cyrilzakka/clinical-trials huggingface dataset:
Cardiac (CMRI) Assessment of Acromegaly

In this study, the investigators will evaluate the cardiac structure and function, focusing on the myocardial water content and interstitial fibrosis, in patients with active acromegaly in comparison with 1) healthy volunteers, 2) the same acromegalic patients that have received efficient therapy.

The investigators hypothesize that the myocardial water content in acromegaly is increased as these patients present with sodium and water retention and that this myocardial water infiltration will improve with efficient treatment of the disease. They will thus assess using CMRI, this parameter by measuring the myocardial transverse relaxation time (T2), reflecting water content in the myocardium.

Patients with acromegaly have left ventricular (LV) hypertrophy and dysfunction on echocardiography, but only very few studies have been performed using cardiac magnetic resonance imaging (CMRI), currently the reference modality is assessment in cardiac geometry function. In addition, no data are available on right ventricular (RV) and atrial structure and function. The pathophysiology of the cardiac involvement in acromegaly may be related to increase myocardiac water content and/or interstitial myocardiac fibrosis.

The main objective of sthe study is to compare the myocardial water content in patients with acromegaly and in healthy volunteers. Secondary objectives of the study are to evaluate :

1. interstitial fibrosis and the structure and the function of LV and RV in acromegalic patients in comparison with healthy volunteers;
2. the reversibility of the cardiac involvement (water content, fibrosis, LV and RV structure and function) after efficient treatment of acromegaly;
3. the elasticity of aorta in acromegalic patients in comparison with healthy volunteers and with the post-treatment state. Twenty acromegalic patients will be included in order to dispose of 15 patients that will completed the study and the same number of age- and BMI-adjusted healthy volunteers will be included.

Eligibility Criteria:
Inclusion Criteria:

* Active acromegaly as defined by the usual diagnostic criteria (de novo patients or patients uncontrolled by previous treatments).
* Healthy volunteers matched for age, sex and BMI with the patients of the group 1

Exclusion Criteria:

* History of coronary heart disease (acute or chronic myocardial ischemia)
* Acute or chronic renal failure (creatinin clearance 30 mL/min/l,73m2)
* Contraindication of MRI
* Hypersensitivity to gadolinium
* Pregnancy
Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms

This is a multi-center, double-blind, randomized, placebo-controlled multiple ascending dose study in post-menopausal women with vasomotor symptoms. Single ascending doses of NT-814 will be investigated in 4 cohorts. Each cohort will comprise of 20 subjects. Subjects will be dosed for 14 days.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal female subjects experiencing frequent moderate to severe hot flashes.Menopause will be defined as:

  * 12 months of spontaneous amenorrhea;
  * OR at least 6 weeks' post-surgical bilateral oophorectomy with or without hysterectomy.

Exclusion Criteria:

* BMI \> 35kg/m2.
* Any active comorbid disease, ECG or laboratory result deemed by the investigator to be clinically significant and which could impact safety during study conduct or that could interfere with the study evaluation, procedures or completion.
* Use of prohibited medications defined in the protocol.
* Inability or unwillingness to comply with study procedures or requirements.
Effect of a Nootropic on the Cognitive Performance in Young Adults

The main aim of this study is to determine the effect of a nootropic on cognitive performance (i.e., reaction time, inhibitory control, cognitive flexibility, working memory, neuro-psychological outcomes).

Cognitive decline is a worrisome consequence of normal or pathologic ageing, having a high personal, eco- nomic and societal burden; also, it could herald the onset of dementia which is associated with significant morbidity and mortality.

However, with a general increase in life expectancy and a corresponding increase in the prevalence of age-related cognitive impairment, there have been concerted efforts towards the development and adoption of preventive strategies that would minimize the risk of developing dementia, or reduce the rate of cognitive decline with ageing. In the last few decades, certain compounds have been found useful in the management of cognitive decline.

The term 'nootropic' has been used to define such substances with the capacity to enhance cognition. While research has led to the synthesis of several drugs with nootropic effects, attention is now being shifted to the discovery, characterization and utilization of nootropics from natural sources for the prevention and management of age-related cognitive decline.

25 young adults will be randomized into two conditions (nootropic and placebo conditions) with 48 hours of separation between conditions. 48h previous to the randomization the participants will perform a familiarization to avoid the learning effects.

Each evaluation day will conform to the following tests:

* Simple and multiple reaction time
* Inhibitory control
* Cognitive flexibility
* Working memory
* Creative intelligence
* Verbal fluidity
* Motivation
* Mood
* Positive and negative emotions
* Adverse effects

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female
* Ages 18-30 years
* BMI: 18-30.0 kg/m2
* Stable weight over the last 3 months (body weight changes\<3kg)
* Participant must be capable and willing to provide consent, understand exclusion criteria, instructions and protocols.
* To talk and to read Spanish fluently.

Exclusion Criteria:

* History of neurological disease or mental disease.
* History of cardiovascular disease
* Diabetes or hypertension
* Pregnant, planning to become pregnant, or breastfeeding
* Have been treated previously or during the study period with neurological drugs.
* Have been treated previously or during the study period with prescription drugs: antihypertensive, lipid lowering, acid uric lowering, glucose lowering, beta blockers or any drug that under the investigator's judged could influence the results.
* Allergy/intolerance to any ingredient of the nootropic.
* High caffeine consumes (\>300mg/day, or \>3 coffees/day).
* Any non-controlled medical condition which could influence results or could be worsened by the participation in the study.
* Are deemed unsuitable by the investigator for any other reason, that prevent data collection.
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis

The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules in active lupus nephritis participants. This study will assess Laquinimod doses of 0.5 milligrams (mg)/day and 1 mg/day in combination with standard of care treatment (mycophenolate mofetil \[MMF\] and corticosteroids). Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with SLE
* Kidney biopsy within 12 months prior to baseline with a histological diagnosis of proliferative or membranous Lupus Nephritis (LN)
* Clinically active Lupus Nephritis as evident by urine protein-to-creatinine ratio (UPCR) of 1 or higher, for LN classes III, IV, or class V in combination with classes III or IV, or a UPCR of 2 or higher for LN class V, at screening or any time between screening and baseline.

Exclusion Criteria:

* Participants with severe renal impairment or dialysis
* Participants with a clinically significant or unstable medical or surgical condition
* Women who are pregnant or nursing or who intend to be during the study period
* Women of child-bearing potential who do not practice an acceptable method of birth control NOTE: Other inclusion and exclusion criteria may apply.
A Study of the Effect of RO4917838 on the QTcF Interval in Healthy Volunteers

This multiple-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, parallel group study will investigate the effect of RO4917838 on the QTc interval in healthy volunteers. Healthy volunteers will be randomized to one of 4 treatment arms; Arm A: low dose of RO4917838, Arm B: high dose of RO4917838, Arm C: placebo to RO4917838 and moxifloxacin on Day 1, Arm D: placebo to RO4917838 and moxifloxacin on Day 11. The anticipated time on study treatment is 11 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged 18 to 65 years inclusive
* Body mass index (BMI) between 18 and 30 kg/m2 inclusive.
* Have no contraindications from the following: a detailed medical and surgical history, and a complete physical examination
* Able to participate, and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria:

* History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, mental, cardiac, vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis.
* History of alcohol and/or drug abuse or addiction within the last 2 years prior to Day 1 of the study.
* Consumption of nicotine and/or tobacco containing products within the last 3 months prior to Day 1 of the study.
* Infection with human immunodeficiency virus, hepatitis B and/or hepatitis C
* Any condition or disease detected during the medical interview / physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator.
* Positive drug screen or alcohol test at screening or prior to enrollment.
* Coffee or tea consumption \> 10 cups per day or methylxanthine containing drinks \>1.5 liter/day or more than 250 g/day of chocolate.
* Alcohol consumption averaging \> 3 drinks daily
Efficacy of Paxman Scalp Cooling to Prevent Chemo Induced Alopecia in Black Patients With Breast or GYN Cancers

This study will measure the efficacy of scalp cooling with the Paxman Scalp Cooling (PSC) device in a diverse patient population with success measured as prevention of more than 50% hair loss during chemotherapy. We propose that scalp cooling has distinct efficacy in participants with black or ethnic-minority hair types due to differences in textures, hair thickness. This study will examine the success rate of scalp cooling in black patients receiving chemotherapy for breast or gynecological cancer.

The primary objective is to measure the efficacy of the PSC device in preventing CIA in this diverse patient population with success measured as prevention of \>grade 2 alopecia by self-report using the modified Dean scale or the VAS scale in \>50% of participants using the intervention. We propose that scalp cooling has distinct efficacy in participants with black or ethnic-minority hair types due to differences in textures, hair thickness.

The study aims include delivery of scalp cooling at each chemotherapy cycle with measurements of CIA at assigned intervals using patient self-report measured by the modified Dean scale and the Visual Analog Scale (VAS) outlined below.

The secondary aims are provider assessments of alopecia as measured by the NCI grading scale of alopecia, adverse effects of scalp cooling procedures such as headaches, dizziness, and pain, reasons for refusal or drop-out of study intervention.

Psychosocial and quality-of- life (QOL) effects of CIA in study participants will be measured using patient reported outcomes. The EORTC QLQ-B45 and Chemotherapy-Induced-Alopecia-Distress Scale (CADS) will be administered at designated time intervals.

Eligibility Criteria:
Inclusion Criteria:

* Stage I-III breast cancer patients
* Stage I-III endometrial cancer patients
* Stage I-III ovarian cancer patients
* Self-identified as black: African, African-American, or Caribbean black are included . Patients of mixed race who identify as black are also included.
* Planned for \>4 cycles of chemotherapy in the neoadjuvant or adjuvant setting with curative intent
* At least one chemotherapy agent being a taxane.
* Ability to read and answer questions in English
* Ability to sign informed consent for themselves.
* Able to fit into one of available cap sizes

Exclusion Criteria:

* Metastatic cancer patients
* Patients who do not self-identify as black (see definition above)
* History of cryoglobulinemia or cold agglutin disease
* Prior chemotherapy
* Non-taxane chemotherapy regimens (anthracycline based chemotherapy regimens are eligible for breast cancer patients)
* Baseline alopecia
* Concurrent medications to prevent hair loss
* Cold urticaria and cold- induced anaphylaxis
* Unable to fit into an available cap size
* Adults unable to consent on their own will not be eligible
* Individuals unable to answer questionnaires in English will not be eligible.
* Pregnant women will not be permitted to enroll as the use of this device in pregnancy is not well studied
* Prisoners will not be included in this study.
Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study

The objective of this study is to assess the safety and efficacy of the Quartet™ lead and Promote Q® device system in a patient population indicated for cardiac resynchronization therapy.


Eligibility Criteria:
Inclusion Criteria:

* Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or lifethreatening ventricular tachyarrhythmia(s)
* Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement.
* Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

* Have had a recent CVA or TIA within three months of enrollment
* Have a contraindication for an emergency thoracotomy
* Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
* Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months
* Have undergone a cardiac transplantation within 40 days of enrollment
* Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA, Stent or CABG) within 40 days of enrollment
* Are currently participating in a clinical investigation that includes an active treatment arm
* Are pregnant or planning to become pregnant during the duration of the study
* Have a life expectancy of less than 6 months due to any condition
* Are less than 18 years of age
* Are unable to comply with the follow up schedule
The Inotrope Evaluation and Research Patient Registry

The INTERPRET Inotrope Evaluation and Research Patient Registry is a longitudinal, observational study designed to look at the demographics and outcomes of heart failure patients on inotropic therapy administered in the home or infusion suite setting. The data gathered in this registry will provide information on how a patient's quality of life and symptoms change over time while on inotrope therapy, and help healthcare providers to have a better understanding of the benefits and risks associated with bridge-to-treatment and palliative care.

Eligible patients will be consented by the site investigator or staff to participate in the Registry at the time of referral for home care. Clinical data, including dosing, symptom severity, lab values, and hospitalizations, along with data on quality-of-life and patient compliance with treatment, will be collected by the home care nurses and pharmacists. The Registry's goal is to significantly contribute to the medical understandings of heart failure treatment and to improve the quality of care for heart failure patients in the United States through active publication of registry findings and disease management approaches.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be prescribed inotropic treatment (milrinone, dobutamine or dopamine)
* Patient must be referred to Coram for this treatment in an alternate site of care, either home or infusion suite
* Patient must be willing to receive care and comply with the teaching and training necessary to administer treatment
* Patient is age 18 or over

Exclusion Criteria:

* Patient is unable to start, or stops taking, inotropic medication
* Patient and/or patient insurance will not cover cost of home inotropic treatment with Coram, or patient elects not to start treatment
* Patient is under the age of 18
A Study in Patients with Mixed Dyslipidemia

A Phase 2 in Patients With Mixed Dyslipidemia

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Subcutaneously Administered BW-00112 in Patients with Mixed Dyslipidemia

Eligibility Criteria:
Inclusion Criteria:

1. Must have given written informed consent and be able to comply with all study requirements.
2. Males or females aged 18 to 75 aged years, inclusive, at the time of informed consent
3. Fasting LDL-C ≥ 70 mg/dL \[1.8 mmol/L\] at Screening.

4.150 mg/dL \[1.7 mmol/L\] ≤ fasting TG \< 500 mg/dL \[5.6 mmol/L\] at Screening, which may be repeated once if deemed necessary.

5.On a stable statin for at least 1 month before Screening and plan to remain on the same medication and dose for the duration of the study.

6.Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal 7.Male patients agreeing to use acceptable methods of contraception

Exclusion Criteria:

1. Active pancreatitis within 12 weeks prior to Day 1.
2. Clinically significant acute cardiovascular even or procedure
3. HbA1c \> 9.0% at Screening or patients with diabetes who have experienced diabetic ketoacidosis, diabetic decompensation, hyperosmolar hyperglycemic nonketotic coma, diabetes complications, recurrent infections, or hospitalization related to poor glycemic control within 24 weeks prior to Day 1.
4. Presence of any clinically significant uncontrolled disease known to influence serum lipids or lipoproteins. NOTE: Patients on thyroid replacement therapy are eligible if the dosage of thyroxine has been stable for at least 12 weeks prior to Day 1.
5. Use of TG lowering medication , non-prescription dietary supplements or other cholesterol lowering medication 30 days prior to Day 1, other than statins and ezetimibe.
Predictive Markers of Response and Toxicity in Patients With a Haematological Malignancy Treated With Immunotherapy.

Immunotherapies have substantially improved the prognosis of patients with haematological malignancies. While clinical trial data suggest durable complete response rates, markers associated with non-response to treatment are still poorly described. The identification of predictive markers using demographic, physiologic, biologic, immunologic data as well as patients' treatment history, might enable the optimization of therapeutic sequences and the reduction of treatment toxicity.

This study aim to assess markers of toxicity and response following an immunotherapy in patients with a haematological malignancy using real life data.

It will allow the development of clinical and therapeutic benchmarks to guide medical decisions in relation to the therapeutic strategies to be implemented for patients benefiting from real-life conditions, in addition to the results obtained in randomized studies.


Eligibility Criteria:
Inclusion Criteria :

* adult \>or= 18 years old,
* Suffering from one of the following pathologies: Hodgkin's lymphoma, Diffuse large B-cell lymphoma, Mantle B-cell lymphoma, Acute myeloid leukemia, Acute lymphoid leukemia, Peripheral T-cell lymphoma,
* Patients treated wuth any of the following immunotherapy : nivolumab, pembrolizumab, brentuximab vedotin, axicabtagene ciloleucel, tisagenlecleucel, brexucabtagene autoleucel, gentuzumab ozogamicine, polatuzumab vedotin and blinatumomab,

Exclusion Criteria :

- Patients opposed to the collection of their personnal data
Phase IIb Study of STA-2 in Patients With Chronic Stable Angina

The objective of this study is to evaluate the dose-response of three different dose levels of STA-2 (900 mg daily, 1800 mg daily and 2700 mg daily for 42 days) versus placebo in patients with chronic stable angina.

The objective of this study is to evaluate the dose-response of three different dose levels of STA-2 (900 mg daily, 1800 mg daily and 2700 mg daily for 42 days) versus placebo in patients with chronic stable angina.

Treatment Group A:

150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)

Treatment Group B:

300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)

Treatment Group C:

450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)

Placebo Group:

Placebo capsule, 2 capsules t.i.d., after meal

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged ≧ 20 years;
2. Subjects weight \> 50 kg
3. subjects who had more than 50% coronary stenosis documented by catheterization or ever received coronary intervention;
4. The two ETT results at screening (Visit 1) and baseline (Visit 2) show greater than or equal to 1 mm ST-segment depression within exercise duration;
5. The difference in exercise duration between screening (Visit 1) and baseline (Visit 2) do not exceed 20% of the longer test;
6. Able to provide written informed consent.

Exclusion Criteria:

1. Subjects with pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months;
2. Subjects with heart failure (New York Heart Association class III or IV), uncorrected valvular or congenital heart disease, subjects who need digoxin or digitalis;
3. Subjects with any resting EKG abnormalities preventing the interpretation of ischemia as judged by the investigator;
4. Subjects with COPD requiring bronchodilators;
5. Subjects with impaired hepatic function (defined as AST or ALT \> 2X the upper limit of normal values), or impaired renal function (defined as serum creatinine \> 1.5 mg/dL), or diagnosis of any chronic renal/hepatic disease;
6. Subjects with documented evidence of gastroduodenal ulcer disease, gastrointestinal bleeding or other gastrointestinal disease within the preceding 3 months as judged by investigator;
7. Subjects who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with safety assessments during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, or hematological disease as determined by the clinical judgment of the investigator;
8. Subject with any conditions that could interfere the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stoke);
9. Female subjects of childbearing potential who:

   * are lactating;
   * have positive pregnancy test (urine) at V1;
10. Subject has received any investigational agent within 28 days prior to the first dose of investigational product;
11. Subjects who have had administered STA-2 in prior clinical trial.