linjc16/ctgov huggingface dataset:
Folate and Protection Against Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
This is a randomised double-blind placebo-controlled trial to see whether giving a low dose of the vitamins folic acid and riboflavin is beneficial to women who have very low grade abnormalities of the cervical cells.

Detailed Description
-----------------
The overall aim of the study is to evaluate interactions between intakes of folic acid and riboflavin with a common polymorphism relevant to folate metabolism, in determining the risk of cervical cancer in women who carry high risk human papillomavirus. We will test the following hypotheses: Supplements of riboflavin and folic acid will increase the rate of regression of low grade cervical intra epithelial neoplasia (CIN1). Effects of supplemental folic acid and riboflavin on CIN1 regression are modulated by a common polymorphism in the MTHFRC677T gene. We will recruit women with biopsy-proven CIN1 and carrying high risk HPV infection, and randomise to a 12month intervention of 1.2mg folic acid and 5mg riboflavin or placebo. The primary outcome will be regression of biopsy-proven CIN1, and secondary outcomes will include measures of DNA stability.

Official Title
-----------------
A Randomised Placebo-Controlled Trial to Evaluate Interactions Between Riboflavin and Folate Intake and Genotype in Reducing Risk of Cervical Cancer

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Drug: Folic acid with riboflavin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy-diagnosed CIN1 infection with oncogenic HPV Exclusion Criteria: Any other stage of cervical abnormality pregnant or planning a pregnancy diabetic taking B vitamin supplements taking anti-epileptic treatment taking methotrexate bleeding after intercourse abnormal GI function infection with chlamydia, HIV or other agent

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Folic acid with riboflavin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of regression of CIN1 to normal over a 12 month intervention |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA strand breakage, in cervical cells |  |  | 
| DNA hypomethylation, in cervical cells |  |  | 
| Cervical cell folic acid |  |  | 
| HPV persistence over 12 months of intervention |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Randomised placebo controlled intervention trial, Folic acid, Riboflavin, cervical cancer
Is There a Comorbidity Between Migraine and Allergic Rhinitis?

Study Overview
=================
Brief Summary
-----------------
The researchers investigated the relationship between migraine and allergy. For this purpose, the researchers designed a controlled study to evaluate nasal symptoms and signs; and to perform Specific Immunoglobulin E (IgE) measurements in migraine patients and healthy subjects. According to these results the prevalence of allergic rhinitis in migraine group was planned to be compared to that of the healthy controls, statistically.

Conditions
-----------------
Migraine, Allergic Rhinitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with migraine Exclusion Criteria: other neurologic disorders that may contribute to headaches, such as stroke, cerebral palsy, trigeminal neuralgia, and seizure disorder also acute and chronic sinusitis.
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 |
| --- | --- |
| Migraine group<br>Patients diagnosed with migraine | |
| Healthy group<br>Healthy subjects with no migraine as control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific Immunoglobulin E (IgE) | Blood samples were taken from study and control group for the determination of Specific IgE panel against six different allergens: (1) fungi, (2) grass pollens, (3) tree pollens, (4) wild herbs, (5) mite 1, (6) mite 2. For all of specific IgE panels, <0,7 RU/ml was negative; and >0,7 RU/ml was Positive. | 1 day | 
| Nasal Symptom Scores | Symptoms were assessed with a questionnaire for the presence and severity of allergic rhinitis (AR) symptoms on a scale of 0-3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). Symptoms of AR (Nasal discharge, nasal congestion, itching and sneezing) were graded between 0-3. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine, allergic rhinitis, Specific Immunoglobulin E (IgE), nasal symptoms, signs of allergy.
Sopran - Omeprazole Treatment Versus Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study gastritis, GI symptoms during long term omeprazole treatment

Official Title
-----------------
Omeprazole Versus Anti-reflux Surgery in the Long-term Management of Peptic Esophagitis - a 10 Year Follow up Study of Patients Previously Studied for 5 Years - A Nordic Multicentre Study

Conditions
-----------------
GERD

Intervention / Treatment
-----------------
* Drug: Omeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous inclusion into Astra study I-635 and willing to continue for another 10 years, Exclusion Criteria: Pregnancy or lactation; Woman planning pregnancy within 5 years; Suspected or confirmed malignancy; Documented eradication of Helicobacter pylori.

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: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the safety of omeprazole during long term treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the long term control of reflux symptoms, healing of esophagitis and persistence of post fundoplication symptoms during long term treatment of omeprazole |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Maintenance of healed erosive esophagitis
MONO: Symbicort® Single Inhaler Therapy and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the efficacy of a flexible dose of Symbicort (budesonide/formoterol) with conventional stepwise best standard treatment in patients with persistent asthma.

Official Title
-----------------
A Comparison of the Efficacy of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5 mg 1 Inhalation b.i.d. Plus As-needed) and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults. A Randomized, Open, Parallel-group, Multicentre 26-weeks Study

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Budesonide/Formoterol Turbuhaler
* Drug: Conventional Best Asthma Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of asthma >= 3 months Prescribed daily use of glucocorticosteroids for at least 3 months prior to Visit 1 Exclusion Criteria: Smoking history > 10 pack-years Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion Any significant disease or disorder that may jeopardize the safety of the patient. Additional inclusion and exclusion criteria will be evaluated by the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 12 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

| Intervention/Treatment |
| --- |
|Drug: Budesonide/Formoterol Turbuhaler|nan|
|Drug: Conventional Best Asthma Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first severe asthma exacerbation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of asthma exacerbations |  |  | 
| Mean use of as-needed medication |  |  | 
| Prescribed asthma medication |  |  | 
| Asthma Control Questionnaire |  |  | 
| Safety: serious adverse events and discontinuations due to adverse events |  |  | 
| All variables assessed over the 6 month treatment period |  |  |
Satisfaction With Pediatric Intravenous Catheter Placement in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the satisfaction among parents and nurses of pediatric patients with IV catheter placement in the Emergency Department.

Detailed Description
-----------------
The objectives of this study are to evaluate whether the proportion of parents satisfied with their child's IV placement procedure is higher after the introduction of Zingo compared to standard of care and to evaluate changes in nursing staff satisfaction with performing IV placement procedures after using Zingo prior to IV placement compared to standard of care.

Official Title
-----------------
An Evaluation of Parent and Nurse Satisfaction Associated With Pediatric Peripheral Intravenous Catheter Placement Using Standard of Care vs. ZingoTM in the Emergency Department

Conditions
-----------------
Intravenous Placement Procedure

Intervention / Treatment
-----------------
* Behavioral: Zingo TM (lidocaine hydrochloride monohydrate) powder intradermal injection system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PHASE A: Parent of a pediatric patient from the age of 3 to 18 years of age who requires a peripheral IV placement in the Emergency Department Parent must be able to read and understand English and provide written informed consent Parent must be present during the IV placement PHASE B: Parent did not participate in Phase A Nurse has completed Zingo TM in-service training prior to participation Zingo is used prior to performing the IV placement procedure Exclusion Criteria: - Parent of patient with a serious unstable medical or psychological condition that would compromise participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Lifestyle<br>Observatonal | |
| 2: Lifestyle<br>Observational | Behavioral: Zingo TM (lidocaine hydrochloride monohydrate) powder intradermal injection system<br>* 0.5 mg lidocaine hydrochloride<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent's satisfaction with IV placement procedure |  | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nurse'e satisfaction with performing IV placement |  | 18 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IV placement; Parent satisfaction level
Effects of Legume Intake on Cardiovascular Risk Factors Among Adults at Risk for Diabetes

Study Overview
=================
Brief Summary
-----------------
This randomized cross-over study was designed to investigate the effects of legume enriched diet consumption on cardiovascular risk factors among first degree relatives of diabetic patients.

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: nutritional intervention
* Other: life style modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects aged more than 30 years no history of chronic diseases no use of blood glucose lowering drugs be wiling to participate to study Exclusion Criteria: do not follow study protocol incidence of chronic diseases during the study to start use of blood glucose lowering drugs or to change dose and type of current medications

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: legume enriched diet<br>legume consumption, 4 servings per week, for 6 weeks | Other: nutritional intervention<br> <br> |
| Active Comparator: healthy dietary recommendations<br>no nutritional intervention | Other: life style modification<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose (mg/dl) | amounts of FBG | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C (%) | amounts of HbA1C | 14 weeks | 
| Total cholesterol (mg/dl) | amounts of TC | 14 weeks | 
| Low Density Lipoprotein (mg/dl) | amounts of LDL | 14 weeks | 
| High Density Lipoprotein (mg/dl) | amounts of HDL | 14 weeks | 
| Triglyceride (mg/dl) | amounts of TG | 14 weeks |
Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600)

Study Overview
=================
Brief Summary
-----------------
Patients with malignant melanoma who had undergone surgery will receive adjuvant treatment with high-dose Intron A for one year. The objective of this study is to maximize treatment compliance by proactive management of side effects in a day-to-day healthcare setting.

Official Title
-----------------
Guidelines to the Intron A® Health Management Program II: A Nursing Support Program for Patients With High-Risk Melanoma Receiving High Dose Intron A Therapy

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Biological: Intron A (interferon alfa-2b; SCH 30500)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Age > 18 years Confirmed melanoma Patient has been prescribed Intron A therapy for High-Risk Stage II & III Melanoma Intron A therapy started within 70 days of surgery (additional 15 days may be granted by the sponsor upon written approval) Proper contraception in both male and female subjects and the female partner(s) of male study subjects Exclusion Criteria: Metastatic disease at the time of diagnosis Other malignancies History of non compliance to other therapies Pregnancy or breast feeding Previous Intron A therapy

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 |
| --- | --- |
| Intron A<br>Patients with malignant melanoma who are free of disease post-surgery but at high risk for systemic recurrence. | Biological: Intron A (interferon alfa-2b; SCH 30500)<br>* The recommended regimen includes an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 million international units per square meter (MIU/m^2). The induction treatment should be followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy should be administered for a total of one year unless the disease progresses or the treatment has lead to recurrent unmanageable serious adverse effects.<br>* Other names: SCH 30500;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Completed Treatment | Treatment completion was defined as those who completed both the induction and maintenance phases. | Up to 1 year |
Association Between Dermatoporosis and Fractural Risk

Study Overview
=================
Brief Summary
-----------------
There is a need for new tools to identify patients who may have osteoporosis before a fracture occurs.

Official Title
-----------------
Association Between Dermatoporosis and Fractural Risk

Conditions
-----------------
Dermatoporosis

Intervention / Treatment
-----------------
* Diagnostic Test: Dual X-ray absorptiometry (DMO) densitometry.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged between 40 and 90 years old who has to undergo a bone densitometry (BMD) examination by dual X-ray absorptiometry Affiliate or beneficiary of a Social Security scheme Express consent to participate in the study. Exclusion Criteria: Patient benefiting from a legal protection measure Pregnant or nursing woman.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Dual X-ray absorptiometry (DMO) densitometry.|Simple clinical examination with forearm inspection and palpation; Radiological examination of BMD; Calculation of the FRAX® score; Fact sheet on patients with dermatoporosis, proposal of a topical treatment (cosmetic cream) and completion of the questionnaire specific to dermatoporosis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare fracture risk between patients with dermatoporosis and those without dermatoporosis | The fracture risk will be calculated using the FRAX score. The presence of dermatoporosis will be assessed by a simple clinical examination of the forearms and defined by the presence of three clinical signs: cutaneous atrophy, Bateman purpura and presence of pseudo-stellar scars. | BASELINE |
Outcome of Very Old Patients Admitted for Elective Major Surgery, the Effect of Frailty

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the effect of frailty in patients ≥ 80 years admitted for elective major abdominal surgery.

Detailed Description
-----------------
Patients ≥ 80 years admitted for elective major abdominal surgery will be asked to participate in this study where frailty will be scored using the Clinical Frailty Scale and by measuring hand-grip-strength. Primary outcome is mortality at 30 days, 90 days and 1 year.

Official Title
-----------------
Outcome of Very Old Patients Admitted for Elective Major Surgery, the Effect of Frailty

Conditions
-----------------
Frail Elderly Syndrome, Surgery--Complications

Intervention / Treatment
-----------------
* Other: Scoring of frailty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 80 years or above elective abdominal surgery informed consent Exclusion Criteria: age less than 80 years emergency surgery palliative surgery ( e.g performing entero-enteroanastomosis to relieve obstruction)

Ages Eligible for Study
-----------------
Minimum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Frail, non-frail<br>Frail Group: Those individuals identified as frail by low hand-grip-strength and/or the Clinical Frailty Scale. Non-frail Group: Those individuals identified as not frail by hand-grip-strength and/or the Clinical Frailty Scale. | Other: Scoring of frailty<br>* Patients will be scored by the Clinical frailty Scale Patients' hand-grip-strength will be measured by a dynamometer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to death | Time until subject dies or up to one year after surgery | Up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Complications as graded by the Clavien-Dindo system and defined by the EPCO-definitions. | Up to 90 days after surgery | 
| Discharge to institution | Discharge to nursing home | Up to 90 days after surgery | 
| Worsening functional status | Increased need of assistance in performing ADL. | 1 year postoperatively. | 
| Mortality at 30 days | Death within 30 days after surgery | 30 days after surgery | 
| Mortality at 90 days | Death within 90 days after surgery | 90 days after surgery |