cyrilzakka/clinical-trials huggingface dataset:
Nobori Dual Antiplatelet Therapy as Appropriate Duration

NIPPON trial is a prospective, randomized, trial comparing 6 and 18 months Dual Antiplatelet Therapy (DAPT) following Nobori stent deployment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects \> 20 years old
* Undergoing percutaneous intervention with Nobori deployment
* No contraindication to prolonged DAPT

Exclusion Criteria:

* Subjects absolutely necessitating continuous DAPT
* Planned surgery necessitating discontinuation of antiplatelet therapy after enrollment.
* Active pathological bleeding
* Status of cardiogenic shock at enrollment
* Pregnant women
* Life expectancy of \< 1.5 years
* Subjects unable to give informed consent
* Episode of stroke \< 6 months
* Subjects with allergies or hypersensitivity to material of coating, Biolimus A9, and antiplatelet drugs.
* Subjects treated with other kind of DES or BMS during the index procedure
* Previous intervention with DES \< 6 months.
* Study participation impractical per investigator judgment
Unsupported Arm Exercise and Breathing Strategy in Patients With Chronic Obstructive Pulmonary Disease

Controlling the way people with lung problems breathe during arm exercises may reduce their breathlessness during activities of daily living that require them to lift their arms (i.e. brushing their hair, putting groceries away on high shelves). The main aim of this study is to determine the effects of specific breathing strategies during arm exercise on dyspnoea in patients with chronic lung disease. Coordinating inspiration with the action of arm elevation will reduce dyspnoea during a rhythmic overhead arm activity


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of COPD including forced expiratory volume in one second \< 80% predicted normal
* presence of lung hyperinflation at rest

Exclusion Criteria:

* musculoskeletal or neurological condition which could adversely affect arm activity
Melatonin for Prevention of Post Stroke Delirium

Post stroke delirium is prevalent in 10-30% of all stroke patients. We aimed to investigate wether Melatonin 2mg may prevent post stroke delirium.


Eligibility Criteria:
Inclusion Criteria:

* all patients with stroke, TIA or ICH admitted to our stroke unit or intemdiate care unit
* Stroke / ICH /TIA onset \<= 48h

Exclusion Criteria:

* RASS \<=4
* severe dementia, psychosis or depression
Frailty Assessment in Elderly Patients With Acute Coronary Syndrome

Frailty is known as an independent risk factor for morbidity and mortality in older cardiac patients . It is an important factor on the cardiologist decision between conservative and invasive treatment in older patient with acute coronary syndrome, and is usually made subjectively by the cardiologist known in the literature as eyeball testing.

in this study the investigators will compare the cardiologists eye ball testing to objective frailty assessment based on Fried score and Edmonton frailty scale.

elderly patients admitted to Meir hospital with acute coronary syndrome will be assessed for frailty twice: the first frailty assessment will be a subjective eye ball testing made by the cardiologist, the second assessment will be an objective one based on Fried frailty score and Edmonton frail scale.

The cardiologist will not be aware of the objective frailty assessment result.

The eye ball testing will be compared to the objective frailty assessment (Fried score and Edmonton frailty scale).

Eligibility Criteria:
Inclusion Criteria:

* patient admitted to Meir hospital with acute coronary syndrome
* Age: 80 years old and older
* eligible for signing an informed concent

Exclusion Criteria:

* uncontrolled heart failure ( pulmonary edema or the use of iv diuretics)
* cardiogenic shock
* fever st elevation myocardial infarction
Structured Exercise Training Program Versus Hypocaloric Hyperproteic Diet in Obese Anovulatory Infertile Patients With PCOS

Lifestyle modifications are successfully employed in polycystic ovarian syndrome (PCOS) improving menstrual cycles and fertility. Unfortunately, the compliance over the time is very low. Recently, we have showed a high adherence to structured exercise training (SET) program in women with PCOS. The current study will be aimed to compare the efficacy of the SET program with a diet program on the reproductive function in obese anovulatory infertile PCOS patients.

Forty obese anovulatory infertile PCOS patients who wish to conceive will be allocated in two study-groups according to their desire: structured exercise training (SET) group (n. 20) will undergo a SET program, whereas diet group (n. 20) will undertake a hypocaloric hyperproteic diet. The duration of the study will be of 24 weeks. At baseline, after 12 and 24 weeks clinical, endocrine and metabolic evaluations will be performed in each patient and all reproductive events obtained throughout the study will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* PCOS
* Anovulatory infertility
* Obesity (BMI \>30)

Exclusion Criteria:

* Age \<18 or \>35 years
* Neoplastic, metabolic, hepatic, renal, and cardiovascular disorders or other concurrent medical illnesses
* Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia
* Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other drugs know to affect sex hormone levels, carbohydrate metabolism, or appetite
* Organic pelvic diseases, previous pelvic surgery, suspected peritoneal factor infertility, tubal or male factor infertility or sub-fertility
Maturation of the Autonomic Nervous System in Prematures

The purpose of this study is to try to evaluate the maturation of the autonomic nervous system in prematures.

To evaluate the maturation of the autonomic nervous system in prematures by using heart rate variability analyses.

Eligibility Criteria:
Inclusion Criteria:

* All prematures
Platelet Drug Trial in Coronary Disease Progression

To determine the effectiveness of the platelet inhibitor drugs dipyridamole and aspirin in reducing the angiographic progression of coronary artery disease over a five-year period and to test the predictive value of the platelet survival half-life in identifying patients with more rapid progression of coronary disease and development of its complications.

BACKGROUND:

Coronary atherosclerosis is the leading cause of death in this country and the developed countries of the world. Although modern coronary care units have resulted in a markedly decreased hospital mortality from acute myocardial infarction, especially in those patients who enter the hospital early, its overall impact is limited since two-thirds of patients who die from coronary disease do not reach the hospital. When the trial was initiated in 1979, new approaches to the medical treatment of coronary disease and its complications were needed with an effort directed towards prevention of its progression and prevention of its complications through medical therapy. This prevention could save significant health care dollars over the long-term especially if the need for aortocoronary bypass graft surgery and the incidence of myocardial infarction could be reduced. Early identification of the patient at risk of developing coronary disease or of those with early coronary artery lesions would allow a greater impact of any successful intervention therapy.

DESIGN NARRATIVE:

Randomized, double-blind. The patients in the experimental group were treated with dipyridamole and aspirin for five years. Patients in the control group received a lactose placebo. The primary endpoint was angiographic evidence of progression of coronary artery disease and development of new coronary disease. Secondary endpoints included total mortality, cardiac mortality, mortality due to myocardial infarction, and incidence of new myocardial infarction. Recruitment ended in December 1982.

The study completion date listed in this record was obtained from the statement immediately above ("Recruitment ended in December 1982") and was confirmed from the Query/View/Report (QVR) System.

Eligibility Criteria:
Patients aged 65 or less. Angiographically identified coronary heart disease
HIV Engagement and Adolescent Depression Support (HEADS-UP)

This pilot study will individually randomize 105 adolescents living with HIV 1:1:1 to standard of care, adapted intervention, or enhanced intervention. The intervention is called the Friendship Bench Intervention is a counseling intervention for depression and engagement in HIV care.

Sub-Saharan Africa is home to the largest population of adolescents living with HIV (ALWH). Engaging ALWH in HIV care is challenging and reflected in lower rates of viral suppression and higher rates of loss to follow-up as compared to adults in the region. Depression has been identified as a significant barrier to initiating and remaining in HIV care. Indeed, this is the case for ALWH in Malawi where estimates of viral suppression range from 40%-78% and estimates of depression range from 18-26%. Resource-appropriate interventions that improve depression and address engagement in HIV care for ALWH are urgently needed.

The Friendship Bench (FB) is an evidence-based depression counseling intervention delivered by trained, supervised lay health workers. It is proven to reduce depression in the general population in low-resource settings but has not been adapted to be youth-friendly or enhanced with peer support to facilitate engagement in HIV care among ALWH. FB is based on problem-solving therapy, which offers an ideal framework for youth-friendly adaption and integration of retention peer support into a proven depression treatment model.

The long-term goal of the study team is to adapt, test, and scale up resource-appropriate interventions to reduce depression and improve engagement in HIV care amongst ALWH. The specific aims are: 1) to conduct formative research for youth-friendly adaptation and peer support enhancement of FB; 2) to adapt the evidence-based FB protocol to meet the developmental and contextual needs of ALWH and enhance this adapted FB protocol with peer support to facilitate HIV care engagement among ALWH; and 3) to determine the feasibility, fidelity, and acceptability of the Adapted and Enhanced FB protocols to improve depression and engagement in HIV care among ALWH. For the latter, a 3-arm individually randomized pilot study will be conducted to compare the adapted FB and the enhanced FB to standard care. The proposed aims pave the way for a R01 application to test the adapted and enhanced Friendship Bench interventions in a cluster randomized controlled trial and represent an important step forward towards improving depression among ALWH.

Eligibility Criteria:
Inclusion Criteria:

* age 13-18
* diagnosed with HIV (vertically or horizontally)
* scored ≥ 13 on the self-reported and previously used BDI-II
* living in the clinic's catchment area with intention to remain for \> 1 year
* willing to provide consent (age 18 or 16-17 years old and married (emancipated minors per Malawi law) or assent with parental consent (age 13-17)

Exclusion Criteria:

* Less than 13 or greater than 18 years of age
Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response

This will be a randomized, double-blind, placebo-controlled study. The study will use a three-period, six-sequence, complete-block, cross-over study design to characterize two doses of inhaled TD-8236 compared to placebo in subjects with mild asthma and a known response to an allergen. Each of the three periods will be 14 days, followed by a washout period before the next period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 65 years of age
* Willing and able to give informed consent and comply with study requirements
* Documented physician-diagnosed asthma for ≥ 4 months prior to Screening
* Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 at Screening and weighs ≥ 50 kg at Screening.
* Women of child bearing potential must have a negative pregnancy test
* Males and females must use a highly efficient birth control method
* Pre-bronchodilator FEV1 ≥ 70% predicted
* Documented allergy to at least one common allergen
* Dual responder to inhaled bronchial challenges
* Additional inclusion criteria apply

Exclusion Criteria:

* Positive for hepatitis A, B or C, HIV or tuberculosis
* Clinically significant abnormalities of laboratory evaluations
* Have abnormal ECG measurements
* Any sign of respiratory tract infection within 6 weeks of screening
* Have a current bacterial, parasitic, fungal or viral infection
* History of life-threatening asthma
* Uses or have used tobacco or nicotine-containing products within 6 months prior to screening
* Additional exclusion criteria apply
Metyrosine (Demser®) for the Treatment of Psychotic Disorders in Patients With Velocardiofacial Syndrome

This is an exploratory clinical investigation. The objectives of this study are to evaluate the safety, steady-state pharmacokinetics, and efficacy of metyrosine (Demser®) for the treatment of psychosis in patients with velocardiofacial syndrome (VCFS).


Eligibility Criteria:
Key Inclusion Criteria:

1. Females of childbearing potential cannot be at risk of pregnancy during the study.
2. Genetically confirmed diagnosis of VCFS at the time of screening.
3. Must have one of the following Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision (DSM-IV TR) diagnoses (applicable based upon clinical assessments): schizophrenia, schizoaffective disorder, psychosis not otherwise specified (NOS), bipolar disorder, or mood disorder with psychotic features.
4. A total PANSS composite score \>65.
5. Willing to discontinue psychotropic medications. -

Key Exclusion Criteria:

1. Evidence of acute suicidality.
2. Known or observed clinically significant cardiovascular, pulmonary, renal, hepatic, or gastrointestinal disorders; other clinically significant psychiatric/neurological and sleep disorders by DSM-IV-TR criteria; endocrine, or hematological or metabolic diseases.
3. Full scale IQ of less than 50.
4. Pregnancy.
5. Not using a reliable means of contraception.
6. Systolic blood pressure of ≤110 mm/Hg or ≥160 mm/Hg, diastolic blood pressure ≤60 mm/Hg or ≥90 mm/Hg, or has clinically symptomatic orthostatic changes.
7. QTcF \> 450 msec, or PR \> 250 msec, or QRS \> 110 msec on ECG.
8. History of seizure disorder. -
Pilates Method and/or Photobiomodulation in Women With Stress Urinary Incontinence

The present study is a clinical intervention applied to patients with urinary incontinence, with the intention of verifying the effects of the Pilates method associated or not with photobiomodulation with static magnetic field. The sample will consist of women with stress urinary incontinence from Bento Gonçalves attended at the school clinic of Faculdade Cenecista de Bento Gonçalves.


Eligibility Criteria:
Inclusion Criteria:

* Women between 30 and 60 years old;
* Present a clinical diagnosis of SUI;
* The patient must be available at pre-scheduled times for a period of 12 weeks, with full participation;
* The participant must agree with the methodology proposed by the project and, if so, must sign the TCLE as legal proof of their participation.

Exclusion Criteria:

* Patients with urge urinary incontinence;
* Constant flow urinary incontinence and stress urinary incontinence during the gestational period (because these are possible transitory cases due to pregnancy);
* Women who have difficulty in understanding;
* Patients who have more than one absence per month during the interventions.
A Study of Bevacizumab (Avastin) in Combination With Neoadjuvant Treatment Regimens in Participants With Primary Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer

This study will evaluate the effect of bevacizumab in combination with chemotherapy or endocrine therapy, as preoperative treatment, in participants with HER2 negative breast cancer. Participants will be randomized to receive either chemotherapy (FEC100: Epirubicine 100 milligrams per square meter \[mg/m\^2\], 5-fluorouracil 600 mg/m\^2, and cyclophosphamide 600 mg/m\^2\] for 12 weeks followed by taxane (paclitaxel/docetaxel) for 12 weeks or endocrine therapy (an aromatase inhibitor\] daily for 24 weeks) with or without bevacizumab (15 milligrams per kilogram \[mg/kg\] as intravenous \[IV\] infusion every 3 weeks up 24 weeks).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed, HER2-negative, men or pre- or post-menopausal women with primary operable adenocarcinoma of the breast, greater than or equal to (\>=) 2.5 centimeters (cm) in size
* Eastern Cooperative Oncology Group (ECOG)/world health organization (WHO) performance status less than or equal to (\</=) 2
* Normal baseline cardiac function (Left Ventricular Ejection Fraction \[LVEF\])

Exclusion Criteria:

* Stage IV (metastatic) disease
* Previous treatment for localized breast cancer less than (\<) 24 months from diagnosis of present breast cancer
* Other previous or current cancer except for basal cell cancer or in situ cervical cancer
* Current or recent use of aspirin (greater than \[\>\] 325 milligrams per day)
* Clinically significant cardiovascular disease
Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond

The objective is to compare two types of wound closure after total shoulder arthroplasty to determine which closure is faster, and subsequently if there are different outcomes between the two types of closures.

The objective of this study is to compare two types of wound closure after total shoulder arthroplasty procedures. A single fellowship trained shoulder surgeon will perform all procedures. It is hypothesized that participants who undergo an 2-Octyl Cyanoacrylate (OCA) mesh closure will have a faster closure time, lower cost, non-inferior complication rate, and non-inferior satisfaction scores with respect postoperative follow up and scar appearance.

Participants in the OCA mesh cohort will be compared to participants who have a closure with a running monocryl suture and dermabond. This investigation seeks to determine if OCA closure mesh closure is non-inferior to monocryl suture and dermabond in terms of operative time, cost, complications, and aesthetic appearance.

If the hypothesis is confirmed, this study will suggest that a OCA mesh closure may be used for total shoulder arthroplasty surgeries as an alternative to current conventional closures and may provide a cost benefit.


Eligibility Criteria:
Inclusion Criteria:

* Total shoulder arthroplasty
* Reverse total shoulder arthroplasty
* Age 18-100
* Single Surgeon

Exclusion Criteria:

* Previous shoulder surgery
* Known wound healing complications
* DM, chronic steroid use, vascular insufficiency, morbid obesity (BMI\>40), ESRD, family hx of pathologic scars
* Patients on blood thinners (ASA 81mg ok)
* Connective tissue disease
* Allergy to skin adhesive
* Mentally unable to complete questionnaires
* Previous wound over planned incision
High Field Magnetic Resonance Spectroscopy Imaging for Follow Up of Prostate Cancer Post Brachytherapy Implantation

The purpose of this study is to establish the correct scanning parameters for obtaining good quality 3 Tesla (3T) magnetic resonance spectroscopy images (MRSI) of the prostate gland before and after brachytherapy implantation for prostate cancer. Three Tesla MRSI may be a valuable additional diagnostic and follow-up investigation for prostate cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Suitable candidate for prostate brachytherapy to treat prostate cancer
* Patient signs a study consent form

Exclusion Criteria:

* Have received other radiotherapy for prostate cancer or hormone treatments
* Has contraindication to MRSI scanning
* Does not sign study consent form
Long Term Special Drug Use Investigation of Mepolizumab

This study is a special drug use investigation program of NUCALA (a brand name for Mepolizumab) administered subcutaneously (SC). In this study the information regarding the safety and effectiveness of long term use of NUCALA after subcutaneous injection will be collected from Asthma subjects in daily clinical practice. The observation period per subject will be 52 weeks from the initiation of NUCALA treatment with follow-up investigation for 2 years after the observation period. NUCALA is a registered trademark of the GlaxoSmithKline \[GSK\] group of companies


Eligibility Criteria:
Inclusion Criteria:

* Subjects receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications)

Exclusion Criteria:

* No exclusion criteria
Development of Appetite Measuring Tool and Appetite Status of Stunted Children

This study will provide a tool for researchers to measure important outcomes in relation to trial of intervention to reduce or prevent stunting.

Hypothesis: We assume that appetite score will be associated with improvement in growth and development parameters of children given the nutrition and psychosocial stimulation intervention

Objectives:

To explore maternal perception regarding childhood stunting To develop and validate an appetite measuring tool To assess the appetite status of young children To examine the relationship between appetite score, growth and development, potential biomarkers of appetite, child food intake and intestinal inflammation of the children.

Methods: In the first phase, a qualitative study will be conducted to explore maternal perception regarding childhood stunting and to develop a tool- the "Early Childhood Appetite and Satiety Tool"(ECAST) using mixed method approach (qualitative and quantitative). In the second phase, a community-based trial will be conducted with 50 stunted children of aged 12-18 months, living in urban slums of Dhaka, and 50 age-sex matched control children (non-stunted).

The stunted children will receive an intervention package which includes food supplementation (FS) with one egg and 150 ml of whole milk supplementing the usual home diet, 6 days a week for 3 months; psychosocial stimulation (PS) for 6 months, and routine clinical care monthly for 6 months. The control children will receive routine clinical care but no FS and PS. Routine clinical care includes micronutrients powder, de-worming, health and nutrition education and immunization. All children will be assessed for appetite score (ECAST score) and anthropometry-at baseline then monthly for 6 months; food intake at baseline then monthly for 3 months, and cognitive development using Bayley Scales of Infant and Toddler Development, third version (Bayley-III) on enrolment and at 3 and 6 months of enrolment. Blood samples will be collected to examine gut hormones, complete blood count and haemoglobin percentage.

Stool samples will be collected for routine examination and stool biomarkers. Urine sample will be collected for screening urinary tract infection. All the specimens will be collected at baseline and at 3 and 6 months of enrollment.

Outcome measures/variables:

The primary outcome:

Assessment of appetite score of stunted children aged 12-18 months compared to non-stunted children.

The secondary outcomes are:

-Association of appetite score with growth and development with potential biomarkers of appetite with child food intake and intestinal inflammation of the children.

Eligibility Criteria:
Inclusion Criteria:

* 50 stunted children (LAZ\<-2) aged 12-18 months
* 50 non-stunted (LAZ≥-2) aged 12-18 months

Exclusion Criteria:

* Severe acute malnutrition (SAM)
* Chronic illness
* Congenital anomaly/developmental delay/oromotor dysfunction