linjc16/ctgov huggingface dataset:
Effect of Anti-inflammatory (ITIS) Diet in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
to study the effect of anti-inflammatory diet on clinical and biological outcomes in rheumatoid arthritis

Detailed Description
-----------------
The investigators would like to evaluate how inflammation occurs in the joints of subjects with arthritis, and identify molecules and bacteria that can predict whether a rheumatic subject will flare. Blood, urine and stool will be evaluated in the laboratory and compared to their own samples after changes in diet. This is an exploratory study, which is meant to gather preliminary data about the quick effects of changes in diet and treatment on molecules in blood/urine and bacteria in stools. These studies can provide clues to the cause of disease and might ultimately lead to new therapies.

Official Title
-----------------
Effect of Anti-inflammatory (ITIS) Diet in Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis, Osteoarthritis

Intervention / Treatment
-----------------
* Dietary Supplement: ITIS diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed of rheumatoid arthritis without changes in treatment in the last 3 months Exclusion Criteria: food allergies 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITIS diet<br>anti-inflammatory (ITIS) diet for 14 days | Dietary Supplement: ITIS diet<br>* anti-inflammatory diet for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of baseline pain measured by visual analogue scale (0-10) after two weeks of ITIS diet | Change of baseline pain measured by visual analogue scale after two weeks of ITIS diet, being 0 no pain, and 10 worse pain | 2 weeks |
Different Clinicopathological Features of Non-Elderly Sigmoid Volvulus Patients

Study Overview
=================
Brief Summary
-----------------
Sigmoid volvulus is frequently seen in male patients over 60 years old. In the sigmoid volvulus <60 age groups, the male/female ratio is close to each other. If sigmoid volvulus develops in <60 age groups, it is more likely to be another underlying organic pathology.

Detailed Description
-----------------
Sigmoid volvulus is frequently seen in male patients over 60 years old. Here, the investigators aimed to investigate the causes of sigmoid volvulus developing in patients under 60 years of age. Patients diagnosed with sigmoid volvulus between 2009 and 2018 were retrospectively screened. The patients were divided into two as under 60 years old and above. The co-morbidity, mortality, morbidity, complications, age and gender data of the patients were analyzed. In the sigmoid volvulus <60 age groups, the male/female ratio is close to each other. If sigmoid volvulus develops in <60 age groups, it is more likely to be another underlying organic pathology.

Official Title
-----------------
Different Clinicopathological Features of Non-Elderly Sigmoid Volvulus Patients

Conditions
-----------------
Pathology

Intervention / Treatment
-----------------
* Other: Reasons


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sigmoid volvulus patients under the age of 60 Sigmoid volvulus patients at the age of ≥60 Exclusion Criteria: Lack of data
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elderly patients<br>Elderly patients (60≤ age) with sigmoid volvulus | Other: Reasons<br>* Causes of sigmoid volvulus<br>|
| Young patients<br>Young patients (<60 age) with sigmoid volvulus | Other: Reasons<br>* Causes of sigmoid volvulus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Elderly and young patients mortality | up to three months | 
| Morbidity | Elderly and young patients morbidity | up to three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dolichocolon, volvulus, sigmoid, Parkinson, mental retardation, Hirschsprung's disease
Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder)

Study Overview
=================
Brief Summary
-----------------
The objectives of this survey was to retrospectively collect and evaluate the information on the efficacy and safety of PAXIL tablets (PAXIL, hereinafter) in pediatric subjects (aged under 18) with panic disorder under conditions of actual use.

Official Title
-----------------
Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder)

Conditions
-----------------
Panic Disorder

Intervention / Treatment
-----------------
* Drug: Paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged under 18 at the time of the panic disorder diagnosis Aged under 18 on the starting day of PAXIL treatment Having been making periodic visits to the hospital to receive treatment for panic disorder Exclusion Criteria: Subjects who have been treated with paroxetine prior to this investigation Subjects with hypersensitivity to paroxetine Subjects taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs Concomitant use in patients taking pimozide

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects prescribed PAXIL<br>Pediatric subjects with panic disorder prescribed PAXIL during study period | Drug: Paroxetine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events in Japanese pediatric subjects with panic disorder treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice |  | From the starting day of the treatment to the time of treatment termination/discontinuation was assessed from 1 month at minimum up to 2 years | 
| Efficacy evaluation based on overall improvement |  | From the starting day of the treatment to the time of treatment termination/discontinuation was assessed from 1 month at minimum up to 2 years |
Observational Study on Changing the Quality of Life in Daily Life Activities After Clinical Approach Positioning the Wheelchair

Study Overview
=================
Brief Summary
-----------------
Stemming from the common practice of attribution of the technical helps in the posture in Canada, the multidisciplinary approach of positioning develops in France for more than 10 years old. To date, no observatory study was led to estimate the impact of such consultation in daily activities, an essential objective conditioning the observance and the acceptance of assistive devices. This study wants to estimate the impact through modification of WHOM scale.

Conditions
-----------------
Mobility Limitation, Wheelchairs

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: persons which are in wheelchair since more than 6 months, no recent medical decompensation (<1 mois) Exclusion Criteria: recent medical decompensation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| WHOM scale (before consultation, after consultation) |  | 1 month |
104RA204 Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Participants

Study Overview
=================
Brief Summary
-----------------
To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.

Official Title
-----------------
Assessment of Safety and Efficacy of BG9924 in Subjects With RA Who Have Participated in Study 104RA202.

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Biological: Baminercept alfa (BG9924)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be a participant from Study 104RA202 (NCT 00664716) Stable dose of Methotrexate for the duration of the study Exclusion Criteria: Participants with a significant change in their medical history from their previous BG9924 study Any clinically significant infectious illness or serious local infection NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 2<br>Drug: BG9924 - dose administered as per Biogen-Idec protocol | Biological: Baminercept alfa (BG9924)<br>* dosage administered as per Biogen-Idec protocol<br>* Other names: LT beta;|
| Experimental: Group 1<br>Drug: BG9924 - dose administered as per Biogen-Idec protocol | Biological: Baminercept alfa (BG9924)<br>* dosage administered as per Biogen-Idec protocol<br>* Other names: LT beta;|
| Experimental: Group 3<br>Drug: BG9924 - dose administered as per Biogen-Idec protocol | Biological: Baminercept alfa (BG9924)<br>* dosage administered as per Biogen-Idec protocol<br>* Other names: LT beta;|
| Experimental: Group 4<br>Drug: BG9924 - dose administered as per Biogen-Idec protocol | Biological: Baminercept alfa (BG9924)<br>* dosage administered as per Biogen-Idec protocol<br>* Other names: LT beta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Observe The Long-Term treatment with BG9924 When Administered to Participants with RA who Previously Participated in a Biogen Idec Study |  | Duration of this study is 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Rheumatoid Arthritis, Baminercept alfa, Methotrexate, BG9924, Efficacy
Non Touch Technique for IUD Insertion

Study Overview
=================
Brief Summary
-----------------
The non touch technique is a modification of the traditional intrauterine device insertion technique. It abolishes the use of Allis and uterine sounding.

Official Title
-----------------
The Non Touch Technique for Intrauterine Device Insertion, a Single Blinded Randomized Control Trial

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Device: intrauterine device TCu 380A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females desiring contraception with the use of IUD Exclusion Criteria: Are pregnant or think they may be pregnant Septic pregnancy or abortion Have unexplained abnormal vaginal bleeding Have untreated cervical cancer Have malignant gestational trophoblastic disease Have uterine cancer Have uterine abnormalities Have or may have had a pelvic infection within the past three months Have or may have any sexually transmitted disease Have pelvic tuberculosis Are postpartum between 48 hours and 4 weeks Have benign gestational trophoblastic disease Have ovarian cancer Have AIDS (unless clinically well on anti-retroviral therapy)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non touch technique<br>the intrauterine device TCu 380A will be inserted in the conventional method as follows: First, insert the speculum and view the cervix. The position of the cervix will very often confirm if the uterus is anteverted or retroverted. Second, using the Allis forceps hold the back of a cotton-ball swab and dip it into a povidine-iodine disinfectant solution, or equivalent. Swab the cervix. Then cut the threads to the appropriate length and remove the speculum. This technique omits the sounding of the uterus which is considered a quintessential procedure before IUD insertion for which there is no one established piece of evidence.The IUD is checked afterwards by transvaginal ultrasound. | Device: intrauterine device TCu 380A<br> <br> * Other names: TCu 380A;|
| Experimental: Traditional IUD insertion<br>the intrauterine device TCu 380A will be inserted in the conventional method, and checked afterwards by transvaginal ultrasound. | Device: intrauterine device TCu 380A<br> <br> * Other names: TCu 380A;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of pain during IUD insertion | Pain will be assessed by the use of visual analog scale (VAS). | 5 months |
Lower Urinary Tract and Sexual Function in Women Following Surgery for Colorectal Disorders

Study Overview
=================
Brief Summary
-----------------
This is a prevalence study evaluating lower urinary tract, prolapse, bowel, and sexual symptoms in women with a colorectal disorder who are planning to undergo surgery. The purpose of this study is to identify the number of women who complain of lower urinary tract and bowel problems, including frequency, urgency, urinary incontinence, fecal incontinence, pain with intercourse, and other sexual problems prior to undergoing surgical management for a colorectal disorder.

Detailed Description
-----------------
Lower urinary tract symptoms, including urinary incontinence, voiding dysfunction, urgency, frequency, fecal incontinence, as well as sexual dysfunction, are directly affected by surgery for colorectal disorders. Increased risk of injury to the urinary tract is a recognized complication of pelvic surgery. These risks are related to the radical nature of pelvic surgery used to treat certain colorectal disorders, including colorectal malignancies and inflammatory bowel disease. Few studies have looked at the incidence of lower urinary tract symptoms and sexual dysfunction in patients with colorectal conditions before and after surgery. The primary goal of this study is to determine the prevalence of lower urinary tract symptoms in women undergoing surgery for colorectal ocnditions. We also want to describe the prevalence of these symptoms in different colorectal disorders, and how pelvic surgery impacts these symptoms.

Official Title
-----------------
Lower Urinary Tract and Sexual Function in Women Following Surgery for Colorectal Disorders

Conditions
-----------------
Lower Urinary Tract Symptoms, Colorectal Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects with a diagnosis of a colorectal disorder, including rectal prolapse, inflammatory bowel disease such as Crohn's disease, Ulcerative Colitis, and colorectal malignancies planning to undergo surgery Females have English as a primary language Exclusion Criteria: Subjects less than 18 years of age Subjects unable to give informed consent or complete the validated questionnaires

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lower urinary tract symptoms, Colorectal disorders, Urinary incontinence, Fecal incontinence, Voiding dysfunction, Urgency frequency, Sexual dysfunction, Colorectal malignancies, Inflammatory bowel disease
Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty: a Randomized Trial

Study Overview
=================
Brief Summary
-----------------
Numerous surgical techniques have been developped for the treatment of chondral and osteochondral defects of the knee. Among those techniques autologous chondrocyte transplantation (ACT) was promising but have potential drawbacks. A novel development by TBF is available. The aim of this randomized trial is to compared this new ACT technique to mosaicoplasty. Final outcomes were measured at 2 years using clinical evaluation scoring system (International Knee Documentation Committee), MRI and arthroscopy with biopsy. 64 patients are needed to detect a mean IKDC difference of at least 15 points with 90% power at a 5% alpha level. Twelve surgical centers in France are involved.

Official Title
-----------------
Phase 3 Study Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty

Conditions
-----------------
Knee Chondral or Osteochondral Defect

Intervention / Treatment
-----------------
* Procedure: Autologous chondrocytes transplantation
* Procedure: Mosaicoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: isolated femoral osteochondral lesion aged 18 to 50 grade 3 or 4 lesion (ICRS) sized 2,5 cm2 to 7,5 cm2. IKDC score below 55 Exclusion Criteria: pregnancy allergy arthrosis varus or valgus angle greater than 10° ACL laxity Severe chronic disease BMI > 30 Kg/m2 HIV, B or C Hepatitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Autologous chondrocytes transplantation | Procedure: Autologous chondrocytes transplantation<br>* Cartilage was harvested, then transferred for cell isolation and culture. Cells are suspended in agarose and transferred to cylindrical molds and surgically implanted 4 weeks later.<br>* Other names: Tissue Bank France;|
| Active Comparator: 2<br>Mosaicoplasty | Procedure: Mosaicoplasty<br>* Osteochondral patch are sampled and then implanted during the same surgical procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation scoring system |  | IKDC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI |  | at 2 years | 
| Arthroscopy with biopsy |  | at 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee, chondral defect, osteochondral defect
Non-interventional Study of Long-term Treatment of Psoriasis With Calcipotriol Plus Betamethasone in Gel Formulation

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to document the course of disease and relapse management during treatment with Daivobet® Gel under consideration of patient's individual application habits under daily use conditions.

Official Title
-----------------
Course of Psoriasis During Long Term Treatment With Calcipotriol Plus Betamethasone in Gel Formulation

Conditions
-----------------
Psoriasis Vulgaris, Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: Daivobet® Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with light to moderate psoriasis vulgaris of trunk and extremities and treatment with Daivobet® Gel was planned anyway. Minimum of 3 years diagnosed psoriasis vulgaris. Exclusion Criteria: Previous therapy with Daivobet® Gel Systemic therapy of psoriasis vulgaris Contraindications of Daivobet® Gel in the German package insert people that are incapable to give free consent

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| all eligible patients<br>Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance. | Drug: Daivobet® Gel<br>* Once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions. | Number of exacerbations and relapses during one year observation time | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | 6--point verbal rating scale | Baseline | 
| PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | Assessment on 6-step scale from no visible disease (O) to very severe disease (5) | 1 year | 
| Side Effects | Number of participants with serious and non-serious adverse drug reactions. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis, Psoriasis vulgaris, Plaque Psoriasis, Daivobet® Gel, Germany