linjc16/ctgov huggingface dataset:
VEST: The UK Vedolizumab Real Life Experience Study in Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
Vedolizumab has been approved for the treatment of both ulcerative colitis and Crohn's disease. The aim of this study is to capture the early real life UK experience of vedolizumab including the outcomes of treatment, describing the patient population treated, drug persistence, IBD control PROM, durable remission, tolerance and safety.

Official Title
-----------------
VEST: The UK Vedolizumab Real Life Experience Study in Inflammatory Bowel Disease

Conditions
-----------------
Ulcerative Colitis, Crohn's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants being given vedolizumab as part of routine care, and vedo naïve prior to study Age 18 or over Written informed consent obtained from patient for participation in the UK IBD Registry Exclusion Criteria: Patient unwilling to take part in the UK IBD Registry Unable to obtain written informed consent Patient is, in the opinion of the investigator, not suitable to participate in the study Patients with contraindications to the use of vedolizumab

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Steroid-free remission | Steroid-free remission at one year as defined by an HBI at week 56 of ≤4 or a UCDAI of ≤2 | Week 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission and response | Remission and response rates at week 6, 14, 30 and 54 | Multiple | 
| Durable remission | Durable remission / response i.e. at week 14, 30 and 54 | Multiple | 
| Effect of vedolizumab | Effect of vedolizumab on disease activity as measured by the PRO2, IBD Control PROM, Physician's Global Assessment and biomarkers of disease activity | TBC | 
| HES data | Healthcare usage at 1 year using HES data | 1 year | 
| Tolerance and safety | Tolerance and safety of vedolizumab at 1 year | 1 year | 
| Description of disease | Description of the demographics, disease phenotype, disease and treatment history and concomitant medication use of patients receiving vedolizumab | TBC | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Real world outcomes
Noncurative Endoscopic Resection of Colorectal Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Patients with noncurative resection after ESD for CRC were considered for additional surgical treatment. Then, they either underwent surgery with curative intent or did not, according to patients choice and surgeons indication / contraindication. We performed a retrospective revision of outcome data by clinical report review or phone calls.

Detailed Description
-----------------
Patients with noncurative resection after ESD for CRC were considered for additional surgical treatment. Then, they either underwent surgery with curative intent or did not, according to patients choice and surgeons indication / contraindication. We performed a retrospective revision of outcome data by clinical report review or phone calls.

Official Title
-----------------
Long-term Outcomes After Noncurative Endoscopic Resection of Colorectal Adenocarcinoma

Conditions
-----------------
Noncurative Resection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - undergoing non-curative colorectal endoscopic submucosal dissection (ESD). Exclusion Criteria: Histology other than cancer (adenocarcinoma). History of inflammatory bowel disease (IBD). Genetic conditions predisposing to CR. Lost to follow up or less than 6 months of follow up.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Survival | Overall survival cancer-specific survival and disease-free survival rate after noncurative ESD. | 6 Months |
CorMatrix ECM for Carotid Repair Following Endarterectomy Registry

Study Overview
=================
Brief Summary
-----------------
Assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair.

Detailed Description
-----------------
The objective of this registry is to capture and assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair per its FDA cleared Indications for Use. This registry provides an ongoing post-market surveillance mechanism to document clinical outcomes on the use of the CorMatrix ECM for Carotid Repair.

Official Title
-----------------
CorMatrix® ECM® for Carotid Repair Following Endarterectomy Registry

Conditions
-----------------
Carotid Stenosis

Intervention / Treatment
-----------------
* Device: CorMatrix ECM for Carotid Repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be undergoing carotid endarterectomy with patch angioplasty closure. Subject's operative surgeon intends to use CorMatrix ECM as the patch material for closure of the carotid artery per its FDA cleared Indications for Use. The subject must possess the ability to provide written Informed Consent. The subject must express an understanding and willingness to fulfill all of the expected requirements of this clinical protocol. Exclusion Criteria: Subjects with a known sensitivity to porcine material.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Carotid Endarterectomy Subjects<br>Subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair | Device: CorMatrix ECM for Carotid Repair<br>* Subjects must be undergoing carotid endarterectomy with patch angioplasty closure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid Procedure and Device Related Adverse Events to Determine Device Performance |  | 2 years |
Finasteride, Dutasteride and Insulin Action

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if an enzyme in the body (5-alpha reductase, 5αR) is important in controlling how the body handles sugar and fat. The investigators believe that 5αR is a crucial step in regulating these actions as well as controlling how insulin works in the body but regulating the amount of steroid hormones including cortisol and testosterone in the body. In previous clinical studies, the investigators have shown that the activity of 5αR increases as you gain weight and decreases with weight loss. In addition, work that the investigators have performed in the laboratory has shown that if you increase 5αR levels in liver cell grown in the laboratory, the amount of fat that they contain increases. The investigators would therefore like to demonstrate the effect of inhibition 5αR on the regulation of insulin, glucose and fat in the body.

Official Title
-----------------
An Open Label Study of 5α-reductase Inhibition on the Regulation of Insulin Action and Metabolic Phenotype in Healthy Volunteers.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Finasteride
* Drug: Dutasteride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male sex Age 18-65years BMI 20-35kg/m2 BMI >35kg/m2 Exclusion Criteria: Diabetes Mellitus Glucocorticoid use within the last 6 months Uncontrolled hypertension (BP>160/100mmHg) Drugs know to impact upon glucocorticoid metabolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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: Finasteride<br>Finasteride treatment 5mg for 3 weeks | Drug: Finasteride<br>* Finasteride 5mg once daily for 3 weeks<br>|
| Experimental: Dutasteride<br>Dutasteride treatment 0.5mg for 3 weeks | Drug: Dutasteride<br>* Dutasteride 0.5mg once daily for 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin sensitivity | stable isotope measurements of glucose production rate and glucose disposal | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adipose tissue insulin sensitivity | insulin mediated suppression of glycerol release into adipose tissue | 3 weeks |
Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population

Study Overview
=================
Brief Summary
-----------------
This study is a multi-center, randomized, triple-blind, placebo-controlled parallel-group trial, in which each participant is offered an N-of-1 trial. The purpose of this study is to assess the efficacy and safety of melatonin (3 mg or 6 mg) compared with placebo for initial insomnia in children with attention-deficit disorder.

Official Title
-----------------
Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population

Conditions
-----------------
Attention Deficit/Hyperactivity Disorder, Initial Insomnia

Intervention / Treatment
-----------------
* Dietary Supplement: Melatonin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: School-aged children and adolescents between the ages of 6 to 17 years Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Exclusion Criteria: Co-morbid psychiatric/neurological diagnoses that may affect sleep Co-morbid seizure disorder Co-morbid sleep disorder Concurrent use of immunosuppressive drugs, blood pressure drugs, selective serotonin re-uptake inhibitors or anticoagulant drugs; Pregnancy or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br>Dietary supplement: Melatonin 3 mg or 6 mg | Dietary Supplement: Melatonin<br>* Children <40 kg will take one tablet, melatonin 3 mg, oral, 30 - 60 minutes prior to bedtime. Children ≥40 kg will take two tablets, melatonin 3 mg, oral, 30-60 minutes prior to bedtime.<br>|
| Placebo Comparator: Placebo<br>Drug: Placebo | Drug: Placebo<br>* Placebo frequency and volume are identical to the experimental arm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in sleep onset latency (minutes) | The mean change in sleep onset latency will be measured using sleep diaries. | Daily, up to 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melatonin
Exploratory Study of Molecular Characterization in Patients With Metastatic Germ Cell Tumours Refractory/Resistant to Platinum Treatment

Study Overview
=================
Brief Summary
-----------------
To establish whether circulating tumour DNA is detectable in the plasma of patients with platinum refractory/resistant Germ Cell Tumours If ctDNA is detectable, perform exploratory analyses to: Describe the molecular aberrations in plasma from metastatic GCTs with platinum refractory/resistant disease Describe aberrations detected in sequential detected in sequential samples form the same individual patient and evaluate whether there are hyposthesis-generating changes that temporarily associate with clinical resistance.

Detailed Description
-----------------
This project will study the plasma of patients who have metastatic GCTs with platinum refractory/resistant disease in order to establish if ctDNA is detectable and then analyse the molecular aberrations. Archival diagnostic tissue will be recalled (this is the tissue used to make the initial diagnosis of testicular cancer). Excess tissue acquired from clinically mandated prospective biopsies will be stored and plasma which has been collected at a maximum of 15 time-points per year will be analysed. Clinical data will be accessed to make clinically meaningful associations with plasma and tissue molecular aberrations.

Official Title
-----------------
Exploratory Study of Molecular Characterization in Patients With Metastatic Germ Cell Tumours Refractory/Resistant to Platinum Treatment

Conditions
-----------------
Testicular Germ Cell Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed metastatic GCT refractory/resistant to platinum treatment Patients who have signed the 'Tissues for Research' consent form at the Royal Marsden Hospital and have blood samples stored in the RMH Biobank. Patients with no prior or current non-testicular invasive malignancy within the last 3 years, other than non-melanoma skin cancer or NCCN low risk prostate cancer (pT1 or pT2a Gleason ≤ 6, PSA ≤ 10 and ≤ 1cc total volume) Exclusion Criteria: n/a
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Circulating DNA in plasma is measurable | Measurement of plasma of patients with platinum refractory/resistant germ cell tumours | 1 year | 
| Exploratory analysis of circulating DNA | describe the molecular aberrations in plasma from metastatic germ cell tumours with platinum resistant/refractory disease Describe aberrations detected in sequential samples from the same indivivdual patient and evaluate whether there are hypothesis-generating changes that temporally associate with clinical resistance | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ctDNA
Confirmation of Ventilation and Intubation by Determination With Ultrasonography

Study Overview
=================
Brief Summary
-----------------
Chest radiography is the gold standard for confirming tracheal intubation. Bedside ultrasound can be a useful alternative. The investigators are conducting a multi-center, observational study from January 2019 to May 2020 (COVID-US Study) to determine the feasibility of tracheal and lung ultrasound in confirming endotracheal tube placement in the critically ill.

Detailed Description
-----------------
Endotracheal intubation is an important aspect of managing critically ill patients. Chest radiography remains the gold standard for confirming endotracheal tube positioning, however, ultrasonography can be a useful alternative. The objective of this study is to determine the feasibility of a combination of tracheal and thoracic ultrasonography to confirm adequate positioning of endotracheal tube placement in a cohort of critically ill participants including those with novel coronavirus-2019.

Official Title
-----------------
Confirmation of Ventilation and Intubation by Determination With Ultrasonography: A Multicenter Observational Study

Conditions
-----------------
Critical Illness, Mechanical Ventilation

Intervention / Treatment
-----------------
* Diagnostic Test: Point of care ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (> or equal to 18 years of age) requiring intubation and mechanical ventilation as a part of their routine care Exclusion Criteria: Recent neck or chest surgery Cervical spine immobilization Lack of availability of operators or equipment for performing the ultrasound protocol

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 |
| --- |
|Diagnostic Test: Point of care ultrasound|Tracheal and lung ultrasonography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance with next occurring chest radiograph | Adequate endotracheal tube position in agreement with chest radiograph | within 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal Intubation detection | Number of esophageal intubations detected during intubation attempt | within intubation attempt | 
| Right main or endobronchial intubation | Number of right main stem intubations detected with ultrasonography | within intubation attempt | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intubation, bedside ultrasound, point-of-care ultrasound
Supplementation of Critical Nutrients in a Plant-based Diet

Study Overview
=================
Brief Summary
-----------------
500 participants of the vegan/vegetarian congress VegMed are to be included, which should answer once (cross-sectional study) a medicine socio-behaviorist questionnaire on the topic supplementation of critical nutrients in a plant-based diet at the VegMed congress on 21/04/2018. The aim of the study is to understand how experts in this field behave and whether actions taken follow official recommendations.

Official Title
-----------------
Supplementation of Critical Nutrients in a Plant-based Diet as Assessed by Experts in Nutrition - a Cross-sectional Survey

Conditions
-----------------
Deficiency, Vitamin, Vegan's Anemia (Vitamin B12 Deficiency), Deficiencies Micronutrient

Intervention / Treatment
-----------------
* Other: Questionnaire on the topic Supplementation of critical nutrients in a plant-based diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants of the VegMed congress (Berlin, April 2018) Expertise of the respondent in the field of nutritional medicine Presence during the oral education to participate in the survey Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants of the VegMed congress (Berlin, April 2018)<br> | Other: Questionnaire on the topic Supplementation of critical nutrients in a plant-based diet<br>* No active intervention, only survey as mentioned above.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of critical nutrients in vegan diet | Cross-sectional survey | 21st April 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supplementation of critical nutrients in a vegan diet | Cross-sectional survey | 21st April 2018 | 
| Recommendations for patients by the experts | Cross-sectional survey | 21st April 2018 |
Schistosomiasis in Women of Reproductive Age in Burkina Faso: Implications for Control

Study Overview
=================
Brief Summary
-----------------
Cross-sectional study of prevalence and intensity of schistosome infection in pregnant women, follow-up into postpartum, and the association of schistosome infection with haemoglobin concentration, compared to a group of non-pregnant women.

Detailed Description
-----------------
The objective of this study is to investigate the epidemiology of schistosomiasis and anaemia among pregnant and non-pregnant women in Burkina Faso and explore the implications for the national schistosomiasis control programme and future studies. Specific objectives are: to determine the prevalence and intensity of schistosome infection in pregnant women attending for antenatal care and in non-pregnant women of reproductive age in an area which is hyperendemic for S.haematobium infection and in which there is little or no S.mansoni infection to determine the prevalence and intensity of schistosome infection in pregnant women attending for antenatal care and in non-pregnant women of reproductive age in an area in which S.mansoni infection is common to determine Haemoglobin concentration in pregnant women attending for antenatal care and in non-pregnant women of reproductive age in the regions described above to investigate the association between infection and haemoglobin concentration in pregnant and non-pregnant women to determine the prevalence of other parasitic infections in pregnant women and non-pregnant women including hookworms, ascaris, trichuris and malaria to demonstrate the research team's ability to follow-up pregnant women recruited at antenatal care clinics onto the postpartum period

Official Title
-----------------
Schistosomiasis in Women of Reproductive Age in Burkina Faso: Implications for Control

Conditions
-----------------
Schistosomiasis, Anaemia, Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women attending for ANC Non-pregnant women age 15-45 years accompanying relatives or children to the health centres or for immunization

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

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

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

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
-----------------
schistosomiasis, anaemia, pregnancy