cyrilzakka/clinical-trials huggingface dataset:
Neoadjuvant Dalpiciclib Plus Aromatase Inhibitors in Luminal B/HER2-negative Breast Cancer (DANCER)

Evaluate the efficacy and safety of Dalpiciclib combined with aromatase inhibitors as a neoadjuvant therapy in Luminal B/HER2-negative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years-old at the time of consent to participate this trial
* Famale stage I-III breast cancer patients
* HR-positive（ER≥10%）, HER2-negtive invasive breast cancer, either Ki67≥20% and/or PgR\<20%
* No prior anti-cancer treatment
* ECOG 0-1

Exclusion Criteria:

* Known to have other aggressive malignant tumor in the past 5 years.
* Bilateral breast cancer; Inflammatory breast cancer; Occult breast cancer; Distant metastasis confirmed by pathology.
* There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia.
* Female patients during pregnancy or lactation.
* The investigator determines that subjects are not appropriate to participate in the study due to other factors.
A Study to Evaluate the Safety of CNTO 2476 in Patients With Advanced Retinitis Pigmentosa

The main purpose of this study is to evaluate the preliminary safety and immunogenicity (ability of an antigen to provoke immune response in the human body) of CNTO 2476, administered subretinally, in participants with advanced retinitis pigmentosa (RP; disease of the eye that leads to loss of vision and blindness) with either light perception only (LP) or hand motion (HM).

The study will be an open-label (all people know the identity of the intervention), first in human safety study. Nine adult men and women with advanced RP with LP only (first 5 participants) or not better than HM bilaterally (subsequent 4 participants) in both eyes will be enrolled. Participant 5 may have combination visual acuity of LP in the treated eye and no better than HM in the fellow eye. Treatment will proceed on a cohort basis ie, Cohort I: Participant 1; Cohort II: Participant 2; Cohort III: Participant 3 and 4; Cohort IV: Participant 5, 6, and 7; and Cohort V: Participant 8 and 9. The initial participants for each cohort must have completed at least 4 weeks of post-treatment follow-up before participants in the next cohort may be treated. There are 2 safety assessment phases in this study: the main phase approximately 12 months from the time the participant is eligible to enter the study and the long-term safety follow-up phase of 4 additional years. The total length of the participation in the study could last up to 5 years (including both the main and safety follow-up phases).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of retinitis pigmentosa that is not part of another systemic disease
* Vision deficit characterized by vision that is not better than either light perception (Group 1) or hand motion (Group 2) in both eyes
* Normal hematology and chemistry lab results
* Participant is suitable candidate for ophthalmologic surgery

Exclusion Criteria:

* Other significant ophthalmologic diseases or any other ophthalmologic condition that interferes with ophthalmologic examination
* Women of childbearing potential
* Ocular hypertension
* Other serious medical conditions
Clinical Predictors for Venous Thromboembolism in Patients With a History of Thrombosis (PREDICTORS)

Patients with a history of blood clots are at risk of developing additional clots in the future. Doctors use a tool called a clinical decision rule to tell them how likely it is that a patient has a blood clot and if they should have further testing to look for the clot. This tool may cause doctors to over-diagnosis a recurrent clot because the symptoms may be left over from the previous clot. Correctly diagnosing a recurrent blood clot is very important since there are risks associated with both over-diagnosis and under-diagnosis. If a recurrent blood clot is missed (under-diagnosis) the patient is at risk of death from a clot in the lungs. If blood thinners are prescribed when they are not needed (over-diagnosis), the patient may have to take blood thinners for their lifetime and risk having serious bleeding.

Several tools have been developed to standardize the diagnostic management of a suspected first blood clot. One of these tools is the use of a clinical decision rule. Clinical decision rules have been designed to help clinicians make diagnostic and therapeutic decisions at the bedside. A score is computed on the presence of some criteria from the patient's medical history, clinical signs and symptoms. The score provides the probability of a blood clot. The rules can be used in combinations with a simple blood test - called D-dimer - to identify patients at low risk who don't require diagnostic imaging testing. Benefits include reduced costs, length in hospital and radiation exposure.

Patients with prior blood clots have been shown to be less likely to benefit from the non-invasive testing. Therefore, they often need to undergo imaging tests, which are frequently difficult to interpret in patients with prior blood clots since residual clots are often present and are difficult to distinguish from a recurrent clot.

The objective of this study is to try to prospectively assess the role of existing clinical decision rules in patients with prior blood clots, and to attempt to improve them in order to increase the yield of non-invasive testing and to reduce the risk of over-diagnosis with imaging tests.

With respect to this study, clots within the deep veins of the legs are called deep vein thrombosis (DVT), while clots in the lungs are called pulmonary embolism (PE).

Eligibility Criteria:
Inclusion Criteria:

* Outpatients with clinically suspected acute recurrent DVT or PE regardless of whether the previous event was a DVT or PE
* Age ≥18 years old
* Willing and able to give informed consent

Exclusion Criteria:

* Life expectancy less than 3 months
* Suspicion of upper extremity thrombosis or thrombosis at an unusual site (e.g. cerebral or abdominal venous thrombosis)
* Previous VTE was distal DVT or subsegmental PE
* Suspected recurrent VTE is asymptomatic
* Previously enrolled in this study
Phase IIa Study of WBI-1001 Cream for Atopic Dermatitis

WBI-1001 is a synthetic,new, non-steroid, small molecule being developed as a candidate drug for the topical, cream treatment of inflammatory skin diseases. As such, it affects T-cells through inhibition of T-cell activities including their infiltration processes, and it shows direct anti-inflammatory manifestation in the mouse edema model. This was a 28 day study (plus one follow-up week) on patients with Atopic Dermatitis, and 36 patients were treated randomly, BID with either 0.5%, 1.0% or placebo. Blood samples were taken weekly for PK analysis.

A double-blind, single-centered, vehicle-controlled, randomized Phase IIa study of WBI-1001 on patients with mild to moderate Atopic Dermatitis (AD). All body areas were treatable except face, scalp, groin and genital areas. Cream applied BID between 6.00 and 10.00am and 7.00 and 10.00pm daily for 4 weeks. Blood draws for PK analysis were taken weekly at the study centre prior to the morning cream application. Patients returned to the study centre approximately one week later for a follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* AD diagnosis (based on Hanifin's criteria) presenting a minimum of 1% and a maximum of 10% body surface area (BSA) excluding face, groin, scalp and genital areas.
* Disease severity index (EASI) of less than 12, Investigator's Global Assessment (IGA) of 2-3 at Day 0.
* In good general health and free of any condition that might impair evaluation of AD.
* Women of child bearing potential (WOCBP) had to have a negative a negative serum human-beta chorionic gonadotropin pregnancy test before randomization.

WOCBP had to abstain from sex or they and their partners had to use adequate contraceptive precautions for the duration of the study.

* Willing and able to comply with the protocol and attend all study visits.
* Provide a written informed consent form prior to initiation of study procedures.

Exclusion Criteria:

* Had spontaneously improving or rapidly deteriorating AD.
* Had AD lesions on only hands and/or feet.
* Had skin diseases other than AD.
* Had active allergic contact dermatitis or other non-atopic forms of dermatitis.
* Had other concomitant medical condition that could put the patient at risk during the study.
* Had a history of neurological/psychiatric disorders that could interfere with the patient's participation.
* Had systemic immunomodulatory therapies within 12 weeks prior to the baseline visit.
* Had prolonged exposure to natural or artificial ultraviolet radiation within 4 weeks of baseline visit.
* Had phototherapy (including laser), photo-chemotherapy or systemic AD therapy within 4 weeks prior to baseline visit.
* Had topical AD therapies in the areas to be treated within 2 weeks prior to the baseline visit.
* Had alcohol abuse in the last 2 years.
* Had allergic history to any non-medical ingredients of the study cream.
* Were treated with an investigational drug within 1 month of Day 0 or were currently participating in another trial.
Effects of Regular Exercise on Adult Asthma

The purpose of this study is to assess the effects of regular exercise on physical fitness, asthma control, and quality of life among adult asthmatics.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of asthma made by physician, or reimbursement for asthma medication from the National Social Insurance Institution of Finland (code 203), or patient fulfills the diagnostic criteria for asthma as outlined in the Finnish Guidelines for Asthma Management (Käypä hoito -suositus 2006 and 2012)

Exclusion Criteria:

* FEV1 \< 60 % of predicted in spirometry
* PEF variability \> 30 % at least 2 times during a 1-week monitoring period
* use of bronchodilating medication at least 4 times daily
* permanent, daily steroid tablet treatment
* patients who exercise regularly already at baseline at least 3 times a week at least 30 min at a time
* serious coronary heart disease
* severe hypotension
* severe heart failure
* severe musculoskeletal disorder
* dementia
* physician-diagnosed chronic obstructive lung disease
Effects of an Antioxidant Supplement on Blood Vessel Health

Cardiovascular disease (CVD) is a leading cause of morbidity and mortality worldwide, and the non-Hispanic Black (NHB) population is disproportionately affected. Our research has previously demonstrated that oxidative stress may contribute to reduced vascular function in otherwise healthy NHB adults, potentially predisposing them to the development of hypertension and CVD. This study is designed to examine whether the mitochondria are an important source of oxidative stress-induced vascular dysfunction in healthy NHB adults.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as either non-Hispanic Black or non-Hispanic White.
* Men and women 18-75 years old.
* Non-hypertensive (systolic blood pressure \[SBP\]\<130 and diastolic blood pressure \[DBP\] \<85 mmHg).
* Have low density lipoprotein cholesterol \<150mg/dl.
* Have HbA1C \<6.0%.

Exclusion Criteria:

* Rash, skin disease, or disorders of pigmentation (e.g., psoriasis, eczema, vitiligo, or other skin inflammatory skin disorders)
* Known skin allergies to latex or adhesives
* Smoking and/or use of nicotine-containing products within the past year
* Use of illegal/recreational drugs
* Generalized kidney disease
* Taking chloramphenicol, cholestyramine, medication for seizures, methotrexate, nitrofurantoin, tetracycline, barbiturates, steroids, phenobarbital/phenytoin, orlistat or pyrimethamine
* Any current medications which could conceivably alter the cardiovascular control or responses
* Diagnosed or suspected metabolic or cardiovascular disease
* Current pregnancy or breastfeeding
* History of skin or other cancers
* Diagnosed or suspected diabetes (HbA1c ≥6.0)
* Anybody with narcolepsy or who has been diagnosed with any condition that impairs body temperature regulation.
Biliary Hilar Drainage Managed by Endoscopy

The management of hilar biliary strictures remains difficult. These strictures are classified in 4 types (I,II,III and IV). In palliative cases, an endoscopic drainage should be performed in types I and II while a percutaneous drainage is performed in type IV. There is controversy as to whether partial or complete liver drainage should be done. Furthermore there are no standards for drainage types (metallic stents, plastic stents). Morbidity remains high and a multistage procedure can be required.

This study aims at evaluating the clinical practices in the investigators' center in order to determine the key factors that contribute to the drainage success or failure.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Biliary strictures requiring a drainage

Exclusion Criteria:

* Contraindication to hilar biliary drainage
Effects of Using E-Cigarettes on Lungs in People With HIV (HBS Ancillary)

This is an ancillary study, thus participants will be recruited from participants in the HBS Study. This project acutely assesses the role of the e-cigarettes and vaping on lung health. The proposed work will inform the design of future studies to better understand vaping's health consequences and to test novel interventions to mitigate vaping's contribution to acute and/or chronic lung injury.


Eligibility Criteria:
This project is an ancillary study to the HBS Study. Inclusion Criteria for that IRB approved study are:

* documented HIV-infection
* in care at an HIV specialty clinic
* age ≥ 18 years.

Exclusion criteria for the HBS Study are:

* a pacemaker or other implanted electronic device
* pregnant women, prisoners, cognitively-impaired subjects.

For this ancillary, the experimental group must actively use at least one of the following: e-cigarettes, e-liquid vapes, burning leaf tobacco cigarettes, or inhaled burning leaf marijuana (cannabis). The control group will have no use of e-cigarettes or vape or active smoking in the past year.

Participants must be willing to archive data and biological samples for future use.

Exclusion from the ancillary are:

* overt respiratory or oral cavity disease
* acute illness in the past 4 weeks
* active cancer
* active weight loss program
* any other medical, psychiatric or behavioral factors that, in the judgment of the PI may interfere with study participation or ability to follow the protocol
Comparison of the Total Dose and Efficacy of Two Lidocaine Concentrations Needed for Cutaneous Surgery Local Anesthesia

The purpose of the study will be to demonstrate whether Mohs micrographic surgery can be performed with a lower total dose of local anesthesia (and greater patient safety) when using 0.5% lidocaine with 1:200,000 epinephrine versus 1% lidocaine with 1:100,000 epinephrine.

The purpose of the study will be to demonstrate whether Mohs micrographic surgery can be performed with a lower total dose of local anesthesia (and greater patient safety) when using 0.5% lidocaine with 1:200,000 epinephrine versus 1% lidocaine with 1:100,000 epinephrine. Mohs micrographic surgery is a multi-staged, same-day procedure used to remove skin cancers under local anesthesia. Reconstruction of the surgical wound is also performed under local anesthesia, usually immediately after achieving tumor clearance.

This randomized, double-blind study will systematically compare the total dose of 1.0% lidocaine with 1:100,000 epinephrine versus 0.5% of lidocaine with 1:200,000 epinephrine needed to achieve local anesthesia during Mohs micrographic surgery (MMS). All healthy adult volunteers (18 years or older) undergoing Mohs micrographic surgery at the Hospital of the University of Pennsylvania's Department of Dermatology and Dermatologic Surgery between June 1, 2007 and August 31, 2007 will be eligible to participate in the study. Our primary intervention will be to record the total dose of lidocaine administered throughout all of the MMS stages and reconstructions using either of the two lidocaine concentrations. A secondary intervention will be to record each patient's level of pain control in order to demonstrate that patient comfort is effectively achieved with a lower total dose of local anesthesia. Pregnant or breast-feeding subjects, those with a history of allergic or other adverse reaction to lidocaine or epinephrine, and those who are cognitively impaired will be excluded. In addition, if the surgeon believes that a patient has a tumor which, due to size or anatomic site, may put him at risk for requiring a dose of lidocaine that approaches the threshold of toxicity, this patient will be excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Mohs micrographic surgery patient

Exclusion Criteria:

* Pregnant or breast-feeding subjectsH
* History of allergic or other adverse reaction to lidocaine or epinephrine
* Cognitively impairment
* Surgeon judges patient a risk for lidocaine toxicity due to tumor size
Efficacy of Carbetocin in Prevention of Postpartum Hemorrhage in Obese Versus Non Obese Women

Postpartum hemorrhage \[PPH\] can have serious consequences and is the leading cause of maternal mortality globally. Uterine contractility plays an important role in post-delivery uterine involution; impaired contractility can contribute to PPH. Should contractility be impaired among obese women, there would be implications for management. Therefore, the investigators sought to investigate whether obese women would also experience a need for more uterine agents during the management of an obstetric hemorrhage.

The American College of Obstetricians and Gynecologists (ACOG) updated their definition of postpartum hemorrhage (PPH) to be "blood loss greater than or equal to 1000 ml or blood loss accompanied by signs or symptoms of hypovolemia" .

Recent clinical and translational studies have suggested a decrease in uterine contractility among obese and morbidly obese women as a primary cause of obstetric hemorrhage.

In the United States, the prevalence of maternal obesity has been steadily rising, with more than half of pregnant women classified as overweight or obese. A panel of obstetric experts has speculated that the rising prevalence of maternal obesity in developed countries may explain the increase in postpartum hemorrhage incidence.

Uterotonic drugs are recommended to reduce blood loss and the risk of postpartum hemorrhage (PPH) after Cesarean delivery.

There are several prophylactic uterotonic agents available for use, including oxytocin, oxytocin/ergometrine, and carbetocin. Carbetocin is a synthetic analog of oxytocin which provides a longer duration of action than oxytocin (half-life 85-100 min versus 3-4 min).

The investigators aim to investigate the impact of carbetocin on uterine contractility in obese versus non-obese pregnant women undergoing elective cesarean delivery following carbetocin 100 mcg bolus IV administration as a prophylaxis of postpartum hemorrhage in a randomized controlled trial. The incestigators hypothesize that increased volume of distribution reduces the bioavailability of carbetocin and may be an explanation for reduced efficacy. Also the investigators will examine uterine tone as a surrogate marker for the bioavailability of carbetocin.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women with a singleton pregnancy undergoing a Cesarean delivery after at least 37 completed weeks of gestation under regional anesthesia.
* Aged (18-39) years and with signed informed consent.

Exclusion Criteria:

* Emergency Cesarean Section due to fetal distress.
* Maternal comorbidities such as severe cardiovascular disorders, kidney or liver disorders, coagulopathies, as well as epilepsy.
* Uterine malformation.
* Fetal malformation.
* Known hypersensitivity to carbetocin or oxytocin.
* Uterine overdistention (as in polyhydramnios, twins, and fetal macrosomia)
* Injury of uterine vessels during CS.
Neurodevelopmental Outcomes in Children: Strengthening the Caregiver-Child Story

The main goal of this research is to help families who are experiencing food insecurity (FI) and help mothers with depression.

The next goal is to provide other resources to help with household needs like rent or utility assistance, health insurance, anxiety, and depression. Our theory is that helping with food insecurity, household needs, and emotional health will help children and families.

Aim 1: Implement a refined mental health (MH) intervention in caregivers of hospitalized children: sessions with a Behavioral Health Clinician (BHC) with more individualized support based on caregiver-child needs, instruction on caregiver-child bonding, and a streamlined handoff to a community MH provider. Follow-up outcomes include caregiver MH and caregiver-child attachment (survey) and child development (electronic health records, EHR).

Aim 2: Execute an enhanced intervention for FI. All families who screen positive for FI will still receive assistance with public benefit enrollment and access to local food pantries. Families with additional needs will receive support for 10 additional non-medical drivers of health (NMDH). Assistance will be provided by onsite Houston Food Bank (HFB) Community Referral Specialists. Follow-up outcomes include enrollment in public/community resources and food security status (survey).

Eligibility Criteria:
Inclusion Criteria:

* Caregivers of young children (0-36 months of age) hospitalized at Texas Children's Hospital on acute care units.
* English or Spanish speaking caregiver.
* Age of caregiver ≥ 18 years old.
* Hospital day 2 or later of patient admission.

Exclusion Criteria:

* Caregivers who do not have primary custody
* Children in CPS custody
* Caregivers who live outside of Texas (due to lack of Houston Food Bank resources outside of Texas)
* Previous enrollment in this study.
* Patient is in the process of being discharged/observation status administration.
* Caregiver is not the primary caregiver.
Efficacy of PreOperative Bevacizumab for Diabetic Eye Disease

Reports of the use of intravitreal bevacizumab (Avastin, Genentech) for the reduction of neovascularization in proliferative diabetic retinopathy have demonstrated significant regression in the number of new vessels. Reducing the vascularity of neovascular fibrovascular tissue can potentially reduce bleeding intraoperatively and thus facilitate the vitrectomy procedure. The investigators chose to investigate the potential benefit of the use of preoperative bevacizumab in the management of these most complex cases.

PURPOSE: To evaluate the role of preoperative intravitreal bevacizumab as an adjunct to vitrectomy in the management of severe diabetic eye disease.

SETTINGS: Kasr El-Aini Teaching Hospital - Cairo University from 2007 to 2008. METHODS: Twenty eyes of 19 patients with severe proliferative diabetic retinopathy were recruited into the study. All eyes underwent a single intravitreal injection of bevacizumab 1.25 mg in 0.05 ml one week prior to vitrectomy for tractional (14), combined tractional/rhegmatogenous retinal detachment (4), and fibrovascular tissue covering/distorting the macula (2). Exclusion criteria were: previous vitrectomy, neovascular glaucoma, and dense media opacity (dense cataract and vitreous hemorrhage) precluding fluorescein angiography (FA) that was done pre- and 1 week post injections. Best corrected visual acuity (BCVA), anterior segment with dilated fundus examinations, and intraocular pressures (IOP), were done pre-, 1 week post-injections, 1 day, 1 week and monthly for 3 months post-vitrectomy. Intra- and post-operative bleedings were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Tractional Retinal Detachment involving or threatening the macula,
* Tractional+Rhegmatogenous Retinal Detachment, or
* Fibrovascular tissue covering and distorting the macula.

Exclusion Criteria:

* Vitrectomy
* Neovascular glaucoma
* Dense media opacity (dense cataract and vitreous hemorrhage) precluding fluorescein angiography (FA)