linjc16/ctgov huggingface dataset:
Active Schools: Skelmersdale

Study Overview
=================
Brief Summary
-----------------
The aim of AS:Sk is to improve physical activity levels and health-related outcomes of children from the Skelmersdale area of West Lancashire through a school-based physical activity multi-component intervention.

Detailed Description
-----------------
The multi-component intervention is the third and final phase of the AS:Sk project. It will be implemented and evaluated in four of the seven participating schools. The remaining three schools will act as controls and will not implement any physical activity intervention during the period of the research project. Schools will be randomly assigned to either intervention or control conditions. The multi-component intervention will involve multiple areas of the schools' curricula, environments, or policies being targeted. Decisions regarding these intervention components will be influenced by what was deemed effective, and feasible within phase 2 of the project. Phase 2 included a four week trial of three different single component physical activity interventions across all participating schools. Phase 3 will be implemented for at least eight weeks and if successful, it would then be rolled out in the control schools at the end of the project. Participants from both intervention and control schools will take part in the measures for evaluation in this third and final phase of the project.

Official Title
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Active Schools: Skelmersdale

Conditions
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Physical Activity, Sedentary Lifestyle

Intervention / Treatment
-----------------
* Other: Multicomponent physical activity intervention


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Year 5 pupil attending participating schools Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Control vs Intervention clusters of schools
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multicomponent PA intervention<br>Intervention schools will adopt a multicomponent intervention by integrating physical activities into different parts of the school day | Other: Multicomponent physical activity intervention<br>* School-based multicomponent intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| School-day moderate-to-vigorous physical activity (MVPA) | Minutes of school-day MVPA accrued | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, Schools
Sexuality in Medically Assisted Procreation Pregnancies

Study Overview
=================
Brief Summary
-----------------
We wish to evaluate sexuality during pregnancy between spontaneous pregnancies and resulting from assisted procreation The literature is poor on thie subject

Official Title
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Evaluation of the Couple's Sexuality During a Pregnancy Resulting From Medically Assisted Procreation and Comparison With Sexuality During a Spontaneous Pregnancy

Conditions
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Pregnancy Related, Assisted Reproduction

Intervention / Treatment
-----------------
* Other: survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: physiological pregnancy pregnancy from assisted reproduction age over 18 to understand french patient's agreement Exclusion Criteria: pathological pregnancy

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Spontaneous pregnancy<br> | Other: survey<br>* survey on sexuality during pregnancy<br>|
| Assisted reproduction pregnancy<br> | Other: survey<br>* survey on sexuality during pregnancy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of sexual functioning with Female Sexual Function Index (FSFI) test |  | In the second trimester of the pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
assisted reproduction
Repeat Antenatal Corticosteroids

Study Overview
=================
Brief Summary
-----------------
This study will review records of women who broke their water early who received a repeat course of antenatal steroids.

Detailed Description
-----------------
Antenatal corticosteroids (ANCS) administered to a mother at risk of preterm delivery have been shown to decrease morbidity of prematurity if preterm birth occurs. Although early animal studies found that many repeated doses led to growth restriction a single repeat dose was found to benefit human neonates without a significant decrease in birth weight. Current guidelines recommend two doses of ANCS administered 24 hours apart as a single course. A repeat course of steroids is administered no less than 1-2 weeks after the first course if the mother remains at risk of preterm delivery. However, the main studies supporting the repeat course of ANCS excluded women with preterm premature rupture of membranes (PPROM). These authors designed exclusion criteria this way because of a theoretical increased risk of chorioamnionitis with administration of a glucocorticoid, which may have immunosuppressant effects. As a result, there is insufficient data to recommend a repeat dose of ANCS in women with PPROM. One study and its follow up publication did include women with PPROM. It did not find an increased incidence of chorioamnionitis between the treatment and the placebo groups, although women with PPROM were not analyzed separately. The combination of no increased incidence of chorioamnionitis but no clearly studied populations creates an opportunity for a randomized controlled trial of repeat doses of ANCS including only women with PPROM.

Official Title
-----------------
Retrospective Review of Repeat Antenatal Corticosteroids in Preterm Premature Rupture of Membranes

Conditions
-----------------
Antenatal Corticosteroids

Intervention / Treatment
-----------------
* Other: Antenatal corticosteroids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women with preterm premature rupture of membranes Exclusion Criteria: Women who did not have preterm premature rupture of membranes

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| antenatal corticosteroids<br>Women who received a rescue dose of steroids | Other: Antenatal corticosteroids<br>* Women and neonates with PPROM who received a repeat dose of antenatal corticosteroids, compared to women with PPROM who did not received a repeat course of antenatal corticosteriods<br>|
| No antenatal corticosteroids<br>Women who did not received a rescue dose of steroids | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant outcomes | infant birth weight | 1 year |
Prostate SABR With Intra-Prostatic SABR Boost

Study Overview
=================
Brief Summary
-----------------
Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 35 Gy in 5 fractions, once weekly to prostate with a simultaneous intra-prostatic boost to the MR detected nodule up to 50Gy. The pelvic lymph nodes and seminal vesicles will also receive 25 Gy in 5 weekly fractions.

Official Title
-----------------
Prostate SABR With Intra-Prostatic SABR Boost: A Phase II Study

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Radiation: Pelvic SABR with intra-prostatic SABR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed prostate adenocarcinoma High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA > 20 ng/mL Willing to give informed consent to participate in this clinical trial Exclusion Criteria: Prior pelvic radiotherapy Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease Contraindication to prostate MRI No evidence of castrate resistance (defined as PSA < 3 ng/ml while testosterone is < 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression. Definitive extrapelvic nodal or distant metastatic disease on staging investigations.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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: Experimental arm<br>SABR 35Gy/5 to prostate, up to 50Gy/5 to MR nodule, and 25Gy/5 to pelvic nodes and SVs | Radiation: Pelvic SABR with intra-prostatic SABR<br>* SABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Toxicity | To document the rate of acute urinary and bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) criteria | 3 month after accrual is completed |
Serum Metabolomics Study of Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
Polycystic ovary syndrome (PCOS) is a complex, heterogeneous disorder, which produces in 5-20% reproductive age women. In this study, a nontargeted metabolomics approach based on ultra high-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry will be used to investigate serum metabolic characteristics of PCOS. PCOS women and healthy control will be divided into two distinct groups based on multivariate statistical analysis. The findings of this study will offer a new insight to understand the pathogenesis mechanism, and the discriminating metabolites may provide a prospect for PCOS diagnosis.

Official Title
-----------------
Serum Metabolomics Study of Polycystic Ovary Syndrome Based on Liquid Chromatography-Mass Spectrometry

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCOS diagnostic criteria: According to the diagnostic criteria revised by the European Society of Human Reproduction and Embryology and the American Society for Reproductive Medicine at the Rotterdam in 2003,4 PCOS patients can be diagnosed if two of the three criteria are present after excluding congenial adrenal hyperplasia, Cushing's syndrome, androgen secreting tumors, or other related disorders. The three criteria are (1) oligo- and/or anovulation; (2) clinical and/or biochemical signs of hyperandrogenism (clinical manifestations of hyperandrogenism include presence of acne, hirsutism, and androgenic alopecia); (3) polycystic ovaries by ultrasound examination: presence of 12 or more follicles in each ovary measuring 2-9 mm on diameter and/or ovarian volume>10 ml. Age between 14 and 40 years 2 years after menarche Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCOS<br>PCOS women | |
| Healthy controls<br>Healthy control women | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The fatty acid amides (FAAs) metabolite changes | The metabolic changes between PCOS and healthy controls | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sulfated steroids metabolite changes | The metabolic changes between PCOS and healthy controls | one year | 
| The free fatty acid metabolite changes | The metabolic changes between PCOS and healthy controls | one year |
Outcome Of Treatment Of Prostate Cancer at Sohag University Hospital Between 2017 to 2021

Study Overview
=================
Brief Summary
-----------------
Worldwide, prostate cancer is the most commonly diagnosed male cancer and the fourth leading cause of cancer death in men. Risk stratification is according to cancer stage, Gleason score, and PSA level . Definitive treatment of localized disease ( low and favorable intermediate risk) includes watchful waiting , active surveillance , radiation therapy , radical prostatectomy and cryotherapy .Primary treatment of unfavorable intermediate risk , high risk localized disease and locally advanced prostate cancer , includes both radical prostatectomy (RP) and EBRT + long-term androgen deprivation therapy (ADT) .Treatment options of metastatic prostate cancer include pain medications, bisphosphonates, hormonal treatment, chemotherapy, radiotherapy, immunotherapy, focused radiation, and other targeted therapies .

Official Title
-----------------
Outcome Of Treatment Of Prostate Cancer at Sohag University Hospital Between 2017 to 2021

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: androgen deprivation therapy
* Radiation: external beam radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at age of 18 years old and above. All stages and grades of prostate cancer. Epithelial types of prostate cancer. Exclusion Criteria: Age below 18 years old. Presence of other malignancies.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: androgen deprivation therapy|outcome of hormonal treatment as androgen deprivation therapy on prostate cancer patient on survival and relapse|
|Radiation: external beam radiotherapy|outcome of radiotherapy as external beam radiotherapy on prostate cancer patient on survival and relapse|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | Overall survival defined as the time from the date of diagnosis to the last date seen . | 6 months | 
| progression free survival | Progression-free survival defined as the length of time during and after the treatment of cancer that a patient lives with the disease but it does not get worse. | 6 months | 
| disease free survival | Disease free survival defined as the time from the end of treatment to the date of first relapse . | 6 months |
Swiss Atrial Fibrillation Cohort Study

Study Overview
=================
Brief Summary
-----------------
Swiss-AF is a prospective observational, multicentric cohort study in Switzerland. Overall, 2600 patients with documented atrial fibrillation aged >65 years will be included and followed on a yearly basis. Yearly clinical examinations include a detailed questionnaire on personal characteristics, a resting electrocardiogram, neurocognitive function tests and questionnaires on disability and quality of life. Blood sampling and brain magnetic resonance imaging are scheduled at baseline and after 2 years of follow-up. The main study aims of this long term prospective study are to increase our knowledge on structural brain damage and its changes over time in patients with atrial fibrillation, to gain additional insights on the incidence and underlying mechanisms of cognitive decline in patients with atrial fibrillation and to evaluate the interrelationships of structural and functional brain damage in this population.

Official Title
-----------------
Swiss Atrial Fibrillation Cohort Study - SWISS AF

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: atrial fibrillation documented within the last 24 months age >=45 years Exclusion Criteria: acute illness inability to provide informed consent Only short episodes of reversible forms of atrial fibrillation

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| Atrial Fibrillation<br>Cohort Study on patients with atrial fibrillation in Switzerland | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke or systemic embolism |  | 2018 (after an average of 2.5 years of follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization for heart failure |  | 2018 (after an average of 2.5 years of follow-up) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, dementia, cognitive dysfunction, stroke, Magnetic resonance imaging
An Observational Study on Long-Term Effectiveness and Safety of RoActemra/Actemra (Tocilizumab) in Daily Practice in Patients With Rheumatoid Arthritis (ICHIBAN)

Study Overview
=================
Brief Summary
-----------------
This prospective, multi-center observational study will assess the long-term efficacy and safety of RoActemra/Actemra in daily practice in patients with active moderate to severe rheumatoid arthritis who have an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. Data will be collected from patients initiated on RoActemra/Actemra treatment according to label by decision of the treating physician. Anticipated time for data collection from each patient will be 2 years.

Official Title
-----------------
A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Long-term Effectiveness and Safety of Tocilizumab in Patients With Active Rheumatoid Arthritis in Daily Practice

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Active moderate to severe rheumatoid arthritis Inadequate response or intolerant to previous therapy with one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists Prescription of RoActemra/Actemra according to label Exclusion Criteria: N/A

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with clinical remission defined as disease activity score DAS28 < 2.6 |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to DAS28 remission |  | 5 years | 
| Proportion of patients with good or moderate response according to EULAR criteria |  | 5 years | 
| Time to good or moderate response according to EULAR criteria |  | 5 years | 
| Factors related to response (C-reactive protein, rheumatoid factor, inadequate response to DMARDs or anti-TNF, duration of illness) |  | 5 years | 
| Dose-modifications and discontinuations of RoActemra/Actemra |  | 5 years | 
| Safety: Incidence of adverse events |  | 5 years | 
| Efficacy of other possible RA therapies in case of inadequate response to RoActemra/Actemra (DAS28, EULAR criteria) |  | 5 years | 
| Safety of other possible RA therapies in case of inadequate response to RoActemra/Actemra (adverse events) |  | 5 years |