind | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, Infants, Gastroesophageal Reflux