cyrilzakka/clinical-trials huggingface dataset:
"Quick-starting" of a New Combined Hormonal Contraceptive Pills, 15 mg Estetrol/3 mg Drospirenone VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition

The goal of this clinical trial is to learn if Estetrol/Drospirenone inhibit ovulation in quick-starting method. It will also learn about the safety of Estetrol/Drospirenone. The main questions it aims to answer are:

1. Does Estetrol/Drospirenone inhibit ovulation inferior to Ethinyl estradiol/Gestodene when starting on Day 7-9 of menstrual cycle?
2. What are the impacts of Estetrol/Drospirenone on ovarian activities when starting on Day 7-9 of menstrual cycle?
3. How does the cervical mucus change when starting Estetrol/Drospirenone on Day 7-9 of menstrual cycle?
4. What are the adverse effects when starting Estetrol/Drospirenone on Day 7-9 of menstrual cycle?

Researchers will compare Estetrol/Drospirenone to Ethinyl estradiol/Gestodene to see if Estetrol/Drospirenone inhibit ovulation in quick-starting method.

Participants will:

Take Estetrol/Drospirenone or Ethinyl estradiol/Gestodene starting on day 7-9 of menstrual cycle then every day for 1 pack of the pills.

Visit the clinic on day 1-2, day 7-9, and then every 2-7 days according to ultrasound finding (ovarian activities) until completing of pills to investigate

1. Transvaginal ultrasound
2. Cervical mucus
3. Serum hormonal profiles.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18 - 45 years old
2. Body mass index 18-30 kg/m²
3. Menstrual interval within 24 - 38 days
4. Absence of history of estrogen or progestin allergy and Absence of these compatibles with U.S. medical eligibility criteria category 3 - 4
5. Consent to use condom as contraception or have been sterilized

Exclusion Criteria:

1. History of estrogen, progestin or testosterone use within 3 months
2. Current pregnant or within 3 months of breastfeeding
3. Having ovarian cyst(s) or tumor(s)
4. Being a cervical cancer patient or having precancerous cervical lesion
Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers

Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound size reduction.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with colonised/ local infection in a venous leg ulcer or mixed leg ulcer with an ABPI ≥ 0,8 and \< 1.3
* A history of an appropriate compression therapy for at least 2 weeks prior to randomisation
* Subjects with colonised/local infection presenting with three of five following specified signs:

  * pain between dressing changes
  * exuding wounds
  * erythema on peri-wound skin
  * oedema
  * odour
* An ulcer size of at least 4 cm2 and a maximum size witch could be covered by one investigational product of 15x15 cm.
* Ulcer duration 6 weeks to 1 year
* In case of multiple ulcers: target ulcer must be at least 3 cm distant from other ulcers.
* Both gender with an age ≥ 18 years
* Signed informed consent

Exclusion Criteria:

* \> 10% necrotic (black) or fibrinous (yellow) tissue covering the wound bed
* Infected wounds in need of systemic antibiotic treatment
* Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days from inclusion on the wound intended to be included
* Previous treatment with silver product 2 weeks prior to inclusion
* Previous treatment with MepilexAg® on the target ulcer
* Use of systemic antibiotics for any reason during the previous 7 days
* Venous surgery 2 weeks prior to inclusion or planned surgery within 8 weeks after inclusion
* Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer/malignancy and severe anaemia) judged by the investigator to be a potential interference in the wound evaluation
* Subjects with poorly controlled diabetes mellitus i.e. HbA1c \>8%
* Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolon/day or equivalent. Subjects inhaling glucocorticosteroids for asthma should not be excluded.
* Known allergy/hypersensitivity to any of the components of the investigation products.
* Subjects with physical and/or mental conditions that are not expected to comply with the investigation due to poor medical condition
* Participation in other clinical investigation(s) within 1 month prior to start of the investigation.
* Previously randomised to this investigation.
* Life expectance of the subject less than 3 months
* Pregnant or breast-feeding women
Safety Evaluation of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Stroke

A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the ReWalk ReStore device in subjects with hemiplegia/hemiparesis due to ischemic or hemorrhagic stroke.


Eligibility Criteria:
Inclusion Criteria:

* History of one-sided ischemic or hemorrhagic stroke (\>2 weeks post stroke)
* Presentation of hemiparesis/hemiplegia resulting from stroke
* At least 18 years of age
* Height of 4'8" - 6'7"
* Weight of less than 264 lbs
* Medical clearance by a clinician treating the subject
* Able to ambulate at least 5 feet without an ankle foot orthosis (AFO), with no more than minimal contact assistance from a PT
* Able to follow a 3-step command
* Able to fit suit components (waistbelt, calf wrap)
* No greater than 5 degrees of plantar flexion contracture during passive ankle ROM
* Modified Ashworth Scale for spasticity at 3 or less for ankle dorsi-flexors and plantar-flexors

Exclusion Criteria:

* Severe aphasia limiting ability to express needs or discomfort verbally or non-verbally
* Serious co-morbidities that, in the opinion of the investigator, may interfere with ability to participate
* History of significant Peripheral Artery Disease
* Colostomy bag
* Current pregnancy
* Uncontrolled or untreated hypertension
* Currently participating in any other ongoing clinical trial
* Presence of open wounds or broken skin at device locations requiring medical management
* Known urethane allergies
* Current medical diagnosis of DVT
Total Knee Arthroplasty Outcome Study

The purpose of this study is to gather information about total knee replacement surgery using minimally invasive surgical procedures.

The purpose of this study is to gather information about total knee replacement surgery using minimally invasive surgical procedures. The MIS™ Minimally Invasive Solutions™ Total Knee Arthroplasty System has been cleared for use by the Food and Drug Administration.

You are invited to participate in this data collection study, comparing the MIS system to standard knee replacement systems. The decision about which system and operation will be best for you has already been made by you and your orthopaedic surgeon.

The information will be used to compare minimally invasive surgery and the standard surgery procedures. The results of this study will provide information that will add to the knowledge base of knee replacement surgery.

Eligibility Criteria:
Inclusion Criteria:

* Presence of a severely disabled joint secondary to painful osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis that warrants primary knee arthroplasty.
* Gender - Males and females will be included. The male-to-female ratio will depend upon the patient population at each institution conducting the study.
* Age - Minimum of 18 years-old.
* Stable Health - The patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history.
* Patient or patient's legal representative has read and signed the Letter to the Patient form.

Exclusion Criteria:

* Patient is skeletally immature.
* Previous ipsilateral knee arthroplasty.
* Previous Patellectomy.
* Patient is pregnant or breastfeeding.
* Presence of clinically significant disease of the cardiovascular, renal, hepatic, hematologic, respiratory, endocrine, neurological, gastrointestinal, genitourinary, immune systems or other medical condition which is not well controlled.
* Patients who have received an investigational drug or device within the last 30 days.
* Patient is unwilling or unable to cooperate in a follow-up program.
Respiratory Mechanics Registry for ARDS Patients

This registry was proposed to investigate the epidemiology of respiratory mechanics in patients with ARDS through collecting data from a QI project which was constituted with systematic assessments of respiratory mechanics and gas exchange.

The amount of respiratory impairment in patients with Acute Respiratory Distress Syndrome (ARDS) is variable and applying the same ventilator regimen to every patient is questionable. In order to individualize ventilator management, monitoring respiratory mechanics may help to decide ventilator settings or set limits. A systematic assessment of respiratory mechanics and gas exchange response in patients who meet the criteria for ARDS has been initiated as a Quality Improvement (QI) project in the Department of Critical Care at St. Michael's Hospital. The QI project aims to facilitate the use of these parameters for ventilatory management. Measurements include: respiratory system, lung and chest wall mechanics (elastance and resistance), oxygenation response to positive end-expiratory pressure (PEEP), and estimate of alveolar recruitability using a simplified bedside maneuver\[1\]. Placement of an esophageal catheter is considered when the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) ≤200 mmHg\[2\]. Audits are performed to see whether the measurements influence ventilatory management. Collecting these data into a registry will elicit helpful epidemiological information since the current epidemiological knowledge surrounding respiratory mechanics abnormalities in ARDS is limited. A registry with a large sample size may inform future recommendations. The investigators therefore propose to introduce the collected data from our QI program into an ARDS registry. Similar data obtained from other centers may also contribute to the registry in the future. The primary objective of the registry will be to investigate the epidemiology of abnormal respiratory mechanics in patients with ARDS.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the Medical-Surgical ICU, Trauma-Neuro ICU, and Cardiovascular ICU who meet the Berlin definition of ARDS and receive invasive ventilation.

Exclusion Criteria:

* Severe hemodynamic instability: \> 30% variation of mean arterial pressure and/or heart rate (HR) in the last 2 hours or the need for a high dose of vasopressors (higher than 0.5 µg/kg/min of norepinephrine);
* Patients who present with a known esophageal problem, active upper gastrointestinal bleeding, or any other contraindication for the insertion of a gastric tube.
Safety and Efficacy Study of Several Replagal Dosing Regimens on Cardiac Function in Adults With Fabry Disease

The purpose of this study is to compare the safety and effectiveness of various doses of Replagal in patients with cardiomyopathy due to Fabry disease.

Fabry disease is an inherited, metabolic disease caused by mutations in the GALA gene. Patients with Fabry disease accumulate a complex glycosphingolipid named globotriaosylceramide (Gb3) in various tissues and organs. All organs are affected in Fabry disease but the majority of the morbidity and mortality are caused by cardiac, renal and neurological dysfunction. Accumulation of Gb3 in the heart causes hypertrophic cardiomyopathy, valvular abnormalities, arrhythmias and infarctions. Replagal has been shown to reduce Gb3 from key tissues and organs, and stabilize renal function in patients with Fabry disease. Evidence suggests that Replagal reduces left ventricular mass (LVM) and improves midwall fractional shortening (MFS) of the heart. Left ventricular hypertrophy is a major cause of morbidity and mortality in patients with Fabry disease.

This is a study of the safety and effectiveness of 3 dosing regimens of Replagal in adult patients with left ventricular hypertrophy due to Fabry disease.

The primary objective of the study is to compare the effects of 2 dosing regimens of Replagal (0.2 mg/kg IV every other week and 0.2 mg/kg IV weekly) on the reduction of left ventricular mass as measured by echocardiography.

The secondary objectives of this study are to compare the effects of 2 dosing regimens of Replagal (0.2 mg/kg IV every other week and 0.2 mg/kg IV weekly) on each of the following: exercise tolerance; improvement in disease-specific quality of life in heart failure patients; improvement of heart failure symptoms; magnitude of reduction in Gb3; rate of decline in renal function and improvement in the severity of proteinuria/albuminuria; and safety.

An alternative treatment regimen of 0.4 mg/kg Replagal IV weekly will also be explored but without formal comparison to the 0.2 mg/kg regimens. The investigation of the safety and efficacy of the 0.4 mg/kg IV weekly regimen is a secondary objective of this study.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years-old;
* Male:Fabry disease confirmed by deficiency of alfa galactosidase A activity OR Female:Fabry disease confirmed by a mutation of the alfa galactosidase A gene;
* ERT-naïve;
* LVM/h \> 50g/m2.7 for males and \>47 g/m2.7 for females;
* Negative pregnancy test at enrollment and contraception use required throughout study for female patients;
* Signed informed consent;

Exclusion Criteria:

* Class IV heart failure;
* Clinically significant hypertension;
* Hemodynamically significant valvular stenosis or regurgitation;
* Morbid obesity;
* Known autosomal dominant sarcoplasmic contractile protein gene mutation;
* Treatment with any investigational drug or device within the 30 days;
* Unable to comply with the protocol as determined by the Investigator;
* Positive for hepatitis B, hepatitis C or HIV
A Pilot Investigational Study: Treatment of Anxiety With Non-Needle Electro-Acupuncture

The purpose of this study is to determine the effects of non-needle electro-acupuncture on mild to moderate anxiety. The hypothesis is that this style of treatment will reduce state anxiety and not trait anxiety as measured by the Spielberger STAI test.

Persistent and unrelenting stress is defined as anxiety. Anxiety disorders are among the most common mental disorders in society. The NIH estimates that nearly 200 million Americans suffer from anxiety. Anxiety disorders are associated with a lower quality of life, functional impairment and disability, and are also associated with co-morbid physical illness.

Acupuncture, one form of complementary and alternative medicine, has been used to treat anxiety. Non-needle acupuncture is one of the safest methods, with none to rare side effects. This method has been studied in China (Han 1986) and America (Ulett 1998) Pre-intervention testing, then three treatments within one week, will be followed by post intervention testing.

Eligibility Criteria:
Inclusion Criteria: Normally healthy persons with mild to moderate anxiety -

Exclusion Criteria: Severe anxiety, depression, pregnancy, and previous experience with HANS non-needle electro-acupuncture treatment

-
Risk Factors of Bleeding Under Veno Arterial Membrane Oxygenation

Veno arterial extracorporeal membrane oxygenation (VA ECMO) is used, for cardiogenic shock, refractory cardiac arrest and post cardiotomy cardiac failure. Bleeding is frequent complications during VA ECMO and is associated with increased mortality. The aim of our study was to identify early factors associated with major bleeding in patients supported by VA ECMO


Eligibility Criteria:
Inclusion Criteria: Patients over 18 years treated by peripheral veno arterial membrane oxygenation

Exclusion Criteria: None
Effect of Dexamethasone on Post-spinal Hypotension

The goal of this clinical trial is to learn if intravenous dexamethasone is effective for prevention of post spinal hypotension in geriatric population undergoing orthopedic surgeries. The main question aim to answer is:

Does intravenous dexamethasone in participants undergoing orthopedic procedures of lower limb under spinal anesthesia prevents post spinal hypotension? Researchers are comparing two groups of participants

* Participants in (Dexamethasone Group) Group D are receiving intravenous dexamethasone 8mg preoperatively
* Participants in (Placebo Group) Group P are receiving placebo preoperatively.


Eligibility Criteria:
Inclusion Criteria:

Patient undergoing orthopedic surgery in spinal anesthesia. ASA ≤ 2.

Exclusion Criteria:

Patients with history of cardiac arrhythmias. Patients with history of acute coronary syndrome. Patient with history of polytrauma. Patients with contraindication to SA (e.g., coagulopathy, thrombocytopenia, allergy to local anesthetic agent) and those on steroids or serotonin related medications (e.g., selective serotonin reuptake inhibitor) will be excluded.
Intervention to Reduce Sugar-Sweetened Beverage (SSB) Consumption in Children and Families

Pilot randomized trial of a technology-based intervention to reduce sugary drink consumption and promote water intake in families with young children.

This is a pilot 2-arm randomized trial among 60 families of 1-8 year old children who currently over-consume sugary drinks. The study team will randomize families to either an intervention group, that will receive a behavioral intervention consisting of an educational video, water promotion toolkit, mobile phone app, and series of educational phone calls, or to a control group that will not receive this intervention. The study team will compare 6-month change in child and parental beverage consumption between groups. Exploratory analyses will examine child weight (kg) and Body Mass Index (BMI) z-score (BMIz) outcomes, and compare intervention effects across race/ethnic groups.

Eligibility Criteria:
Inclusion Criteria:

* Child 1-8 years old who receives health care attention at Wake Forest pediatric or family medicine practices
* Child consumes 2 or more SSB and/or fruit juice total per day
* Child with no chronic health condition
* Child has not seen nutritionist or visited our family-based weight management clinic in the past year
* parent/caregiver who has not watch educational video "Get in the Zero Zone"
* parent/caregiver has a smartphone and reliable internet
* parent/caregiver able to communicate well in English

Exclusion Criteria:

* Child doesn't meet age criteria
* Child consumes less than 2 SSB and/or fruit juice total per day
* Child with a chronic health condition
* Child has seen nutritionist or visited our family-based weight management clinic in the past year
* parent/caregiver has watched educational video "Get in the Zero Zone"
* parent/caregiver has completed interview or usability test
* parent/caregiver doesn't have a smartphone or reliable internet
* parent/caregiver not able to communicate well in English
Clinical Characteristics, Treatments, and Outcomes of MI Patients Presenting With Normal ECG

the investigators aimed to analyzed data for hospitalized MI patients with normal ECG.

The electrocardiogram (ECG) at presentation is a useful tool for risk prediction. Patients with ACS（Acute Coronary Syndromes） and ST-segment depression on ECG have a worse prognosis than patients with a normal ECG. ST-segment depression is not only a qualitative marker, but also a quantitative marker of risk, because the number of leads with ST-segment depression and the magnitude of ST-segment depression (either within a single lead or as sum over all leads) are indicative of the extent of ischaemia and correlate with prognosis.The presence of ST-segment depression \>1 mm in \>_6 leads in conjunction with ST-segment elevation in aVR and/or V1, particularly if the patient presents with haemodynamic compromise, suggests multivessel ischaemia or severe left main coronary artery stenosis. However,in patients presenting without persistent ST-segment elevation,the clinical features, treatments, and outcomes in patients with normal ECG is still unclear.

Eligibility Criteria:
Inclusion Criteria:all patients hospitalized with a principal diagnosis of non-ST-segment elevation infarction (NSTEMI) according to the current ACC/AHA guidelines.

exclusion criteria: end-stage organic disease, thrombotic hematological disorders, and poor echogenicity
Review of the Literature and Serie of Patients Who Underwent Reconstruction After Wide Local Excision of Nail Apparatus for Melanoma

Melanomas of the nail bed are often diagnosed at the locally advanced stage. The standard treatment was amputation of the finger or toe, but it has now been established that enlarged excision of the nail plate is sufficient under certain conditions. Reconstruction of the nail system can be performed by several techniques. Here, the investigators present a series of patients reconstructed by INTEGRA (dermal matrix) and skin graft


Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone enlarged resection of the nail apparatus with immediate or delayed reconstruction in the setting of acral melanoma of the fingers or toes.

Exclusion Criteria:

* Patients who have amputation, opposition of the pateint to the study.
EPO906 Therapy in Patients With Advanced Kidney Cancer

This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause kidney cancer.


Eligibility Criteria:
Inclusion Criteria:

The following patients may be eligible for this study:

* Histologically or cytologically documented evidence of epithelial renal cell carcinoma with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
* Patients must have had a prior nephrectomy
* Must have a life expectancy of greater than three (3) months
* Patients who have had 0-1 prior cytokine treatment regimen (i.e. IL-2, IFN-?) or relapsed less than one year after such treatment may be eligible.

Exclusion Criteria:

The following patients are not eligible for this study:

* Patients who have received more than one (1) prior cytokine regimen (i.e. IL-2, IFN?) or relapsed more than one year after receiving such treatment are not eligible
* Patients who have had any prior chemotherapy (including a combination therapy)
* Patients with symptomatic CNS metastases or leptomeningeal involvement
* Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
* Patients with severe cardiac insufficiency
* Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
* History of another malignancy within 3 years prior to study entry except curatively treated non-melanoma skin cancer, prostate cancer, or cervical cancer in situ
* Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
* HIV+ patients
* Pregnant or lactating females.