cyrilzakka/clinical-trials huggingface dataset:
The Combination of Palbociclib With ddEC-P as Neoadjuvant Therapy in Triple Negative Breast Cancer

This study will look at effects the combination of palbociclib and dose-dense neoadjuvant chemotherapy may have on triple negative breast cancer tumours which have not yet been treated.

Patients will be randomized to one of two treatment arms (1:1 ratio). Dose-Dense neoadjuvant chemotherapy in the first 8 weeks of will be: epirubicin (90mg/m2) and cyclophosphamide (600mg/m2), followed by paclitaxel (80mg / m2) after 8 weeks, cycled every 14 days for total 8 cycles.

Palbociclib will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week \[28 days\] cycle.

Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.

Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.

Note:

Following completion of study therapy, surgery will be scheduled for 18-20 weeks post-randomization.

Post-surgical treatment will be at the discretion of treating clinician, following postoperative pathology.

After week 16 (end of study therapy) all patients should continue Palbociclib for one year.

Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).

Eligibility Criteria:
Inclusion Criteria:

1. female patients, 18 years ≤ age ≤ 80 years；
2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
3. Histologically confirmed invasive breast cancer（early stage or locally advanced）
4. HER2 negative (HER2+/- by IHC or FISH-)
5. Hormone receptor (ER and PR) negative
6. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
7. Signed informed consent form (ICF)

Exclusion Criteria:

1. Metastatic disease (Stage IV) or inflammatory breast cancer
2. Previous or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix.
3. Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
4. Unable or unwilling to swallow capsules.
Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy

This study is a double-blind placebo-controlled trial evaluating the efficacy of raloxifene in the prevention of bone mineral density loss in patients receiving long term corticosteroids.


Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal patients with various chronic rheumatic diseases receiving chronic steroid therapy.
2. Stable disease for at least 6 months prior to study with a stable dose of steroid (prednisone \<= 10 mg/day or equivalent).
3. Baseline bone mineral density (BMD) of the lumbar spine T score \< -1.0.

Exclusion Criteria:

1. Patients with a history of thromboembolism.
2. Patients with positive antiphospholipid antibodies.
3. History of allergic reactions or intolerance to raloxifene or other SERMs.
4. Patients receiving bisphosphonates, parathyroid hormone, SERMs, anticonvulsants or anti-cytokine therapies within 6 months prior to study entry.
5. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
6. Patients with abnormal uterine bleeding of unknown etiology.
7. Patients with serum creatinine level of \>= 200 umol/L.
A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)

The objective is to determine the effect of Isoprinosine (inosine pranobex) in homosexual male patients with AIDS related complex (ARC) in delaying the onset of AIDS. Secondly, to determine the effect of Isoprinosine in decreasing the severity and/or incidence of lesser opportunistic infections and/or other conditions associated with ARC.


Eligibility Criteria:
Exclusion Criteria

Concurrent Medication:

Excluded:

* Cardiac glycosides.

Patients with the following are excluded:

* AIDS.
* Presenting with chronic candida infection-colo/rectal, oral/pharyngeal, cutaneous (finger/toenails) - for = or \> 3 months who have not responded to therapy.
* Critical illness.
* Hemophilia.

Prior Medication:

Excluded within 1 month of study entry:

* Steroids.
* Cytotoxic immunosuppressive agents.
* Radiotherapy and/or systemic antiviral medication.
* Immunomodulators (including Isoprinosine).

Prior Treatment:

Excluded within 1 month of study entry:

* Radiotherapy.

History of gout, uric acid urolithiasis, uric acid nephrolithiasis, or renal dysfunction.

* Lymphoid malignancy.

Homosexual male patients with AIDS related complex (ARC).

Current IV drug abuse.
Comprehensive Geriatric Assessment in Primary Care: A Randomised Feasibility Trial

The study aims to explore feasibility of implementing a tailored CGA to older adults with frailty and evaluate staff and patients perception of the intervention. In line with this, the objectives of the study are:

1. To assess applicability of finding older adults with frailty using eFI and delivering subsequent CGA and care planning at patients' home
2. To investigate staff and older adults' perception of CGA programme
3. To assess the health care resource usage and cost of the CGA programme
4. To measure key health related outcome domains including function, quality of life, loneliness, pain, falls and mobility.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 to 95 years
* eFI score \> 0.12

Exclusion Criteria:

* Do not meet criteria for frailty based on Gait speed, timed up and go test and PRISMA questionnaire
Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoproteinemia

The study is designed to evaluate the effect of Niacin/Laropiprant on postprandial lipoprotein metabolism, postprandial glucose metabolism, postprandial monocyte function, and postprandial biomarkers of endothelial dysfunction and inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects or postmenopausal female subjects aged between 19-70 years
* High risk patients (PROCAM risk ≥20%) on a stable statin-therapy, but at least simvastatin 20 mg/d
* HDL-cholesterol ≤50 mg/dl and /or triglycerides 150-400 mg/dl and/or LDL-cholesterol 70 - 150 mg/dl
* Lipoprotein (a) \< 30 mg/dl
* Patients may have normal glucose metabolism (normal HOMA), be insulin resistant (abnormal HOMA), have impaired fasting glucose or impaired glucose tolerance but not diabetes mellitus.
* Without niacin therapy for at least 6 months
* Dosage of any concomitant medication has been stable for at least 3 weeks
* If female, postmenopausal (absence of menstruation for at least 12 months or absence of menstruation \> 6 months with FSH \> 40 ng/ml respectively oestrogen \< 20 pg/ml)

Exclusion Criteria:

* Subjects with additional causes for hyperlipoproteinemia
* Diabetes mellitus or antidiabetic medication
* Subject has history of cardiovascular ischemia in previous 3 months or acute myocardial infarction or unstable angina
* History of psychiatric disorder or cognitive impairment that would interfere with participation in the study
* History of alcoholism
* Contraindication against niacin and/or laropiprant
* Subject has participated in an investigational study within 30 days prior to study initiation
* Fasting triglycerides \>400 mg/dl
* Life-threatening disease (e.g. cancer)
* Renal insufficiency (GFR ≤ 30 ml/min )
* Major hepatic impairment
* Known allergic reaction/intolerance against niacin and/or laropiprant
* Active peptic ulcer disease
Screening and Intervention for Glaucoma and Eye Health Through Telemedicine

This is a multiple site, randomized study that will assess the effects of personalized eHealth education and motivational-interviewing-based counseling on patient adherence to physician follow-up appointments.

The primary objective of this study is to evaluate the effects of personalized eHealth education and motivational-interviewing-based counseling on adherence to glaucoma follow-up care compared to standard education delivered by a trained staff member. Participants will be randomized in a 1:1 ratio to either standard education and care navigation or eHealth education, counseling and care navigation. The outcome measure of the participant seeing an Ophthalmologist for follow up care within 3 months was increased to 6 months. This modification was made due to ophthalmology visit appointments not being available within the 3-month timeframe.

This study is embedded in a CDC-funded program to engage people from medically underserved areas in glaucoma screening. Participants who screened positive for glaucoma or suspected glaucoma were randomized in a 1:1 ratio to either the standard education and care navigation arm or the eHealth education, counseling, and care navigation arm.

Eligibility Criteria:
Inclusion Criteria:

- \> or = to 18 years of age

Exclusion Criteria:

* Sudden vision changes
* Significant eye pain
* Pregnant women
* Prisoners
* Cognitive impairment
A Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects

This study to will compare the blood levels of sildenafil following administration of an experimental tablet vs. the conventional oral tablet.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males between the ages of 18 and 55 years.
* Body Mass Index of 18 to 30 kg/m2, and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Smoking in excess of the equivalent of 5 cigarettes per day.
* Treatment with an experimental drug within 30 days or sildenafil, vardenafil, tadalfil within 4 days before first study dose.
* Develop blood pressure lowering or experience dizziness, lightheadedness when going from the laying down position to standing position.
A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm

The purpose of this study is to determine whether participation in the Play and Learning Strategies (PALS) parenting intervention results in increased caregiver responsiveness behaviors and to test if participation in PALS results in increases in toddler skills and/or toddler neurological development.


Eligibility Criteria:
Inclusion Criteria:

- Maternal age over 18-years when child was born

Exclusion Criteria:

* presence of known/suspected congenital anomalies including chromosomal or complex congenital heart disease
* congenital infection including TORCH (Toxoplasmosis, Rubella, Cytomegalovirus, Herpes Simplex and others),untreated maternal HIV, or maternal syphilis
* bilateral grade 3/4 intraventricular hemorrhage,intraparenchymal hemorrhage, hydrocephalus
* Cerebral palsy with Gross Motor Function Classification of III or higher
* blindness-
* deafness
* Current maternal drug use or maternal drug use during pregnancy
* families who reside outside the catchment area (\>1 hour drive from the Texas Medical Center)
* Child with contraindication for MRI. If the mother of the child is pregnant, thinks she might be pregnant, or has a contraindication for MRI, another relative of the child will be asked to assist with the MRIs
Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma

The aim of this study is to confirm prospectively if the use of near infrared-indocyanine green (NIR-ICG) alone offers similar accuracy and sensitivity to the gold standard dual technique for sentinel lymph node detection in early stage vulvar cancer.


Eligibility Criteria:
Inclusion Criteria:

Adult women (18 years of age) with FIGO Stage IB (\> 1 mm depth of invasion) and small Stage II (4 cm) vulvar squamous cell carcinoma or cutaneous melanoma who are candidates for the Sentinel lymph node technique will be included (Negative clinical groin examination and/or imaging and primary unifocal vulvar tumor size of \< 4 cm).

Exclusion Criteria:

Women with a prior history of pelvic, vulvovaginal or inguinal radiation, with allergy or hypersensitivity to Technetium or ICG, or Bartholin gland cancer will be excluded.
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-01)

This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 mg compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.


Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
* Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
* Have no more than partial response (\< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
* If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Exclusion Criteria:

* DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
* Lifetime history of meeting DSM-5 criteria for:

  1. Schizophrenia spectrum or other psychotic disorder
  2. Bipolar or related disorder
  3. Major neurocognitive disorder
  4. Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
  5. Dissociative disorder
  6. Posttraumatic stess disorder
  7. MDD with psychotic features
* Significant suicide risk, as judged by the Investigator.
A Multiple Dose Study of LY3502970 in Healthy Participants

The main purpose of this study is to assess how fast LY3502970 gets into the blood stream and how long it takes the body to remove it when administered in multiple oral doses as new formulation compared to that of reference LY3502970 formulation. Information about safety and tolerability will be collected. The study is open to healthy participants. The study is conducted in two parts and it will last up to about 6 months, inclusive of screening period.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation.
* Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²).

Exclusion Criteria:

* Have an abnormal blood pressure and/or pulse rate as determined by the investigator -minor deviations acceptable to investigator are allowed
* Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) greater than 2X ULN (Upper Limit of Normal)
* Have an abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
* Are women of child-bearing potential
* Are women who are lactating
Longitudinal Studies of Blood Pressure in the Elderly

To study further the association between blood pressure mortality among those who participated in both the Hypertension Detection and Follow-up Program (HDFP) screen and the East Boston Established Populations for Epidemiologic Studies in the Elderly (EPESE) study.

BACKGROUND:

In middle-age, level of blood pressure (BP) is a strong and independent predictor of both total and cardiovascular disease (CVD) mortality. However, among the elderly, recent short-term observational studies, including the East Boston Established Populations for Epidemiologic Studies in the Elderly (EPESE), have raised the possibility of a J-shaped curve. In a study of short-term mortality, low blood pressures were positively associated with total and cardiovascular disease mortality. However, a further analysis confined to the 2079 (68 percent) of this cohort who were also screened nine years previously for the Hypertension Detection and Follow-Up Program showed the more conventional positive linear relationship between systolic blood pressure, and no association between diastolic blood pressure and mortality. The observations of higher short-term total and cardiovascular disease mortality at lower blood pressure levels among the elderly could have reflected a particular susceptibility to deleterious consequences of drug therapy for high blood pressure. Alternatively, such a finding might have been artifactual, due to survival bias or confounding by co-morbid conditions.

DESIGN NARRATIVE:

Linking data from the HDFP and the EPESE studies, the investigators examined change in blood pressure, antihypertensive medication use, and mortality over a 15-year period. With regard to the association between lower blood pressure and increased mortality, they determined whether the relationship previously observed reflected a fall from normotensive levels as opposed to a consistently low blood pressure. With regard to the upper end of the mortality curve, they assessed the effect of antihypertensive drug treatment on mortality as compared to those with untreated hypertension. The latter question had particular public health significance because questions remained about the risk-to-benefit ratio of antihypertensive drug treatment in this age group. Furthermore, they also described changes in blood pressure in this population and medication usage patterns over time and correlated type of medication and mortality.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions

Objectives: Occlusal surfaces of erupting permanent molars are highly prone to caries. Self-assembling peptide (P11-4) has proven to enhance biomimetic mineralization of early carious lesions. Aim of this study was to evaluate safety, clinical applicability and effect of using P11-4 (Curodont™ Repair) in non-invasive treatment of early occlusal lesions.

Methods: 70 patients with active early occlusal lesions (ICDAS-II:1-3) on first or second permanent molars at eruption will be allocated in this randomized, controlled, single blinded study to test (Curodont™ Repair+Duraphat®) or control (Duraphat®) groups.

Objectives: Occlusal surfaces of erupting permanent molars are high prone to caries. Self-assembling peptide (P11-4) has proven to enhance biomimetic mineralization of early carious lesions. Aim of this study was to evaluate safety, clinical applicability and effect of using P11-4 (Curodont™ Repair) in non-invasive treatment of early occlusal lesions.

Methods: 70 patients with active early occlusal lesions (ICDAS-II:1-3) on first or second permanent molars at eruption will be allocated in this randomized, controlled, single blinded study to test (Curodont™ Repair+Duraphat®) or control (Duraphat®) groups. Safety and applicability will be evaluated using dentist's/patient's questionnaires about adverse events, difficulties of application and satisfaction with procedure. Lesions will be assessed at baseline and recalls after 3 and 6 months regarding caries activity, clinical status (ICDAS-II) and with Diagnodent®. The Visual Analog Scale (VAS) of regression and of lesion size in addition to the Global Impression of Change Questionnaire will also be assessed. At every recall, fluoride varnish will be applied on lesions and patients received oral health instructions.

Eligibility Criteria:
Inclusion Criteria:

* Early occlusal carious lesions (without cavity) on permanent molar "6" or "7" at eruption which does not require an invasive treatment
* Age ≥ 5 years
* Size and form of the lesions: the lesions must both be fully visible and assessable and accessible
* Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study
* Written informed consent before participation in the study

Exclusion Criteria:

* Evidence of tooth erosion
* Fluoride varnish application \< 3 months prior to study treatment
* History of head and neck illnesses (e.g. head/neck cancer)
* Any pathology or concomitant medication affecting salivary flow or dry mouth
* Any metabolic disorders affecting bone turnover
* Concurrent participation in another clinical trial
Is the Routine Pressure Dressing After Thyroidectomy Necessary?

Thyroidectomy is an operation that is commonly performed. After an operation a pressure dressing by Hypafix is usually used due to the belief that it will help to reduce complications such as post-operative bleeding or haematoma. However, the practice is uncomfortable to patients and makes it hard to detect early haematomas.

We carried out a prospective randomised study to study the role of pressure dressing after thyroid surgery by evaluating the amount of fluids collected in the operative bed by ultrasonography compared with normal dressing.

Thyroidectomy is an operation that is commonly performed. In Department of Otolaryngology, Khonkaen University was performed this operation about 200 cases per years. After an operation a pressure dressing by Hypafix is usually used due to the belief that it will help to reduce complications such as post-operative bleeding or haematoma. However, the practice is uncomfortable to patients and makes it hard to detect early haematomas.

We carried out a prospective randomised study to study the role of pressure dressing after thyroid surgery by evaluating the amount of fluids collected in the operative bed by ultrasonography compared with normal dressing.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent thyroidectomy in Srinagarind hospital, Khonkaen University

Exclusion Criteria:

* Patients with cervical lymph nodes metastases requiring neck dissection
* Patients that tissue pathology shown anaplastic carcinoma
* Patients with clinical or laboratory indicators of coagulation disorders
Acute Time-Restricted Eating in Young Healthy Males

This study compared the metabolic response to three different eating windows (morning fast,12pm-8pm; evening fast, 8am-4pm; control, 8am-8pm).

Humans have evolved as a diurnal species, internally governed by the circadian system, which dictates our hormone regulation. 'Chrononutrition' is a sub-discipline which combines food timing with circadian physiology. The most popular method of time-restricted feeding in the UK is to skip breakfast. However, data from several meta-analysis have shown that skipping breakfast is associated with weight gain and insulin resistance, likely due to eating later into the evening/night and therefore, out of sync with our circadian rhythm. Recent research has shown that skipping dinner (evening fasting) has improved markers of cardio-metabolic health in clinical populations, although these are typically from longer-term studies. Despite these promising findings, it is not yet known whether these findings are population specific.

Therefore, the investigators are interested in examining the metabolic response pre and post-intervention to see whether these promising findings can translate into a healthy population. Furthermore, the investigators will be monitoring subjective appetite, energy intake, and expenditure to assess whether there is any short-term adaptation to a specific feeding window.

Eligibility Criteria:
Inclusion Criteria:

* recreationally active
* non-smokers
* non-dieting
* weight stable (self-reported for \>6 months)
* were not consuming any medication known to affect appetite or physical activity

Exclusion Criteria:

* Smokers
* \>10 hours per week physical activity
* Have dieted within the past 6 months
* Excessive alcohol consumption (\>14 units/week)
* Use of medication or supplements that may affect hormone concentrations.