linjc16/ctgov huggingface dataset:
Study of the Role of Soluble Inhibitor of Interleukin 22, Interleukin 22 Binding Protein (IL-22BP), in Chronic Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
IL-22 is an IL-10 family cytokine that plays major actions to increase intestinal epithelial barrier function and regeneration during experimental colitis. IL-22 binding protein is a small, soluble, and secreted protein potently inhibiting IL-22 actions through preventing the binding with IL-22 Recepteur. This study aims at characterizing how IL-22 binding protein is regulated in Inflammatory bowel disease to better understand the way IL-22 acts on epithelial cells during flares of the disease.

Conditions
-----------------
Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Other: Non interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Crohn's disease or Ulcerative colitis Healthy controls paired for age and sex Samples availability in the biobank Signed consent No (Immune Mediated Inflammatory Disorders other than Inflammatory bowel disease No other conditions predicted or known to affect IL-22/IL-22 recepteur /IL-22 binding protein regulation Availability of clinical data Age >18 y.o. No pregnancy

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non interventional study|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regulation of Interleukine 22 binding protein expression in Crohn's disease or Ulcerative colitis |  | 1 day |
Pediatric Locking Nail for the Treatment of Femoral Fractures in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this multi-center prospective clinical outcomes study is to determine validity and safety of the pediatric locking nail for femoral fracture management in children with open physes.

Official Title
-----------------
A Prospective Multi-Center Clinical Outcomes Study To Assess The Safety and Effectiveness Of The Pediatric Locking Nail For Treatment Of Femoral Fractures In Children

Conditions
-----------------
Femur Fracture

Intervention / Treatment
-----------------
* Device: Pediatric Locking Nail


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject, representative willing to sign informed consent. Ability and willingness of the subject to follow postoperative care instructions until healing is complete Subject age must be between 8-16 inclusive. Subjects with a minimal canal diameter of 9mm or greater And any of the following fracture types Non-comminuted and comminuted mid-shaft fractures Distal third fractures 4 cm above the distal physis Fractures that are open or closed Subtrochanteric fractures Exclusion Criteria: A subject has a bone or soft tissue infection. Subject has a systemic infection. Subject has a distal (supracondylar) fracture. Subject with pathological bone (osteogenesis imperfecta and other conditions resulting in abnormal bone quality). Subjects with mental or neurological condition who are unwilling or incapable of following postoperative care instructions. Subject with conditions including blood supply limitation, and insufficient quantity or quality of bone. Foreign body sensitivity, where material sensitivity is suspected, testing is to be completed prior to implantation of device if at all practical or the subject should be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 16 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>The Pediatric Locking Nail was designed to provide stable sub-rigid fixation of femoral fractures in children | Device: Pediatric Locking Nail<br>* The nail is pre contoured with a nine-degree anterior bow and is universal for right and left femoral.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| limb alignment |  | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of healing, weight-bearing time (time to full weight bearing), and length of hospital stay and absence of complications |  | 48 Months |
Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effectiveness of as needed versus fixed dosing of an investigational medication for women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.

Official Title
-----------------
A 12-Week, Randomized, Double-Blind, Placebo- Controlled Study of PRN BID and Fixed Dosing Regimens of Alosetron in Female Subjects With Severe Diarrhea-Predominant Irritable Bowel Syndrome Who Have Failed Conventional Therapy

Conditions
-----------------
Irritable Colon, Irritable Bowel Syndrome (IBS)

Intervention / Treatment
-----------------
* Drug: alosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS). Failed conventional therapy. Willing to make daily calls on a touch-tone telephone. Exclusion criteria: History of or current chronic or severe constipation. Bloody diarrhea, abdominal pain with rectal bleeding. Thrombophlebitis. Abnormal thyroid stimulating hormone (TSH) value. Alcohol and/or substance abuse within past two years. Pregnant or lactating. History/treatment of malignancy within past five years.

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

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

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: alosetron|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject self assessment of improvement between treatment groups using the IBS Global Improvement Scale; comparison of safety and tolerability between treatment groups with respect to adverse events & laboratory abnormalities. |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of treatment groups with respect to subject relief of IBS pain & discomfort; lower GI symptoms, changes in quality of life, lost workplace productivity, & lost household/leisure activity, & subject satisfaction with assigned study drug. |  | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PRN, Diarrhea-Predominant Irritable Bowel Syndrome, Irritable Bowel Syndrome (IBS)
The Use of the Internet to Facilitate Weight Loss and Maintenance.

Study Overview
=================
Brief Summary
-----------------
This project is assessing the effectiveness of using the Internet as a tool to facilitate the maintenance of weight lost in a behavioral weight control program. Participants attend a standard behavioral weight control intervention via Interactive Television and after 6 months are randomly assigned to one of three groups; a control group, an in-person weight maintenance group and a maintenance group that meets over the Internet. This research project is being conducted in Vermont.

Official Title
-----------------
The Use of the Internet to Facilitate Weight Loss and Maintenance.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Behavioral weight loss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 25 and 39.9 Internet connection Exclusion Criteria: Major medical problems Inability to walk for exercise

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavioral weight loss|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Behavioral weight control, Internet
Vitamin K and Bone Turnover in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
This one year study of the K vitamers phylloquinone (K1) and menatetranone (MK4) will study supplementation effects on bone turnover and bone density. Women at least 5 years postmenopause with normal bone density who do not use estrogen therapy or the following medications may be eligible: alendronate (Fosamax), risedronate (Actonel), pamidronate (Aredia), etidronate (Didronel), zoledronate (Zometa), teriparatide (Forteo), raloxifene (Evista), tamoxifene, warfarin (Coumadin), anti-seizure medications, prednisone, or oral steroids. Eligible subjects will take calcium and vitamin D (Citracal) twice a day for the first two months and through-out the study. After the first two months, subjects are randomized to the K1, MK4 or placebo groups. Return visits occur at 1, 3, 6 and 12 months. Fasting blood and urine is collected at each visit and bone density is performed at 3 study visits.

Official Title
-----------------
Vitamin K and Bone Turnover in Postmenopausal Women

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: phylloquinone (K1)
* Drug: menatetranone (MK4)


Participation Criteria
=================
Eligibility Criteria
-----------------
Female, 5 years postmenopause. Ambulatory. Community dwelling. Able to ingest calcium and vitamin D supplements. Willing to restrict vitamin K intake. Stable thyroid dose if appropriate. No history of hyperthyroidism, hyperparathyroidism or other metabolic bone diseases. Absence of hardware in hip and spine. History of malignancy within the last five years. Not currently using coumadin or warfarin. Vitamin D supplements must be less than 800 IU daily. Have not used estrogen or other bone-altering medications (see list in study description) within the last year. No history of liver disease or malabsorption. No known allergy to vitamin K. Have not participated in an investigational drug trial within the last month.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: phylloquinone (K1)|nan|
|Drug: menatetranone (MK4)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopause, Vitamin K, Bone turnover, Bone Density
Genetics of Interstitial Cystitis

Study Overview
=================
Brief Summary
-----------------
The cause of interstitial cystitis is unknown. However, it tends to run in some families suggesting that there may be a genetic susceptibility to the disease. For instance, the disease is found 17 times more commonly in first-degree relatives (parent, sibling, or child) of patients with interstitial cystitis than in the general population. Furthermore, if one twin has interstitial cystitis, the disease is much more common in identical co-twins than fraternal co-twins. This evidence suggests that, in some families, genes that make a person susceptible to interstitial cystitis are being passed from one generation to the next. The University of Maryland School of Medicine and the National Institutes of Health are performing a study to identify these genes for susceptibility for interstitial cystitis. This study is entitled the Maryland Genetics of Interstitial Cystitis (MaGIC) study. The MaGIC study will investigate several hundred families with two or more blood relatives with interstitial cystitis. The study will seek to find changes in genes that are found far more commonly in family members who have interstitial cystitis than in those who do not have the disease.Identifying these genes should lead to a better understanding of the cause of interstitial cystitis. Finding the cause is the first step to finding the cure. This is a national study which is conducted by telephone and mail, and in which you can participate entirely from your home.

Official Title
-----------------
Maryland Genetics of Interstitial Cystitis (MaGIC)

Conditions
-----------------
Interstitial Cystitis, Painful Bladder Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have interstitial cystitis, or painful bladder syndrome. Have at least one blood relative with interstitial cystitis, painful bladder syndrome, or urinary symptoms similar to yours. Are 13 years of age or older. Are available for a telephone, mail, or website interview. Live in the USA or Canada. Exclusion Criteria: Are less than 13 years of age. Have Parkinson's disease, Multiple Sclerosis, Spina bifida, or another neurologic disease that preceeded your interstitial cystitis symptoms

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interstitial Cystitis, Painful Bladder Syndrome, Genetics, Risk factors, Family history
Intranasal Midazolam for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety Using sipNose Device - a Randomized Controlled Study

Study Overview
=================
Brief Summary
-----------------
A Three-arm, Randomized Controlled Trial for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety: Intranasal Midazolam by SipNose versus MAD Versus oral administration

Official Title
-----------------
Intranasal Midazolam for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety Using sipNose Device - a Randomized Controlled Study

Conditions
-----------------
Procedural Sedation, Intra-nasal Delevery Device

Intervention / Treatment
-----------------
* Device: Sipnose device
* Device: MAD (Mucosal Atomization Device)
* Drug: midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: every child >1y who is intended for medical procedure in the emrgency room(suce as: IV insertion, blood sample collection, urinary catether insertion, laceration repair Exclusion Criteria: ASA>2 Active respiratory infection systemic illness Allergy to Midazolam

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal Midazolam by SipNose device<br> | Device: Sipnose device<br>* SipNose's intranasal drug delivery platform uses an innovative mechanism that is suposed to improves efficacy, patient compliance and safety<br>|
| Active Comparator: Intranasal Midazolam by MAD (Mucosal Atomization Device)<br> | Device: MAD (Mucosal Atomization Device)<br>* MAD (Mucosal Atomization Device)<br>|
| Active Comparator: oral administration of midazolam<br> | Drug: midazolam<br>* oral administration of midazolam<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anexiety level | measured by modified PREOPERATIVE ANXIETY SCALE (YALE) | within 60 minute | 
| Sedation level | measured by RAMSAY SEDATION SCALE | within 60 minute |
Web-based Genetic Research on Lupus

Study Overview
=================
Brief Summary
-----------------
The goal of this new lupus research study is two-fold: first, to understand the genetic associations found between people's DNA and this disease, and second, to apply this understanding to drug development efforts with the investigator's partners at Pfizer.

Detailed Description
-----------------
Lupus is a difficult disease to diagnose and one that's difficult to manage, given the lack of specific medicines to treat lupus and the side-effects of current medications. The investigators believe genetics may play a critical role in developing better lupus diagnoses and treatments. If individuals are eligible to participate, the investigators will send a 23andMe DNA saliva kit at no cost. Participants will be asked to take a 15 minute online survey with questions about their lupus experience, symptoms and response to treatments, in addition to five additional bi-monthly short surveys and one final study survey during the 12-month participation. Learn more and join the lupus study today: https://www.23andme.com/lupus/

Conditions
-----------------
Systemic Lupus Erythematosus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with lupus by a qualified physician. consents to have 23andMe (via a partner) contact the physician to obtain medical record information willing to submit a saliva sample for DNA testing and complete online surveys related to condition at least 6 years old (minors under 18 require parental consent to enroll) access to the internet resides in the United States Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lupus patients<br>People diagnosed with Systemic Lupus Erythematosus by a physician | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary DNA sample for genetic analysis |  | 12 months | 
| Online survey | Questions about lupus experience, symptoms and response to treatment | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lupus, Systemic Lupus Erythematosus (SLE), genetic, online, genome wide association, systemic lupus erythematosus, genome wide association study (GWAS)
Long-term Effects of COVID-19 in Adolescents

Study Overview
=================
Brief Summary
-----------------
The overarching objective for this prospective cohort study of COVID-19 in adolescents is to study the long-term effects, with particular emphasis on post-infectious chronic fatigue. A total of 500 individuals with a SARS-CoV-2 positive test will be enrolled in the acute phase of COVID-19 and followed for 6 months. A total of 100 individuals with SARS-CoV-2 negative test will be included during the same time period as a control group. Investigations include autonomic, pulmonary and cognitive assessement; a questionnaire charting symptoms, emotionality, personality, loneliness, life events and demographics; and extensive biobanking including genetic markers, viable PBMC, urine, feces and hair. A subgroup of 40 SARS-CoV-2 positive and 20 SARS-CoV-2 negative individuals will also undergo detailed cardiological examination by echocardiography. Primary endpoints are fatigue at 6 months as assessed by the Chalder Fatigue Scale and post-COVID-19 syndrome cases at 6 months according to the WHO definition

Official Title
-----------------
Long-term Effects of COVID-19 in Adolescents

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: No active intervention (observational only)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive SARS-CoV-2 test/negative SARS-CoV-2 test Age 12 - 25 years Living in the counties of Oslo or Viken, Norway < 28 days since onset of first symptom Exclusion Criteria: Hospitalised due to COVID-19 Pregnancy Lack of consent

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 25 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SARS-CoV-2 positive<br> | Other: No active intervention (observational only)<br>* No active intervention (observational only)<br>|
| SARS-CoV-2 negative<br> | Other: No active intervention (observational only)<br>* No active intervention (observational only)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Total sum score on the Chalder Fatigue Scale (range 0 - 33, lower scores means less fatigue, ie. better outcome) | 6 months follow-up | 
| Post-COVID-19 syndrome caseness | Post-COVID-19 syndrome casesness according to the WHO definition (issued Sept. 2021; hence, this endpoint was added during the course of the study, but prior to database lock.) | 6 months follow-up |