cyrilzakka/clinical-trials huggingface dataset:
Reversibility of Dual Antiplatelet Therapy by Platelets

The objective of the study is to test the hypothesis whether or not autologous stored platelets are able to offset the antiplatelet effect of aspirin and clopidogrel as assessed by state-of-the-art platelet function assays.

Dual antiplatelet therapy with aspirin and clopidogrel is a well established strategy to prevent thrombotic complications in patients with high platelet reactivity following plaque rupture in acute coronary syndromes (ACS) or percutaneous coronary interventions. Current practice guidelines for antiplatelet therapy advocate a one to 12 months dual antiplatelet therapy after bare metal stent PCI and a 12 months dual antiplatelet therapy after PCI in patients with ACS and drug eluting stent PCI. Although oral antiplatelet therapy is associated with both, short- as well as long-term clinical efficacy, irreversible platelet inhibition carries a substantial risk of bleeding particularly in patients presenting for surgery. Empiric therapy of bleeding consists of platelet transfusion. However, there are currently no pharmacodynamic studies assessing the effect of stored platelets on in-vitro platelet function tests.

Healthy volunteers will donate platelets, take aspirin and clopidogrel for 3 days (loading dose aspirin 300 mg, clopidogrel 300 mg, maintenance dose aspirin 100 mg, clopidogrel 75 mg) and platelets will be retransfused on the 4th day. Pharmacodynamic measurements of platelet function will be performed at baseline, after drug intake before retransfusion, immediately after retransfusion and 24 hours thereafter.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent
2. Healthy volunteers, male or female (after exclusion of pregnancy if they are on birth control pill or have a contraceptive coil implanted)
3. Age of consent
4. Weight: 70 kg - 100 kg
5. Platelet count 240 000 to 440 000/µL
6. Hematocrit \> 40%
7. readiness to refrain from any activities prone to injury during the study period.

Exclusion criteria:

1. Allergy against aspirin or clopidogrel
2. History of bleeding
3. History of peptic ulcer
4. Intake of aspirin or NSAR during the last ten days before screening
5. Gastrointestinal disease precluding resorption of aspirin and clopidogrel
6. Scheduled surgery
7. Any current medication
8. History of hepatic disease
9. 20µm ADP induced aggregation \< 60% at screening
10. CYP2C19 polymorphisms
11. Donation of blood within the preceding 4 weeks
12. Neurotic disease
13. Current smoking
14. Drug addiction
15. Intake of grapefruits during the last 10 days before
An All-Oral Combination of Capecitabine and Cyclophosphamide in Patients With Metastatic Breast Cancer (MBC)

The primary objective of this study is to evaluate the time to progression. Secondary objectives are safety, OS and pharmacogenetic analysis. Sixty patients will be enrolled into this study.

Xeloda (capecitabine) is converted to 5-fluorouracil by thymidine phosphorylase, and cyclophosphamide is capable of upregulating the expression of thymidine phosphorylase suggesting a synergistic effect.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed breast cancer
* Anthracycline and taxane pretreated metastatic breast cancer
* Have not been previously treated with capecitabine
* ECOG performance status of ≤ 1
* Are female and ≥ 18 and ≤ 70 years of age
* Have at least one target lesion according to the RECIST criteria

Exclusion Criteria:

* Pregnant or lactating women
* ECOG ≥ 2
* Have been treated with capecitabine
* Evidence of CNS metastasis
* History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer
* Abnormal laboratory values: hemoglobin \< 8.0 g/dl, neutrophils \< 1.5×10\^9/L, platelets \< 100×10\^9/L, serum creatinine \> upper limit of normal (ULN), serum bilirubin \> ULN, ALT and AST \> 5×ULN, AKP \> 5×ULN
* Serious uncontrolled intercurrent infection
* Life expectancy of less than 3 months
Study to Understand Usage and Effect of Saxagliptin as First Add-On After Metformin in Indian Type 2 Diabetes Mellitus Patients

This is a multicentre, non-interventional, prospective, observational study which would be conducted in India to understand the usage and effect of saxagliptin as first add-on therapy after metformin. The study will enroll Type 2 Diabetes Mellitus (T2DM) patients who were inadequately controlled with metformin alone and have been recently prescribed saxagliptin as an add-on to metformin.

This is a multicentre, non-interventional, prospective, observational study which would be conducted in India to understand the usage and effect of saxagliptin as first add-on therapy after metformin. The study will enroll Type 2 Diabetes Mellitus (T2DM) patients who were inadequately controlled with metformin alone and have been recently (i.e. within past 15 days) prescribed saxagliptin as an add-on to metformin.

The Investigator/designee would get signed informed consent from potential subjects of the study. The patients who meet all inclusion and none of the exclusion criteria will be enrolled in the study. These patients will then be assigned a patient identification number for the study. The Investigator/designee will collect the information as per the study schedule. This will be considered as Visit 1 of the patients. The patients will be managed as per the routine clinical practice of the physician for their condition and this study will neither interfere/advise the Investigators/designee for any drug/medication to be prescribed to the patients nor prescribe any intervention to them.The enrolled patients would then be asked to visit their respective study sites after 3 months ( +7 days) for the Visit-2 of study.

Around 50 study centers throughout India will be selected with a goal of enrolling up to 1500 patients (approximately 30 subjects each per site). The study will be initiated after obtaining written approval of Independent/Institutional Ethics Committee and written Informed consent of the patient.

Eligibility Criteria:
Inclusion Criteria:

1. Patients willing to provide informed consent.
2. Female or male patients aged 18 years or above.
3. Patients with known case of Type 2 diabetes mellitus.
4. Patients with inadequate glycaemic control taking metformin monotherapy (minimum dose of 500 mg OD) for at least 3 months.
5. Patients who have recently (last 15 days) been prescribed saxagliptin in addition to metformin.

Exclusion Criteria:

1. Patients with Type 1 diabetes mellitus.
2. Patients taking glucose lowering drugs apart from metformin or saxagliptin.
3. Any medical condition of the patient which in the opinion of Investigator would interfere with safe completion of the study.
4. Pregnant or lactating women.
5. Women of childbearing potential not ready to use an effective barrier contraceptive method during the study.
Child-Adult Relationship Enhancement in Primary Care (PriCARE) / Criando Niños Con CARIÑO (CARIÑO)

The purpose of this study is evaluate the effectiveness of PriCARE/CARIÑO to reduce child maltreatment, improve parent-child interactions, and reduce harsh/neglectful parenting, parent stress, and child behaviors.

The primary objective of this study is to evaluate the effectiveness of PriCARE/CARIÑO to reduce investigations of suspected Child Maltreatment (CM) by Child Protective Services (CPS), and CM risk as measured by the Brief Child Abuse Potential Inventory (BCAP).

The secondary objectives of this study are to measure the impact of PriCARE/CARIÑO on:

1. Parent-reported child behavior problems as assessed by the Eyberg Child Behavior Inventory (ECBI).
2. The quality of the parent-child relationship as measured by the Dyadic Parent-Child Interaction Coding System (DPICS).
3. Parenting stress as measured by the Parenting Stress Index-Short From (PSI).
4. Harsh parenting as measured by Conflict Tactics Scales, Parent-Child version (CTS) and the Parenting Scale (PS)

The investigators will perform a randomized controlled trial (RCT) of the effectiveness of the PriCARE/CARIÑO on objectives listed above among 2- to 6-year-old children and their parents at 3 Children's Hospital of Philadelphia (CHOP) Primary Care Centers and 10 pediatric clinics in North Carolina. The investigators intend to randomize 966 child-caregiver dyads (1932 subjects) to receive PriCARE/CARIÑO plus usual care (intervention group) and 966 child-parent dyads (1932 subjects) to receive usual care (control group). CM risk, parenting attitudes and skills, child behavior, and quality of the child-caregiver relationship will be measured at baseline and approximately 6-8 months after randomization for both the intervention and control groups. CPS investigations will be collected starting 4 months after randomization until the end of the study (up to 52 months).

Eligibility Criteria:
Inclusion Criteria:

* Caregiver is age 18 years or older
* Caregiver is English or Spanish Speaking
* Caregiver is legal guardian of child subject
* Caregiver provides informed consent
* Caregiver is available to attend scheduled times of PriCARE/CARIÑO groups
* Caregiver has cellular phone with text messaging capacity
* Caregiver has appropriate technological tools and access to participate in virtual intervention
* Child is between 18 months and 6 years old
* Child receives care at participating primary care center
* Child has Medicaid/Children's Health Insurance Program (CHIP)/no insurance
* Child lives in North Carolina or Philadelphia

Exclusion Criteria:

* Caregiver or another caregiver in the household has previously participated in PriCARE/CARIÑO
* Child has a cognitive functioning below 2-year-old level, as determined by the screening questions and/or the referring clinician
* Child has a diagnosis of autism
* Child is receiving individual behavioral health treatment or medication for a behavioral health problem
Bleeding Time Study With AZD6482, Clopidogrel and ASA

The primary purpose of this study is to evaluate the effect of AZD6482 and clopidogrel on bleeding time when taken together with low-dose ASA.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
* Provision of written informed consent

Exclusion Criteria:

* Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.
* Acute illness, surgical procedure or trauma from 2 weeks before pre-entry visit until the first baseline visit or clinically significant abnormalities in clinical chemistry, haematology, urinalysis or supine BP or pulse
* Known impaired glucose tolerance, known galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or known or suspected Gilbert's syndrome
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.

This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* on dialysis therapy for at least 12 weeks before screening;
* receiving darbepoetin alfa iv for at least 8 weeks before screening.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* administration of another investigational drug within 4 weeks before screening, or during the study period.
Cocaine Opioid Oxytocin Option - Limited

This is a pilot feasibility study assessing the tolerability of chronic administration of intranasal oxytocin to patients receiving methadone at an opioid replacement clinic who are actively using cocaine.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled as a patient in the San Francisco General Hospital Opioid Treatment Outpatient Program
* Stable dose of methadone for at least the past two weeks
* At least one routine urine toxicology screen positive for cocaine in the past month

Exclusion Criteria:

* Positive urine pregnancy test
* Use of illicit drugs in the past month (with the exception of cocaine or cannabis)
* Currently meets Diagnostic and Statistical Manual-5 (DSM-V) criteria for severe major depressive disorder with suicidal thoughts or actions
* History of psychotic or moderate-severe alcohol use disorder as defined by DSM-V criteria
* Severe neuropsychological disorder, brain trauma, epilepsy
* Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol hemihydrate)
* Nasal obstruction, discharge, or bleeding
* Habitually drinks large volumes of water
* Taking testosterone, estrogen/progesterone supplement, or serotonin-1a receptor agonists/antagonists
Induced Hypoxia Study for Validation of SpO2 Accuracy

Validate Non-Motion SpO2 Accuracy from 70%-100% of various pulse oximeter/ sensor combinations and various OEM pulse oximeter modules and sensor combinations during induced hypoxia (desaturation).

The testing is conducted on 12 healthy, consenting, non-smoking subjects in accordance with the IRB approved Protocol. The subjects shall be distributed across both genders and a range of skin tones as equally as practical.

An arterial line will be placed in the radial artery of each subject's right arm, and sensors will be attached to each subject. The subjects will be placed in a semi-supine position and allowed to breathe through a mouthpiece while the nose is blocked with a nose-clip.

Hypoxia will be induced by on each subject, as levels of oxyhemoglobin saturation (between 70% and 100%) are achieved by breathing mixtures of nitrogen, room air and carbon dioxide. Inspired O2 concentration will be adjusted breath-by-breath using a computed saturation, based on end-tidal PO2 and PCO2, as sampled by a mass spectrometer. Predicted levels of oxyhemoglobin saturations will be attained and held stable. At a minimum of sixty seconds into each plateau, a 0.5cc waste blood draw through the arterial line, followed by the first 1.0cc sample blood draw. After approximately thirty additional seconds, the second 1.0cc sample blood draw will be taken. The samples will immediately be analyzed by a Radiometer OSM-3 multi-wavelength co-oximeter and recorded. The SpO2 data from the oximeters will be collected via a laptop computer. Concurrent with the end of each blood draw, a marker will be generated on the laptop computers to identify the event.

Eligibility Criteria:
Inclusion Criteria:

* Non-smokers
* Healthy; no known blood disorders
* Finger sizes within the sensor specifications
* Minimum 18 years of age

Exclusion Criteria:

* Artificial nails or fingernail polish
Normative Data of Brain Network Activation

Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in three age groups.

Currently, there is no reliable, bedside, and non-invasive method for assessing connectivity changes in electrophysiological activity of the brain associated with brain-related pathologies, e.g., concussion, ADHD, autistic spectrum disorders (ASD), etc. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a non-invasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA) to temporally and spatially map brain function, connectivity and synchronization.

The need of objective measures that will help the clinician in its decision making in brain-related pathologies is recognized. BNA is a new imaging modality that has been developed to fill this gap.

Eligibility Criteria:
Inclusion Criteria:

* Age 15-30 years.
* Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments.
* Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).

Exclusion Criteria:

* Currently participate in a contact sport (e.g., football, hockey, soccer, rugby, lacrosse, martial arts).
* Currently with lice or open wounds on scalp.
* Any chronic disease as determined by clinical evaluation and medical history.
* Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc. as determined by clinical evaluation and the Mini International Neuropsychiatric Interview (MINI)
* Any CNS neurologic disorder, e.g., epilepsy, seizures, etc. as determined by clinical evaluation
* History of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder.
* History of any medication affecting CNS within the last 3 months, e.g., antidepressants, anticonvulsants, psychostimulants, first generation antihistamines, etc.
* Substance abuse in the last 3 months.
* Significant sensory deficits, e.g., deafness or blindness.
* History of any clinically significant brain trauma as determined by the investigator
Frequency of Dysphonia in Asthmatic Patients

For many years, it is known that asthmatics have more often dysphonia. However, no study has so far analyzed the reality of dysphonia in asthmatic by making phoniatric tests.

The etiology of dysphonia in asthmatic remains controversial. Indeed, for a long time, inhaled corticosteroids have been considered as responsible for organic abnormalities of the vocal cords. We hypothesized that women with asthma have more often dysphonia, and that dysphonia is rather functional origin.


Eligibility Criteria:
Inclusion Criteria:

* Women
* Aged between 18 to 65 years
* Patient who signed the informed consent.
* affiliated with a social security system.

Patients with asthma (GINA criteria)

- persistent asthma with inhaled corticosteroids.
Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)

Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong participant life and control disease-related symptoms.

In this study, participants with CLL, without prior treatment will receive either venetoclax plus obinutuzumab combination treatment that is considered a standard first line treatment or receive sonrotoclax plus zanubrutinib. It is hypothesized that sonrotoclax plus zanubrutinib may be better than venetoclax plus obinutuzumab in treating CLL.

The main purpose of this study is to compare the duration the participants live without the CLL getting worse between participants who received venetoclax plus obinutuzumab versus sonrotoclax plus zanubrutinib. Approximately 640 participants will be included in this study around the world. Participants will have equal chance to be allocated to receive either of the treatment combinations.

Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment
* Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
* Measurable disease by Computer Tomography/Magnetic Resonance Imaging
* Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin \< 3.0 x ULN
* Adequate renal function as defined as creatinine clearance ≥ 50 milliliters per minute

Exclusion Criteria:

* Previous systemic treatment for CLL
* Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
* Known central nervous system involvement
* History of confirmed progressive multifocal leukoencephalopathy (PML)
* Uncontrolled hypertension

Note: Other protocol defined criteria may apply
China Red Eye Study

This study intends to use a hospital-based multi-center cross-sectional study to understand the disease composition of "red-eye" patients in Chinese ophthalmology clinics. This study will provide important clinical diagnosis and treatment data for common eye diseases in China with "red eye" as the main performance.

Red eye is a common sign of eye diseases. Eye diseases such as ocular surface inflammation, glaucoma, and uveitis can be expressed as red eyes. The disease with red eye as the main complaint is the most common condition that clinicians need to identify. It is not uncommon to be misdiagnosed and missed clinically. The collection and analysis of the disease composition of the "red eye" in Chinese ophthalmology clinics will help to understand the current status of "red eye" related diseases and provide a systematic and comprehensive clinical basis for the differential diagnosis of red eye.

Eligibility Criteria:
Inclusion Criteria:

* Confirmation of signs under the slit lamp is red eye

Exclusion Criteria:

* The investigator believes that there are any unsuitable reasons for participating in the trial.
Custom Made Plate in Orthognathic Surgery

Orthognathic surgery has traditionally been used to correct dentofacial deformities. Conventional methods rely on 2D radiographic images, occlusal splints, and dental casts, but these approaches have limitations, such as errors during face-bow transfer. Technological advancements, including 3D imaging, virtual surgical planning (VSP), and computer-aided design and manufacturing (CAD/CAM), have improved the precision and outcomes of orthognathic surgery.

This study included one group of patients need orthognathic surgery and fixation of maxilla using custom made plate designed by 3D virtual planning using Materialize mimic soft ware

Eligibility Criteria:
Inclusion Criteria:

* Patients with skeletal class II or class III who need orthognathic surgery.
* Patients who suffer from clinical facial asymmetry.
* Patients with occlusal plane canting.
* Age range of patients 18-40 years old, with no gender prediction, able to read and sign the informed consent.

Exclusion Criteria:

* Maxillofacial trauma
* Patients who suffer from maxillofacial tumors
* Segmental maxillary surgery.
* Oral soft tissues defects, infections and bone metabolism disturbance.
* Allergy to titanium implant.
* Patient with systemic disease and immunocompromised patient.