cyrilzakka/clinical-trials huggingface dataset:
A Study To Establish The Equivalence Of 2 Palbociclib (PD-0332991) Formulations To The Intended Final Market Product

This study is intended to establish the equivalence of 2 formulations to the intended final market product. The formulations to compare are the capsule given to patients in the phase I and II studies and the capsule that is being administered to the patients in the phase III trials. Both capsules will be compared to the intended final market capsule. The comparison will be performed looking at the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing these parameters calculated after a single 125 mg dose of the 3 capsules identifying like that if there are significant differences between these 3 formulations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Any condition possibly affecting drug absorption
IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study

IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of necrotizing enterocolitis.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age at birth of 23 weeks+0 days to 32 weeks+0 days
* Birth weight 500-1500g
* ≤ 48 hours of age
* Written informed consent from the subject´s legally authorized representative (LAR)

Exclusion Criteria:

* Participation in any other interventional clinical trial
* Infants in extremis to whom no further intensive care is offered by attending neonatologist
* Infants with, or at a high probability for, early onset sepsis
* Infants with recognized chromosomal anomalies
* Congenital or acquired gastrointestinal disease
* Earlier or planned administration of formulas, foods or supplements that contain added live bacteria
* Infants with known positive maternal HIV status
A Comparative Study of Papacarie® and the Conventional Method for Dental Caries Treatment

The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison to the conventional drilling method.

Dental caries in children continues to affect a significant portion of the world population, especially in developing countries. There are many techniques used for dental caries treatment. The conventional method is to remove caries and prepare the cavity using dental burs. Disadvantages of this method; however, include the patients' repulsion of drilling, and possible thermal changes on tooth surface that may have an effect on the dental pulp tissues. In addition, the drilling technique frequently requires local anesthesia injections and sometimes results in the removal of sound tooth tissues. To overcome these problems and preserve the healthy dental tissues, the chemo-mechanical caries removal method was developed. The advantage by chemomechanical caries removal include less traumatic, less need local anesthesia, reduced chance of dental pulp exposure. And also it could be benefit to medical compromised patients.

Papacarie® is a new chemo-mechanical technique for caries removal with few published research and case reports. A randomized controlled trial is therefore needed to determine the efficacy of its use in general population. The aims of this study are to evaluate the efficacy of a chemo-mechanical system (Papacarie®) for caries removal in comparison to the conventional drilling method.

Eligibility Criteria:
Inclusion Criteria:

* Patient inclusion criteria:
* Child is between 7-8 years of ages (at date of enrollment) with at least one active caries lesion in second primary molar tooth with distinct dentine involvement requiring restoration
* Child is in good general health and has no existing health condition that may interfere with treatment such as asthma, tuberculosis, rheumatic fever/ congenital heart diseases, jaundice, juvenile diabetes, haemophilia, thalassemia, leukemia, anemia , HIV , allergy to any drug, and epilepsy.
* Tooth inclusion criteria:
* Second primary molar tooth with one active caries lesion with distinct dentine involvement requiring restoration using the World Health Organization Criteria.
* Tooth with isolated occlusal caries and caries extended on further than two-third of the dentine layer, which can be restoration as a Class I restoration.
* Carious cavity must be large enough so that the hand instruments can be operated.
* Tooth is vital without pathological process assessed clinically and radiographically.

Exclusion Criteria:

* Patient exclusion criteria:
* Child whose parent does not give informed consent.
* Child who are unwilling to undergo the dental treatment.
* Child who has a known allergy to the ingredients contained in dental anesthesia, Papacarie® or glass-ionomer filling material.
* Tooth exclusion criteria:
* Having extensive dental caries which may require pulp treatment.
* Tooth with a pathological process of the dental tissue other than caries that could affect the treatment, such as tooth development disorders or adjacent soft tissue lesion.
A Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent

The purpose of this study is to assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma (POAG)
* Subjects on two topical hypotensive medications

Exclusion Criteria:

* Traumatic, uveitic, neovascular, or angle closure glaucoma
* Fellow eye already enrolled
The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer

The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and compare its performance with the standard of care, saline moistened gauze, for the treatment of diabetic foot ulcers.


Eligibility Criteria:
Inclusion Criteria:

1. A full thickness diabetic foot ulcer with a viable wound bed free of necrotic material (grade 1 on Wagner scale).
2. Diagnosis of diabetes mellitus (type I or II) adequately controlled.
3. The ulcer is greater than 4 weeks duration.
4. Three or fewer ulcers separated by \> 3.0 cm distance.
5. Post-debridement, the ulcer size must be between 1 and 10 sq cm2.
6. Ankle/brachial index is between 0.7 to 1.2 and or one of the following must be present:

   * transcutaneous partial pressure oxygen (TcPO2) \> 30 mmHg at the ankle
   * toe pressure of \>40mm Hg or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)
7. At least 18 years old.
8. Able and willing to provide a voluntary written informed consent.
9. Able and willing to wear an off-loading orthopedic shoe.
10. Able and willing to attend scheduled follow-up visits and study related exams.

Exclusion Criteria:

1. Greater than 30% reduction in wound size during first week of observation by the investigator.
2. Ulcer with exposed tendon or bone.
3. Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis.
4. Gangrene.
5. Active Charcot's disease as determined by clinical and radiographic examination.
6. Ulcer of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers).
7. Known severe anemia.
8. Known serum albumin \< 2.5.
9. Renal failure with Creatinine \> 2.5.
10. Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV.
11. Severe liver disease as defined by the treating physician or patient's primary care physician.
12. Malignancy at or near the ulcer site.
13. Any condition judged by the investigator that would cause the study to be detrimental to the patient.
14. Presence of a hematology, clinical, chemistry or other test obtained within 7 days of screening that is outside the normal range for the laboratory and is determined to be clinically significant by the investigator.
15. Received another investigational device or drug within 30 days of Day 0.
16. Radiation therapy, chemotherapy or immunosuppressive therapy within 30 days of enrollment.
17. Received another allograft, autograft or xenograft within 30 days of the Day 0.
18. Known allergy to equine derived tissue.
19. Alcohol or drug abuse, defined as current medical treatment for substance abuse.
20. Pregnant or nursing women.
Soluble Dietary Fibres in the Prevention of Type 2 Diabetes Mellitus

Controlling the glycemic impact of foodstuffs (by reducing the glycemic load of the diet by using soluble dietary fibres) may reduce the glycemic or insulinemic response. This may in turn result in a reduced inhibition of postprandial fat oxidation rate and a lower plasma triacylglycerol concentration A higher postprandial fat oxidation may result in less lipid accumulation in non-adipose tissue thereby improving insulin sensitivity and the metabolic profile in the longer term.


Eligibility Criteria:
Inclusion Criteria:

* Overweight men and women

Exclusion Criteria:

* regular smokers, athletes, diabetes mellitus
Approach to Ankle Sprains in the Emergency Department

The aim of this study is to evaluate the short-term effects of routinely applied agents on pain and joint range of motion (ROM) in ankle sprains presenting to the emergency department (ED).

It is aimed to examine the effects of intravenous (IV) 50 mg dexketoprofen, IV ibuprofen 400mg and IV paracetamol 10 mg on pain and joint range of motion. To determine the effects of these agents on pain, the easily applicable Numerical Rating Scale (NRS) and Wong-Baker Faces Pain Rating Scale will be used. A standard handheld half-circle goniometer will be utilized to calculate active ankle joint ROM.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older who present to the emergency department within the first 72 hours after ankle sprain.
* Grade 1 (mild) and Grade 2 (moderate) ankle sprains.
* Exclusion of fractures and dislocations (after X-ray according to Ottawa rules).
* Absence of muscle-tendon ruptures.
* Absence of vascular and nerve injuries.
* Absence of open wounds and burns.
* Stable vital signs.
* Patients who provide written and verbal consent.

Exclusion Criteria:

* Patients who did not present to the emergency department within the first 72 hours after ankle sprain.
* Grade 3 (severe) ankle sprains.
* Multiple traumas.
* Pregnancy or suspected pregnancy.
* Ankle fractures and dislocations.
* Forensic cases.
* History of previous ankle surgery or fracture.
Primary Care Group Therapy for Depression/Anxiety for Women in Petropolis

This is a randomized controlled trial comparing two groups: 1) Enhanced usual care and 2) Enhanced usual care plus group psychological intervention. In both groups a "stepped care" approach was used to the management of anxiety and depression among women seen in primary care.

All patients received enhanced primary care, which included: (1) The nurses and doctors from the Family Health Teams were trained by Matrix team mental health professionals on clinical aspects of depression and anxiety, including diagnosis, appropriate medication interventions, psycho-education, and cognitive and problem solving therapy. (2) Given the high co-occurrence of anxiety and depression, the intervention was modified from the depression-only Chile model to emphasize co-occurring anxiety and depression in diagnoses, appropriate prescription of anxiolytics and antidepressants. (3) All providers received weekly group or individual consultation with a Matrix team mental health professional, either psychiatrist or psychologist. An qualitative study of participating Petrópolis Family Health Programme doctors and nurses demonstrated their satisfaction with the training.

Patients in the intervention arm received enhanced primary care plus a 9-session group intervention (seven sessions weekly then two sessions every 15 days). The intervention included two psycho-educational sessions with information about depression and anxiety disorders, two sessions on the development of pleasant activities including relaxation exercises, two sessions on solving problems therapy, one session on the problem of overcoming negative thoughts and emotions, one session on relapse prevention, and a final closure and review session which included a small party. The patients from the intervention arm also received additional outreach from the Family Health Teams, including home delivery of psychotropic medication when needed and active outreach and engagement by community workers if patients missed group sessions.

Eligibility Criteria:
Inclusion Criteria:

* female patients who came to the primary care unit for any type of consultation for themselves (e.g., not for a child).
* General Health Questionnaire positive screen (\>5 at two time points)
* positive diagnosis of depression or anxiety per the Mini Mental State Examination.

Exclusion Criteria:

* diagnosis of bipolar disorder, mania, severe suicidal ideation
* cognitive impairment that would limit their ability to consent or take part in the study. -pregnant.
Observational Study on the Outcome of AML Patients Treated With New Drugs in Real-life (BoxTrial)

This multicenter, prospective and retrospective observational study aims to evaluate the use and efficacy of new drugs or their combinations in real-life in a population of adult AML patients.

This multicenter, prospective and retrospective observational study (model: case only) aims to evaluate the use and efficacy of new drugs or their combinations in real-life in a population of adult AML patients treated at Italian GIMEMA centers. No additional procedures or visits other than those required by normal clinical practice will be required. every patient will be followed for a minimum of 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older
2. AML diagnosis according to the ELN guidelines, excluding M3
3. Signed Informed consent, if applicable
4. Treatment initiation with novel drugs in monotherapy or combination, in accordance with the AIFA authorizations, from the AIFA registration up to 31.12.2027 with particular attention to:

   * patients affected by FLT3-mutated AML treated with gilteritinib.
   * patients affected by IDH-mutated AML treated with IDH inhibitors.
   * patients affected by AML in maintenance therapy with oral azacytidine.
   * patients affected by AML treated with glasdegib.
   * patients affected by AML treated with gemtuzumab ozogamicin.
   * other novel drugs or combination for the treatment of AML approved during the study period.

Exclusion Criteria:

Patients included in interventional clinical trials.
Incheon-Bucheon Cohort of Patients Undergoing Primary PCI for Acute STEMI

INcheon-Bucheon cohorT of patients undERgoing primary percutaneous coronary intervention for acute ST-ELevation myocardiaL infARction (INTERSTELLAR) registry is a retrospective, observational, 4-regional-hospital based registry reflecting current practices of management, risk factors, and clinical outcomes in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention at cities of Incheon and Bucheon located in the mid-western part of the Korean peninsula between 2007 and 2014.

INcheon-Bucheon cohorT of patients undERgoing primary percutaneous coronary intervention for acute ST-ELevation myocardiaL infARction (INTERSTELLAR) registry is a retrospective, observational, 4-regional-hospital based registry reflecting current practices of management, risk factors, and clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) at cities of Incheon and Bucheon located in the mid-western part of the Korean peninsula between 2007 and 2014. Diagnosis of acute STEMI was based on clinical data findings including typical symptoms, 12-lead electrocardiography, and blood test. Decisions regarding primary PCI were made by at least 2 attending cardiologists at the time of presentation.

Demographic data, cardiovascular risk factors, laboratory data and clinical follow-up data were collected. Baseline blood test was obtained and recorded as part of the routine care for patients who visited the emergency room for chest pain and in whom acute coronary syndrome was suspected. Standard medical management was provided by responsible physicians.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with acute ST-segment elevation myocardial infarction
* Patients treated with primary percutaneous coronary intervention

Exclusion Criteria:

* Patients diagnosed with Non-ST-segment elevation acute coronary syndrome
* Patients treated with thrombolytic therapy
Remote Patient Monitoring and Detection of Possible Diseases With Artificial Intelligence Telemedicine System

Remote patient monitoring and detection of possible diseases with Artificial Intelligence Telemedicine System

Possible disease detection with artificial intelligence from the patient's vital values possible disease detection from the patient's examination records

Eligibility Criteria:
Inclusion Criteria:

* No Eligibility Criteria

Exclusion Criteria:

-
Respiratory Drive in Patients With Univentricular Congenital Heart Disease

The aim is to evaluate the correlation between the respiratory control to hypercapnia at rest and the VE/VCO2 slope measured during cardiopulmonary exercise testing.

The hypothesis is that patient with univentricular congenital heart disease have a increasing of respiratory drive like chronic heart failure. This increasing of respiratory drive could participate in the increasing of VE/VCO2 slope measured during cardiopulmonary exercise testing and in the genese of central apnea index during the sleep.

The patients with univentricular congenital heart disease will perform :

* a cardiopulmonary exercise testing with measure VE/VCO2 slope,
* a measure of the respiratory drive to hypercapnia with occlusion pressure during the rebreathing with at rest (P0,1/PetCO2).
* A polysomnography with a scoring of central apnea index. Correlation will be evaluate between P 0,1/PetCO2 with VE/VCO2 slope and between P0,1/PetCO2 central apnea index.

Eligibility Criteria:
Inclusion Criteria:

* Functionally univentricular congenital heart disease
* Age ≥ 8 years
* Consent of the adult patient or the parents or legal guardians of the minor patient.
* Beneficiary of the social security scheme

Exclusion Criteria:

* Size \<120 cm (minimum size for the stress test)
* Medical contraindication to exercise test or presence of : myocardial infarction less than 3 months old, unstable angina, uncontrolled severe arrhythmias, symptomatic aortic stenosis, uncontrolled heart failure, pulmonary embolism, evolutionary phlebitis, pericarditis, myocarditis, progressive endocarditis, aortic dissection
* Unstable patient with severe intellectual disability or complex pathology making polysomnography impossible
* Pregnant woman
Follicle Stimulating Hormone (FSH) Receptor Polymorphisms in In-Vitro Fertilization Cycles.

This study is being done to identify if certain sequences (patterns) of key genes (called polymorphisms) may predict a response to fertility medications. The investigators will also determine if the individual response to fertility medications affects pregnancy rates in in-vitro fertilization.

All IVF patients who meet inclusion criteria and not exclusion criteria will be asked to participate in this study. Upon consent, a blood sample will be obtained in 2 EDTA containing lavender topped tubes before, during or within 3 months after their IVF cycle. Genomic DNA will be extracted and saved for genotyping.

The Investigators will collect data on each individual's age, ethnic background, and estradiol levels on the day of hCG administration, total gonadotropin amount, clinical pregnancy rates, basal FSH levels, and occurrence of OHSS. The Investigators will then analyze all samples from all patients for their FSH receptor genotypes.

Patients will be compensated $75 via a check within 6-8 weeks of their blood drawn.

Eligibility Criteria:
Inclusion Criteria:

1. 100 women less than 35 years old at time of signing the Informed Consent Form.
2. Day 3 FSH level less than or equal to 10 mIU/ml with an estradiol \< 70 pg/ml
3. Day 3 antral follicle count of greater than 10 follicles total.
4. Couples who have male factor infertility, tubal factor infertility, and unexplained infertility.

Exclusion Criteria patients who have:

1. Endometriosis
2. Polycystic ovarian syndrome
Post-discharge Monitoring of Patients With Heart Failure

What is proposed in this project is to develop and evaluate the effectiveness of an online remote monitoring system that is easily accessible to patients so that professionals with experience in monitoring patients with heart failure (HF) can monitor signs and symptoms of decompensation of the disease, as well as self-care actions. A randomized, blind trial for outcome evaluation was designed that will include patients hospitalized for acute HF at a referral institution in cardiology in southern Brazil. Patients in the intervention group will be followed up with a remote monitoring system, accessible by device (computer, tablet and cell phone) connected to the internet, by checking for signs, symptoms and self-care actions in three moments during 30 days after hospital discharge. Patients in the control group will follow up according to the routine of the hospital or physician assistant. The primary endpoint for assessing the efficacy of the system will be hospital readmission within 30 days (follow-up period). The information regarding the signs, symptoms and self-care of the patients will be monitored by the research team through an access schedule. The sample calculation points to the need to include a total of 142 patients (71 in each group). The data will be analyzed through descriptive and analytical statistics. It is hoped that the development of a remote monitoring system could be characterized as a strategy for the early detection of signs and symptoms of acute decompensation in HF patients, impacting on hospital readmission rates within 30 days after discharge. In addition, remote monitoring of signs and symptoms may promote improved adherence and self-care of patients. The scientific contribution will occur to the extent to which there is innovation in patient follow-up and feedback obtained from the patient's interaction with the system.


Eligibility Criteria:
Inclusion Criteria:

* with diagnosis of HF or hospitalized for acute HF

Exclusion Criteria:

* degenerative neurological diseases;
* patients with renal / hepatic / pulmonary or systemic disease that may confuse the interpretation of findings or result in limited life expectancy;
* surgical or therapeutic plan that may influence the follow-up;
* pregnancy;
* diagnosis of acute HF secondary to: sepsis, myocarditis, acute myocardial infarction, peripartum and other acute cause;
* not be able to contact by phone.