linjc16/ctgov huggingface dataset:
The Effect of Blood Transfusion on Endothelial Function

Study Overview
=================
Brief Summary
-----------------
Blood transfusion is often used to treat patients with Anemia. The period of storage of blood products prior to use for transfusion may vary. Prolonged storage of blood products may result in changing their biochemistry. This study aims to look into whether the transfusion of old blood, which is stored for more than 7 days, as compared to the transfusion of Fresh blood, which is stored for less than 7 days, will affect endothelial function.

Detailed Description
-----------------
Endothelial function assessed pre and post transfusion. The EndoPAT uses a unique bio-sensors that are placed on the fingertips to measure pressure. The test takes about 20-25 minutes. During the procedure the participant will have biosensors placed on the index finger of each hand. The nondominant arm will have a blood pressure cuff applied with sufficient pressure for five minutes. At the end of the test the device will provide a reading that assesses the level of endothelial function/dysfunction.

Official Title
-----------------
The Effect of Blood Transfusion on Endothelial Function

Conditions
-----------------
MDS, Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age is > 18 years Need recurrent blood transfusion Exclusion Criteria: Latex Allergy Life expectancy is less than 6 months History or evidence of drug or alcohol abuse in the last 12 months Any medical condition that will place the participant at a higher risk if they participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| fresh blood Transfusion<br> | |
| Old blood transfusion<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | The function of the blood vessels will be assessed with the EndoPAT device. This test is done 15 minutes prior to the transfusion and again 30 minutes post the transfusion. Patients that will receive both fresh and old blood will be included. | Change in endothelial function compared to baseline. Test is done 15 minutes prior to transfusion and 30 minutes post blood transfusion. The test is repeated when patient received another blood transfusion. The results of the change are compared. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood transfusion, Storage Lesion, Endothelial dysfunction, Nitric Oxide
Racing and Crowded Thoughts in Mood Disorders

Study Overview
=================
Brief Summary
-----------------
Racing thoughts relate to subjective acceleration of thinking which has been essentially associated with manic episodes in bipolar disorder. Qualitatively, the phenomenology of racing thoughts in major depression seems to differ from rumination and pure manic racing thoughts: thoughts of all kinds accumulate in the patient's head. Recent qualitative evidence is consistent with the existence of these two kinds of thought overactivity related to mood disorders. In order to evaluate this and better understand the psychopathological and cognitive mechanisms that underlie thought overactivity in mood disorders, we have created a 34-item self-questionnaire - the Racing and Crowded Thoughts Questionnaire (RCTQ) and a number of neuropsychological tasks (time perception, cognitive flexibility). Also, given the relationship between mood disorders and creativity, it is likely that thought overactivity is related to increased creativity. We aim at evaluating this relationship through the French version of the Cognitive Processes Associated with Creativity scale (CPAC).

Official Title
-----------------
Psychopathological and Cognitive Mechanisms of Racing and Crowded Thoughts in Mood Disorders

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Behavioral: questionary


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bipolar disorder or depressive disorder 18 -65 years old Exclusion Criteria: neurological conditions or sequelae substance abuse in the last 10 months schizophrenia ADHD Borderline personality disorder Pregnant women- Subjects under legal supervision

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

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 |
| --- | --- |
| mood disorders<br>Questionary and neuropsychological tasks will be administered | Behavioral: questionary<br> <br> |
| control<br>Questionary and neuropsychological tasks will be administered | Behavioral: questionary<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of the scale of Crowded Racing Thoughts Questionary = (RCTQ scale that assesses the two forms of racing thoughts) | Demonstrated a two-factor structure (crowded and racing) assessment concurrent and discriminant validity. | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of executive and temporal mechanisms involved in racing thoughts |  | one week |
Follow Up of High Risk Hodgkin Lymphoma in First Complete Remission

Study Overview
=================
Brief Summary
-----------------
Cohort study enrolled high-risk Hodgkin Lymphoma patients in first relapse after induction therapy followed after remission either with a systemic imaging-based surveillance (Imaging cohort) or with standard clinical-based surveillance (standard cohort).

Official Title
-----------------
Impact on Survival of Early Detection of Recurrence in the Follow Up of High Risk Hodgkin Lymphoma in First Complete Remission

Conditions
-----------------
Hodgkin Lymphoma, High Risk, Relapse

Intervention / Treatment
-----------------
* Diagnostic Test: Standard cohort: Clinical lab follow-up
* Diagnostic Test: Imaging cohort: integrated imaging follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High risk Hodgkin Lymphoma achievement of complete response to first line therapy Exclusion Criteria: comorbidities that could impair participation in follow-up procedures

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 |
| --- | --- |
| Standard cohort<br>Clinical-based surveillance after first complete remission in High risk Hodgkin Lymphoma patients: symptom assessment blood tests physical examination | Diagnostic Test: Standard cohort: Clinical lab follow-up<br> <br> |
| Imaging cohort<br>Clinical-based surveillance after first complete remission in High risk Hodgkin Lymphoma patients: symptom assessment blood tests physical examination Positron Emission Tomography (PET)/Computed Tomography (CT) or Chest X-Ray ultrasonography scan of superficial, mediastinal, abdominal and pelvic lymph nodes | Diagnostic Test: Standard cohort: Clinical lab follow-up<br> <br> Diagnostic Test: Imaging cohort: integrated imaging follow-up<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event Free Survival (EFS) | Events: refractoriness relapse death | Time period from the first relapse after induction therapy to the date of an event (refractoriness, relapse, or death) or the last follow-up visit after autologous stem cell transplantation (ASCT), up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EFS for clinically silent relapses | Events: refractoriness relapse death | Time period from the first relapse after induction therapy to the date of an event (refractoriness, relapse, or death) or the last follow-up visit after autologous stem cell transplantation (ASCT), up to 2 years | 
| Response rate | Rate of response | After salvage therapy and autologous stem cell transplantation (ASCT), up to 2 years |
Lung Ultrasound in Diagnosis and Management of Bronchiolitis Bronchiolitis

Study Overview
=================
Brief Summary
-----------------
To evaluate the correlation between clinical and ultrasound findings in children presented with signs suggestive of bronchiolitis and to validate an ultrasound score for bronchiolitis that will correlate with specific clinical outcomes.

Official Title
-----------------
Lung Ultrasound: a Useful Tool in Diagnosis and Management of Bronchiolitis?

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Other: Lung US


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children presented with signs suggestive of bronchiolitis Exclusion Criteria: other major pathology

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bronchiolitis<br>children presented with signs suggestive of bronchiolitis | Other: Lung US<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical and ultrasound findings | To evaluate the correlation between clinical and ultrasound findings in children presented with signs suggestive of bronchiolitis | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ultrasound score for bronchiolitis and clinical outcome | to validate an ultrasound score for bronchiolitis that will correlate with specific clinical outcomes | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchiolitis
Gemcitabine, Oxaliplatin and Radiotherapy in Treating Patients With Completely Resected Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
A non-randomized phase II study to determine the efficacy and safety of the combination of Gemcitabine and Oxaliplatin followed by Gemcitabine and radiotherapy in patients with surgically resected pancreatic cancer.

Official Title
-----------------
A Phase II Trial of Adjuvant Treatment With Gemcitabine and Oxaliplatin Followed by Concomitant Gemcitabine and Radiation Therapy in Patients With Resected Pancreatic Adenocarcinoma

Conditions
-----------------
Pancreatic Neoplasms

Intervention / Treatment
-----------------
* Drug: Gemcitabine
* Drug: Oxaliplatin
* Procedure: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed adenocarcinoma of the pancreas Patient have undergone a potentially curative resection No previous irradiation to the planned field Negative pregnancy test for child bearing women Exclusion Criteria: Non-adenocarcinoma pancreatic cancer Treatment with any drug within the last 30 days that has not received regulatory approval. Serious systemic disorder Metastatic disease Pregnancy, breast feeding

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine|nan|
|Drug: Oxaliplatin|nan|
|Procedure: Radiotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate recurrence free one year survival, time to disease progression and local recurrence rate, analyzed at the end of the study |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess overall survival at the end of the 24 months follow up period;To assess acute and late toxicity (every month for the first 3 months and then every three months for 24 months after treatment discontinuation) |  |  |
ODM-207 in Patients With Advance Solid Tumours

Study Overview
=================
Brief Summary
-----------------
This is a first-in-man study to assess the safety and tolerability and to characterise the pharmacokinetics of ODM-207.

Official Title
-----------------
Safety and Pharmacokinetics of ODM-207 in Patients With Selected Advanced Solid Tumours: an Open-label, Non-randomised, Uncontrolled, Multicentre, First-in-human Study With Cohort Expansion

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: ODM-207


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically or cytologically confirmed locally advanced or metastatic cancer for which no effective standard therapy exists or are refractory or resistant to conventional therapy Life expectancy >12 weeks Patient may have either measurable or non-measurable disease, but must have disease that can be evaluated for improvement of progression ECOG performance status of 0 to 1 Exclusion Criteria: History of bleeding disorder or significant bleeding episode within 6 months prior to study treatment Subjects receiving anticoagulants or medications that durably inhibit platelet function (7-day wash-out prior to study treatment) History of or current leptomeningeal or brain metastasis or spinal cord compression.

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ODM-207<br>Escalating doses of ODM-207 | Drug: ODM-207<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose | Highest dose level at which <33% of patients in a cohort experience Dose Limiting Toxicity (DLT) | 28 days |
Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain on-eye clinical performance data to evaluate the stability of axis orientation of DDT2 toric contact lenses in the intended population.

Detailed Description
-----------------
This is a single-visit, non-dispense study where subjects will be exposed to the test lenses for approximately 1 hour.

Official Title
-----------------
Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens

Conditions
-----------------
Astigmatism

Intervention / Treatment
-----------------
* Device: verofilcon A toric contact lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to understand and sign an informed consent form; Successful wear of spherical or toric soft contact lenses in both eyes, as specified in the protocol; Willing to NOT use rewetting/lubricating drops at any time during the study; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Any eye condition that would contraindicate contact lens wear, as determined by the Investigator; History of eye surgery within the previous 12 months, as specified in the protocol; Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear; Other protocol-specified exclusion criteria may apply.

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DDT2 Toric<br>Verofilcon A toric contact lenses worn in both eyes | Device: verofilcon A toric contact lenses<br>* Daily disposable toric soft contact lenses<br>* Other names: DDT2 Toric;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of lenses with axis orientation within ±30° from the intended axis, 10 minutes after lens insertion | Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis. | Day 1, 10 minutes after lens insertion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Silicone hydrogel contact lens, Axis orientation, Astigmatism, Toric contact lens, Daily disposable
FODMAPs and Refractory GERD

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the effects of a low Fermentescible Oligosaccharides Disaccharides Monosaccharides and Polyols (FODMAP) diet in patients with documented refractory GERD on proton pump inhibitor (PPI) therapy.

Detailed Description
-----------------
Colonic fermentation has been shown to influence oeso-gastric motility : increased gastric relaxation, increased rate of lower esophageal sphincter relaxation. Experimental increased colonic fermentation (FOS in diet) increase the occurrence of reflux events in patients with GERD. The aim of this study is to compare the low-FODMAP diet and classical GERD dietary recommendations (avoid fatty meals, head of bed elevation etc..) in patients with refractory GERD symptoms.

Official Title
-----------------
Randomized Controlled Study of Low-FODMAP Diet in Patients With GERD Refractory to Protons Pump Inhibitors

Conditions
-----------------
Gastro-esophageal Reflux Disease (GERD)

Intervention / Treatment
-----------------
* Dietary Supplement: Low-FODMAP diet
* Dietary Supplement: GERD diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Affiliation to French Social Security Informed written consent RDQ score > 3 Abnormal pH-impedance monitoring on PPI twice daily (since 3 months) according to normal values published by Zerbib et al (CGH 2013) Exclusion Criteria: Pregnancy or breast feeding Women of childbearing potential without an effective method of contraception Person under guardianship History of thoracic of abdominal surgery (excepted appendectomy and cholecystectomy)

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-FODMAP diet<br>FOS in diet | Dietary Supplement: Low-FODMAP diet<br> <br> |
| Active Comparator: Classical GERD diet<br>avoid fatty meals, head of bed elevation... | Dietary Supplement: GERD diet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with clinical remission as defined by a RDQ score ≤ 3 |  | at Week 4 of diet | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between-group comparison of efficacy | This measure is a composite with : Reflux Disease Questionnaire (RDQ) scores Francis Irritable Bowel Syndrome (IBS) score Quality of life (GIQLI) score and reflux parameter on pH-impedance monitoring | at Week 4 of diet | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FODMAP, Diet, pH-impedance monitoring
The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant

Study Overview
=================
Brief Summary
-----------------
This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of isotretinoin on the etonogestrel (ENG) contraceptive implant.

Detailed Description
-----------------
The Investigators will enroll only women with an etonogestrel contraceptive implant in place who are initiating isotretinoin therapy through their dermatologist. The Investigators will monitor the subjects serum etonogestrel concentration during isotretinoin therapy but no medications will be provided through this study. No medical devices will be inserted as part of this study either.

Official Title
-----------------
The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a secondary form of non-hormonal contraception or abstain during isotretinoin therapy and four weeks afterwards Have at least two negative pregnancy tests at least 19 days apart prior to initiating isotretinoin therapy Have normal baseline laboratory evaluation including liver function tests, basic metabolic panel, and complete blood count Willing to abstain from taking any Vitamin A supplement during the study period Have a Body Mass Index (BMI) >= 18.5 Exclusion Criteria: Currently breastfeeding Known contraindications to isotretinoin Currently taking any known cytochrome P-450 3A4 enzyme inducers or inhibitors

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Serum Etonogestrel (ENG) Level | ENG levels will be measured prior to initiation of isotretinoin therapy. | Baseline (enrollment) | 
| Serum Etonogestrel (ENG) Level | ENG levels will be measured 4 weeks after of initiation of isotretinoin therapy. | 4 weeks | 
| Serum Etonogestrel (ENG) Level | ENG levels will be measured 9 weeks after of initiation of isotretinoin therapy. | 9 weeks |