cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Reproducibility of the Automated Measurement of the Extent of ILD on Chest CT

In interstitial lung disease (ILD), the extent of ILD on chest computed tomography (CT) is recognized as an important prognostic factor. Automated tools are now available to quantify ILD, but there is a lack of data on the reproducibility of this measurement and therefore its accuracy.

Therefore, the purpose of this study is to evaluate the variability of automated ILD quantification on chest CT. Reproducibility will be assessed by repeating chest CT scans and using different tools to measure the extent of disease.

In interstitial lung disease (ILD), the extent of ILD on chest computed tomography (CT) is recognized as an important prognostic factor. In recent years, several tools based on texture analysis or deep learning methods have been developed to provide rapid and accurate automated quantification of ILD extent.

An advantage of automated scoring methods is that they theoretically offer perfect repeatability of measurement. However, this is only true if the measurement is repeated on the same images. Several parameters can alter the appearance of the lungs on scanner images, such as the degree of inspiration or the reconstruction kernel used to reconstruct the images. There is a lack of data on the reproducibility of the whole process of automated ILD quantification and therefore its accuracy.

Therefore, the purpose of this study is to evaluate the variability of automated ILD quantification on chest CT.

Reproducibility will be assessed by repeating chest CT scans and using different tools to measure the extent of disease in patients with ILD from 2 institutions. Chest CT will be repeated the same day. This will allow assessment of the variability of automated measurement of ILD extent between 2 CT scans performed on the same day and when using different software. It will also allow to assess the variability of lung volume between the 2 CT scans and the effect of disease (idiopathic pulmonary fibrosis or connective tissue disease-related ILD) on the reproducibility of ILD quantification.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Known interstitial lung disease as part of idiopathic pulmonary fibrosis or connective tissue disease
* Followed in one of the participating hospitals
* Requiring a chest CT as part of a scheduled assessment
* Affiliated to a French national social security
* Informed consent

Exclusion Criteria:

* Acute exacerbation of ILD
* Pregnancy
* Inability to hold an apnea for 10 seconds
* Patients in the exclusion period after a previous research
* Need for additional procubitus or expiratory images
Internet Assisted Obesity Treatment Enhanced With Financial Incentives

The investigators propose a randomized controlled trial to evaluate whether the addition of financial incentives to a high-quality, online behavioral weight loss intervention produces better weight losses than the online treatment alone.

Overweight and obese but otherwise healthy participants (N=416) will be recruited in approximately equal numbers at two clinical centers, the University of South Carolina and the University of Vermont. Eligible participants will be randomized to one of two conditions: 1) an 18-month, 36-session group Internet behavioral weight control treatment (Internet Only) which replicates the intervention the investigators have implemented previously; or 2) the same 18-month, 36-session group Internet treatment plus financial incentives for performance of 3 key self-management behaviors (Internet+ Incentive). Both conditions will have access to the same web-based intervention platform and the same counselor-delivered intervention elements; the presence of economic incentives for behavioral and weight goals is the only difference between the conditions. Assessments will be conducted at Baseline, 2, 6, 12 and 18 months. Cost data will be collected to inform cost effectiveness evaluations.

Eligibility Criteria:
Inclusion Criteria:

* over 18
* BMI between 25 and 50
* Not currently pregnant or pregnant in the previous 6 months and currently breastfeeding or planning on becoming pregnant in 18 months
* Have a computer at home or at work with flashplayer, access to the internet, and a smart phone (to allow use of step counting aps)
* Free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
* Not enrolled in another weight reduction program
* Not currently on medication that would affect weight loss

Exclusion Criteria:

* had a heart attack or stroke in the previous six months
* had weight loss surgery
* lost 10 pounds or more in the previous 6 months
* currently taking medications for weight loss
* required by their doctor to follow a special diet (other than low fat)
* planning to move out of the area within 18 months
* schedule conflicts making it difficult to attend online "chats"
* live more than 60 minutes driving distance from either University of South Carolina or University of Vermont campuses
Weekly Topotecan Therapy in Patients With Ovarian Cancer

The purpose of this study is to find out the safety and feasibility of weekly topotecan consolidation therapy in patients with ovarian cancer.

Patients with Stage IIIC and IV optimally-debulked ovarian cancer will be treated with 6 cycles (every 3 weeks) of carboplatin (AUC 5) and paclitaxel (175 mg/m2). Patients who demonstrate a complete clinical response to this regimen will then be treated with topotecan consolidation (4 mg/m2 weekly x 8 weeks for one cycle followed by a break in the 9th week) for a maximum of 3 cycles. Primary endpoints will be toxicity and the determination of the appropriate dose, schedule, and duration of topotecan for further consolidation trials.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a histopathologic diagnosis of epithelial ovarian cancer.
* Patients must have completed front-line chemotherapy and be clinically NED (CA 125 \<35, negative CT scan, negative physical exam).
* Patients may have a second look laparoscopy, however, there must be no gross disease present (microscopic disease or pathologically negative).
* Patients must not have had other myelosuppressive therapy within four weeks of initiating topotecan therapy.
* Topotecan treatment must begin within 10 weeks following last cycle of initial chemotherapy.
* Patients may have had only one prior chemotherapy regimen.

Exclusion Criteria:

* Patients with a concomitant malignancy other than squamous cell or basal cell skin cancer.
* Patients who are pregnant or breast-feeding.
A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)

The purpose of this study was to evaluate the pharmacokinetics and safety of nemolizumab in adolescent participants with AD.


Eligibility Criteria:
Key Inclusion Criteria

* Male or female participants ≥ 12 to \< 17 years of age
* Chronic AD that has been documented for at least 2 years
* Eczema Area and Severity Index (EASI) score ≥ 16
* Investigator's Global Assessment (IGA) score ≥ 3
* AD involvement ≥ 10% of Body Surface Area (BSA)
* Documented recent history of inadequate response to topical medications
* Women of childbearing potential must agree to be strictly abstinent or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

Key Exclusion Criteria

* Body weight \< 30 kilogram (kg)
* Cutaneous infection within 1 week or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week
* History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, example., monoclonal antibody)
* Any medical or psychological condition, or any clinically relevant laboratory abnormalities that may have put the subject at significant risk according to the investigator's judgment
A Randomised Controlled Trial of Coenzyme Q10 in Patients With Schizophrenia and Schizoaffective Disorder

The study is a randomised placebo controlled trial of Coenzyme Q10 (CoQ10) vitamin supplementation in a sample of patients with schizophrenia or schizoaffective disorder. CoQ10 is produced in the mitochondria of our cells, and is involved in the production of energy. However, some people do not produce enough CoQ10, which can result in difficulties with concentration and memory, depressive symptoms, low energy levels and high blood pressure. The study will examine the impact of taking oral CoQ10 supplementation on patients with schizophrenia and schizoaffective disorder.

Coenzyme-Q10 (CoQ10) is an essential cofactor in the mitochondrial electron-transport-chain in addition to being a potent lipophilic antioxidant. Deficits in CoQ10 status have been linked to cardiovascular disease, cognitive decline, fatigue, and depression. CoQ10 supplementation may have a potential therapeutic value for patients with schizophrenia and schizoaffective disorder. This is a double-blind, placebo-controlled, randomised trial that will compare neurocognitive performance and symptoms of schizophrenia and schizoaffective disorder in participants randomised to active CoQ10 compared to scores from participants who received placebo. CoQ10 will be administered at a dose of 300mg/day, delivered in 3 doses of 100mg each. Participants will take CoQ10/placebo for 6 months. At three time points (baseline, 3 months and 6 months) each participant completes a neurocognitive and psychological battery of assessments. Blood pressure is monitored, and blood samples to assess mitochondrial function and plasma CoQ10 status are taken at each assessment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of schizophrenia or schizoaffective disorder

Exclusion Criteria:

* Current substance abuse
* History of epilepsy/seizures
* Head injury with loss of consciousness (\>3 minutes)
* Taking warfarin or blood thinning medication
* Uncontrolled thyroid dysfunction
Role of CGMS Usage in Predicting Risk for Hypoglycemia

This is a clinical study to examine rates hypoglycemia (self-report, EHR review, and review of values from a FDA approved continuous glucose monitoring system (CGMS)). Subjects will wear either blinded or unblinded CGMS. This is a 1:1 assignment with one group (50%) wearing 1 unblinded/1 blinded CGMS and the other group 50% wearing 2 blinded CGMS. The assignment will be computer based in a random fashion. Participants will continue with their usual diabetes management and glycemic monitoring profile as per usual. Those assigned to an unblinded CGMS can use the CGMS to manage their glucose levels at their own discretion. Individuals recruited will be those Type 2 diabetes who are deemed to be at high risk for hypoglycemia or low risk for hypoglycemia from a point score system established in an affiliated study.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* 18 years or older

Exclusion Criteria:

* Type 1 diabetes
* Current pregnancy or anticipation of pregnancy during study period
* At screening visit, HR\> 130 or SBP\>160 or DBP\>100 which remains present on recheck
Prospective Regional Epilepsy Database

PREDICT is an observational study following adults with an unprovoked seizure or epilepsy in the health care region of western Sweden. The objective is to identify biomarkers and/or genetic predisposition of relevance for diagnosis and/or treatment of epilepsy and study the long-term prognosis and consequences of epilepsy.

Adults over 18 years of age, with an unprovoked seizure in the last year or epilepsy, resident in the health care region of western Sweden (VGR) at the time of inclusion.

Baseline data and outcome variables are collected from several patient registries: the electronic medical records system in the health care region VGR and Swedish National Registers of healthcare, income, and employment managed by The National Board of Health and Welfare or Statistics Sweden, both of which are government agencies.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* An unprovoked seizure within the last year or a diagnosis of epilepsy according to the current International League Against Epilepsy definition (epilepsy with seizure in the last ten or antiepileptic drug treatment in the last five years)

Exclusion Criteria:

* Expected survival less than two years
* Inability to give informed consent
Feasibility of Ultra-sound Guided Radiofrequency Ablation in the Management of Head and Neck Neoplasia.

To study the feasibility of Radiofrequency ablation (RFA) via ultrasound guidance in the management of head and neck neoplasia.

The study evaluates the feasibility of radio-frequency ablation in the management of head and neck neoplasia.

Eligibility Criteria:
Inclusion Criteria:

* Patients with head and neck neoplasia.

Exclusion Criteria:

* When the patient does not meet the inclusion criteria.
* When the patient has a contra-indication of surgery or anesthesia.
* If the patient refuses involvement in the study.
Verapamil vs Steroid to Prevent Keloid Recurrence

Keloid scarring is a severe cosmetic and painful disease of the skin. The gold standard treatment is yet to be clarified. This randomized clinical pilot study will compare the effects of two local treatments for preventing keloid recurrence after surgical removal; steroid and verapamil.

Study hypothesis: Intralesional therapy with the calcium antagonist verapamil has equal treatment efficacy as steroid injection.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing surgical removal of keloid
* Patient 18 years old or greater
* Length of excisional scar after surgical removal of keloid between 2 and 10 cm

Exclusion Criteria:

* Keloid in face or hands
* Pregnancy or lactation
* Dementia
* Any heart or pulmonary condition
* Systemic treatment with beta-blockers, ACE-inhibitors or calcium antagonists
* Systemic corticosteroidal therapy
* Intralesional steroid treatment within 2 months of surgery to remove keloid
* Flap surgery
* Lesions to face, hands and other cosmetically sensitive areas
Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial of the Combined Lysis of Thrombus With Ultrasound and Systemic Tissue Plasminogen Activator (tPA) for Emergent Revascularization in Acute Ischemic Stroke

This is a randomized, placebo-controlled, phase 3 clinical trial to evaluate the efficacy and safety of transcranial ultrasound (US) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.

The primary objective of this trial is to provide information regarding the efficacy of a combined treatment with transcranial US and systemic tPA (Target group) compared to systemic tPA alone (Control group) in subjects with acute ischemic stroke. The primary efficacy endpoint is functional outcome at 3 months from stroke onset (modified Rankin Score ordinal shift analysis). The primary safety endpoint is the proportion of subjects in the Target vs Control group experiencing symptomatic intracranial hemorrhage (sICH) within 24 hours of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females 18 - 80 years of age
2. Subjects presenting within timeframe for intravenous tPA treatment approved by local regulatory authorities but no more than 4.5 hours from onset of symptoms
3. No signs of intracranial bleeding on assessment by non-contrast CT
4. Subjects with neurological deficits of a total NIHSS score ≥ 10 points
5. Subjects that in the opinion of the treating physician require treatment with full dose IV tPA as standard of care per institutional standards
6. SBP \< 185 mmHg and DBP \< 105 mmHg at baseline or after treatment of hypertension with medications prior to tPA bolus
7. Pre-morbid modified Rankin score of 0-1
8. Provision of informed consent as demonstrated by the subject's signature or by the signature of the subject's authorized legal representative on the Informed Consent Form in accordance with all local and national regulations
9. Co-signature on the Informed Consent Form by a qualified member of the study staff signifying that, in his/her professional opinion, informed consent has been obtained in accordance with all local and national regulations
10. For subjects in the optional arterial recanalization substudy:

    1. Occlusion located in the intracranial carotid tee through mid M2 or proximal A2, or intracranial vertebrobasilar or P1/proximal P2 segments or tandem lesions
    2. Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min for patients undergoing CTA or MRA

Exclusion Criteria:

1. Subjects with primary intra-arterial thrombolysis
2. Females who are pregnant or breast feeding
3. Subjects receiving other investigational drugs, procedures, or therapies within 30 days prior to study treatment
4. Subjects with any standard contraindication for intravenous tPA therapy
5. Significant concurrent medical/neurological conditions or test values that, in the opinion of the investigator, pose significant risk to the subject and warrant exclusion from the study
Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction

This study will look at how pacing your heart may assist your daily activities and how you are feeling.

RESET is a multicenter trial that will assess the effect of pacing in heart failure patients with a normal ejection fraction (or diastolic heart failure). The purpose of the RESET study is to evaluate the effect of pacing on exercise capacity and quality of life in this heart failure population.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are in sinus rhythm
* Patients who are on stable medical therapy
* Patients who exhibit signs and symptoms of heart failure, New York Heart Association (NYHA) Class II or III
* Patients who have experienced a hospitalization for decompensated heart failure; treatment for pulmonary congestion or volume overload; chronic treatment with a loop diuretic; or a brain natriuretic peptide (BNP) \> 125 ng/l.
* Left ventricular ejection fraction (LVEF) ≥ 50%

Exclusion Criteria:

* Patients with persistent atrial fibrillation or atrial flutter
* Patients who are in complete heart block
* Patients who have experienced a recent myocardial infarction (MI) or have unstable angina or require cardiac surgery or other procedures
* Patients who have severe heart valve disease or valve replacement
* Patients with a contraindication for a pacemaker system
* Patients who have a neuromuscular, orthopedic or other non-cardiac condition that prevents patient from exercise testing
* Patients who have infiltrative or hypertrophic cardiomyopathy
* Patients who have known severe pulmonary disease
* Patients with uncontrolled diabetes or blood pressure (systolic blood pressure (SBP) \> 160 mmHg or diastolic blood pressure (DBP) \> 95 mmHg)
A Study to Learn About the Safety of TALZENNA in People With Prostate Cancer.

The purpose of this study is to learn about the safety of TALZENNA in patients with BRCA mutation-positive metastatic castration-resistant prostate cancer. BRCA mutation positive means any changes to the BRCA gene. Metastasis means the cancer that has spread to other parts of the body. Castration-resistant prostate cancer means the prostate cancer that keeps growing even when the amount of male sex hormone in the body is reduced to very low levels. Prostate is a male sex organ.

The study is seeking for participants:

* with BRCA mutation-positive metastatic castration-resistant prostate cancer
* who have not used this study medicine before. All patients in this study will receive TALZENNA according to the prescriptions.

Patients will be followed up to 52 weeks (12 months) from the day of start of treatment start (Day 1). However, in cases where treatment has been completed or stopped less than 52 weeks (12 months) after the start of giving study medicine, the participants will be checked until completion (discontinuation) of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with BRCA mutation-positive metastatic castration-resistant prostate cancer
* No history of previous use of this drug

Exclusion Criteria:

* None
Pharmacological Intervention in Diabetic Retinopathy

The purpose of this study is to determine if diabetic retinopathy can be treated with prostaglandin analogues, prostaglandin synthesis inhibitors or carbonic anhydrases inhibitors.

Disturbances in retinal perfusion is believed to be involved in the pathophysiology of diabetic retinopathy. These disturbances may be due to changes in the basal diameter of retinal arterioles and to disturbances in the autoregulation of the diameter of these vessels when the blood pressure and the retinal metabolism changes. In vitro studies have shown that prostaglandins and carbonic anhydrases inhibitors are involved in the tone regulation of retinal arterioles, but it is unknown whether this finding is relevant in clinical practice. This can be tested in vivo by an retinal vessel analyzer measuring the dynamics of the retinal vessel diameter changes.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes type 1 with moderate diabetic retinopathy/healthy
* Blood pressure \< 135/85 mmHg

Exclusion Criteria:

* Eye disease (excluding diabetic retinopathy)
* Allergic
* Kidney disease
* Liver disease
* Severe asthma
* Heart disease
* Hypertension arterial
* Users of drugs that influence the metabolism of the prostaglandins in the carbon dioxide
* Pregnant and breastfeeding women and women who don't use secure contraception
* Persons who can't do without contact lens in the treated eye.
Iron Therpay and Fatigue in Women of Reprodcutive Age

For the assessment of anemia and then assessment of fatigue levels in non-anemic women followed by assessment of iron levels and intervention of iron and placebo


Eligibility Criteria:
Inclusion Criteria:

reproductive age non-anemic fatigued

Exclusion Criteria:

anemiac males