linjc16/ctgov huggingface dataset:
Daily Monitoring of Respiratory Symptoms and Spirometry During ETI Treatment in Persons With Cystic Fibrosis.

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to provide optimal monitoring and support when initiating ETI treatment in eligible persons with cystic fibrosis (aged 12 y +) and to document on a daily basis, from 72 hours before the start of treatment and then for 14 days i) i) FEV1 changes (home spirometry), ii) ii) respiratory symptoms changes, iii) any possible side effects. Through a dedicated electronic platform, these data will be monitored every day by the medical team, which will be fully available for any questions or concerns patients may have.

Official Title
-----------------
Daily Monitoring of Respiratory Symptoms and Spirometry During ETI Treatment in Persons With Cystic Fibrosis.

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: Elexacaftor 100 MG / Ivacaftor 75 MG / Tezacaftor 50 MG, 2 tablets each morning + Ivacaftor 150 mg one tablet each evening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cystic fibrosis diagnosis At least 12 years old Carrier of at least one copy of F508del mutation Ability to perform reliable and reproducible spirometry Medical and psychological stability written consent owning a smartphone Exclusion Criteria: Lung transplant FEV1 > 120 % pr (%GLI) at the inclusion test Pulmonary exacerbation

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CF patients before (3 days) and during (14 days) ETI treatment<br>Patients over 12 years old and eligible will start ETI treatment ( current standart treatment). Morning: Elexacaftor 100 mg, Tezacaftor 50 mg, Ivacaftor 75 mg, 2 tablets Evening: Ivacaftor 150 mg | Drug: Elexacaftor 100 MG / Ivacaftor 75 MG / Tezacaftor 50 MG, 2 tablets each morning + Ivacaftor 150 mg one tablet each evening<br>* Patients will daily perform home spirometry and complete a respiratory symptoms score before (3 days) and during (first 14 days) ETI treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 changes from baseline (3 days before treatment) to Day 14 under ETI | Daily home spirometry with Spirobank device, between 14H-20H, before nebulization and / or physiotherapy | 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory symptoms score changes from baseline (3 days before treatment) to Day 14 under ETI | Daily scoring unsing a respiratory questionnaire (8 questions); each item is scored 1 to 5 (worse score: 40) | 17 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elexacaftor, time course, FEV1, Respiratory symptoms
A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma and also to determine the safety of the combination.

Official Title
-----------------
A Phase II Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

Conditions
-----------------
Kidney Neoplasms

Intervention / Treatment
-----------------
* Drug: Thalidomide
* Drug: Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- Able to comprehend and sign an IRB approved Informed consent Willingness and ability to comply with the FDA-mandated S.T.E.P.S.® program. Male or female 18 years or older Willing to use contraception Pathologic diagnosis of renal cell carcinoma Bi-dimensionally measurable disease Evidence of disease progression prior to start of treatment Failed prior immunotherapy or unwilling/unable to receive prior immunotherapy Adequate hematologic data: ANC.1.5; platelets>100x10^9 Adequate renal function: Creatinine clearance .50cc Adequate liver function: Alkaline phos <3XULN AST/ALT <3XULN T.Bili <1.5XULN ECOG performance status 0-1 Exclusion Criteria:- Known brain metastases. Peripheral neuropathy. Pregnant and/ or lactating female. Unable to take a baby aspirin.

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: Thalidomide|nan|
|Drug: Capecitabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the combination |  |  |
Internet Delivered Self-help for Insomnia

Study Overview
=================
Brief Summary
-----------------
The current study aims to evaluate the effects of internet-delivered self-help CBT for insomnia through a randomised controlled trial. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be randomised into treatment groups or the waiting list. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Behavioral: Internet CBT self-help
* Behavioral: CBT self-help booklet
* Other: Waiting list


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Insomnia Access to the internet Exclusion Criteria: Alcohol or substance abuse Severe depression Being suicidal Sleep apnea Schizophrenic or having a psychosis disorder

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: internet CBT self-help<br>CBT via the internet | Behavioral: Internet CBT self-help<br>* Internet based Cognitive behavioral self-help method for insomnia<br>|
| Experimental: CBT self-help booklet<br> | Behavioral: CBT self-help booklet<br>* Cognitive behavioral self-help method for insomnia via booklet<br>|
| Active Comparator: Waiting list<br> | Other: Waiting list<br>* Waiting list<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Diary | Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety rating | Measured with the HADS | 1 year | 
| Depression ratings | Measured with the CES-D | 1 year | 
| Sleep medication | Measured in the daily diary log | 1 year |
Prognostic Impact of the Nutritional Status of Individuals Aged 70 Years and Older With SARS-CoV-2

Study Overview
=================
Brief Summary
-----------------
Mortality due to Covid-19 is much higher in the elderly. There are several reasons for the vulnerability of the elderly to the coronavirus: a less efficient immune system, underlying chronic conditions, less protected living conditions. They may also present a poor nutritional state and/or degraded metabolic reserves aggravating an underlying state of frailty. The prevalence of the risk of undernutrition in elderly patients with COVID-19 is high. The evolution of the nutritional status of people aged 70 years or older infected with SARS-Cov-2 is not yet well known. The prognosis of these patients could depend on their nutritional status at the time of the disease. In view of the lack of data, it would be interesting to compare the risk of mortality based on nutritional status in individuals with vs. those without COVID-19.

Official Title
-----------------
IPrognostic Impact of the Nutritional Status of Individuals Aged 70 Years and Older With SARS-CoV-2

Conditions
-----------------
SARS-CoV-2

Intervention / Treatment
-----------------
* Other: Data collection
* Other: Querying the INSEE database


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SARS-CoV-2 test positive (positive PCR test or evocative CT scan) or negative (with clinical suspicion of COVID, negative PCR test and non-evocative CT scan) Age ≥ 70 years old Hospitalization at Dijon University Hospital Person or legal representative has not stated their opposition to inclusion in the study after being informed Exclusion Criteria: Person subject to a measure of judicial safeguard Non-affiliated or non-beneficiary of national health insurance

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Data collection|from D0 to hospital discharge|
|Other: Querying the INSEE database|Vital status at 3 months and 12 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | to 3 months |
Aspirin Effectiveness Study

Study Overview
=================
Brief Summary
-----------------
Aspirin is an effective medicine for prevention of heart attacks in patients with coronary artery disease and works by preventing clots from forming. In previous studies aspirin has been found to be ineffective in between 2% and 65% of patients but none of these studies have looked specifically at coronary artery disease patients in Ireland. This study is being done to identify the percentage of patients in Ireland whose aspirin is not working effectively and help identify factors that could be used to target interventions to increase aspirin's effectiveness in Irish patients.

Official Title
-----------------
Aspirin Effectiveness in Coronary Artery Disease Patients in Ireland

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Patients with documented coronary artery disease Current treatment with any dose of aspirin daily for a minimum of 3 months Able to provide written informed consent based on competent mental status Exclusion Criteria: Myocardial infarction, unstable angina or stroke during the preceding three months Platelet count <125,000/mm Known haematological disorders Active malignancy on current chemotherapy or a recent diagnosis of cancer

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 |
| --- | --- |
| CAD patients<br>Representative sample of coronary artery disease patients receiving aspirin therapy for secondary prevention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with non-response to aspirin | Prevalence of non-response to aspirin in coronary artery disease patients in Ireland by measurement of serum thromboxane B2 | Following a minimum of 3 months of daily aspirin use | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Disease, Aspirin, Secondary Prevention
Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine whether the use of injectable osteoinductive/osteoconductive compounds (OOC) during Anterior Cruciate Ligament (ACL) reconstructive surgery, combined with an accelerated rehabilitation protocol (ARP) provides clinical outcomes superior to those attained via traditional ACL reconstruction and delayed rehabilitation protocols.

Official Title
-----------------
Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound

Conditions
-----------------
ACL Injury

Intervention / Treatment
-----------------
* Drug: OOC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any adult undergoing a surgical procedure for hamstring ACL reconstruction Exclusion Criteria: Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Surgery<br>Participants in this group undergoing standard of care reparative surgery will not receive additional intervention | |
| Experimental: Standard Surgery with OOC<br>Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention | Drug: OOC<br>* The OOC will be mixed with autologous 5cc of platelet rich plasma (PRP), and then injected using a syringe into both tibia and femoral tunnels<br>* Other names: StimuBlast;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Bone Tunnel Expansion | Number of participants will be classified with having femoral and tibial tunnel expansion as: minimal expansion (<1mm) mild expansion (<5mm) moderate expansion (5-10mm) large expansion (>10mm) as measured via Magnetic Resonance Imaging (MRI) | up to 12 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft Maturation | as measured in millimeters via Magnetic Resonance Imaging (MRI) | up to 12 months post-surgery | 
| Number of Participants With Tunnel Ganglion Cyst Formation | as measured via Magnetic Resonance Imaging (MRI) | up to 12 months post-surgery |
to Translate and Validate the TOPAS TORONTO PSORIATIC SCREENING QUESTIONNAIRE)Into Spanish

Study Overview
=================
Brief Summary
-----------------
TO TRANSALETE AND VALIDATE DE TORONTO PSORIATIC ARTHRITIS SECREENING QUESTIONAIRE INTO SPANISH

Detailed Description
-----------------
THIS IS PART OF THE COLOMBIAN REGISTRY OF PATIENTS WITH PSORIASIS AND PSORIATIC ARTHRITIS

Official Title
-----------------
TO TRANSLATE AND VALIDATE THE ToPAS (TORONTO PSORIATIC SCREENING QUESTIONNAIRE) FOR THE SCREENING OF PSORIATHIC ARTHRITIS PATIENTS IN DERMATOLOGY CLINICS

Conditions
-----------------
Psoriatic Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ADULT WITH PSORIASIS IN THE DERMATOLOGY CLINIC Exclusion Criteria: ADULT WITH OTHER AUTOIMMUNE DISEASE

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| The Kuder Richardson Coefficient of reliability (K-R 20) |  | 4 MONTHS |
Bupivicaine to Reduce Postoperative Pain in Laparoscopic Ventral Hernia Repair

Study Overview
=================
Brief Summary
-----------------
The investigators are testing to see if infusion of bupivicaine between the mesh and abdominal wall can reduce postoperative pain and decrease use of narcotics in the postoperative setting.

Detailed Description
-----------------
The primary objective of this study is to test different methods for pain management following laparoscopic ventral hernia repair. We hypothesize that local analgesic injection between the abdominal wall and mesh intraoperatively during laparoscopic ventral hernia repair will result in a 20% decrease in the use of post-surgery pain medication in the first four hours after surgery.

Official Title
-----------------
Intraoperative Local Anesthesia for Management of Postoperative Pain Following Laparoscopic Ventral Hernia Repair: a Prospective Double-blind Randomized Trial

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Bupivicaine Infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be scheduled for a laparoscopic ventral hernia repair at SBCH. If any additional procedure is performed, the subject will be excluded from the study Age 18 or older Patient must agree to complete pain journal postoperatively Informed consent signed and dated by patient. Consenting through a legally authorized guardian will not be accepted due to the necessity of completing a subjective pain journal Exclusion Criteria: Any surgical procedure occurring besides the study procedure Any allergy or sensitivity to bupivicaine or its derivatives Less than 18 years of age Patient unable to self report in pain journal due to cognitive disabilities Discharged less than 4 hours post-surgery

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivicaine Infusion<br>We will infuse bupivicaine between the abdominal wall and mesh to try and reduce postoperative pain | Drug: Bupivicaine Infusion<br>* Investigators and Caregivers will be blinded to either 0.9% Normal Saline or 0.5% Bupivicaine infusion between the mesh and abdominal wall<br>* Other names: Marcaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | We will measure pain based on pain journal and usage of postoperative pain medication | 24 hours |
Computed Tomography for Evaluating Supination-external Rotation Type Ankle Fractures

Study Overview
=================
Brief Summary
-----------------
To compare measures of ankle stability from an investigational cone beam computed tomography scanner to gravity stress X-ray in patients who have unstable supination-external rotation ankle fractures.

Official Title
-----------------
Comparison of a Novel Weight Bearing Cone-beam Computed Tomography (CT) Scan to Gravity Stress X-ray for Determining Instability of Supination-external Rotation Type Ankle Fractures

Conditions
-----------------
Supination-external Rotation Ankle Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: willing & able to provide written informed consent at least 18 years-old have medial clear space measuring less than 5 mm with clinical suspicion of instability and would normally require a gravity stress X-ray Exclusion Criteria: pregnant (females) prisoners open fracture clinical signs of foot deformity previous foot trauma or surgery on the affected foot significant osteoarthritis or pre-existing ligamentous instability or pain in the affected foot unable to stand in the weight bearing position during the CT scan

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 |
| --- | --- |
| Ankle fracture cases<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medial Clear Space Distance in the Ankle Joint | measured on weight bearing CBCT | Baseline- single-day study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medial Clear Space on Gravity Stress Xray |  | Baseline | 
| Medial Clear Space on Standard Xray |  | Baseline |